Trial Outcomes & Findings for Salvage Oligometastasectomy and Radiation Therapy in Recurrent Prostate Cancer (NCT NCT03796767)
NCT ID: NCT03796767
Last Updated: 2026-01-28
Results Overview
The primary outcome measure will report the count of patients achieving a PSA decline \>= 50% at 6 months after completion of treatment (salvage + - adjuvant). Prostate-Specific Antigen (PSA) is a protein produced by tissue in the prostate. An elevated PSA value can be a sign of prostate cancer.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
6 months after completion of 5-21 weeks of treatment
Results posted on
2026-01-28
Participant Flow
Participant milestones
| Measure |
Arm A (Radiation Therapy)
Patients with bone metastases undergo SBR) or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion.
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Stereotactic Body Radiation Therapy: Undergo SBRT
|
Arm B (Salvage Oligometastasectomy)
Patients with nodal metastases undergo salvage oligometastasectomy.
Metastasectomy: Undergo salvage oligometastasectomy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm C (Salvage Oligometastasectomy, Radiation Therapy)
Patients with nodal metastases undergo salvage oligometastasectomy. Following recovery, patients undergo SBRT or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion. Within 4 months following completion of salvage therapy (defined as the combination of oligometastasectomy and/or bone radiation) and depending on PSA response as well as previous treatment, patients may receive adjuvant nodal IMRT.
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Intensity-Modulated Radiation Therapy: Undergo IMRT
Metastasectomy: Undergo salvage oligometastasectomy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Stereotactic Body Radiation Therapy: Undergo SBRT
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
18
|
0
|
|
Overall Study
COMPLETED
|
2
|
18
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Salvage Oligometastasectomy and Radiation Therapy in Recurrent Prostate Cancer
Baseline characteristics by cohort
| Measure |
Arm A (Radiation Therapy)
n=2 Participants
Patients with bone metastases undergo SBR) or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion.
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Stereotactic Body Radiation Therapy: Undergo SBRT
|
Arm B (Salvage Oligometastasectomy)
n=18 Participants
Patients with nodal metastases undergo salvage oligometastasectomy.
Metastasectomy: Undergo salvage oligometastasectomy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm C (Salvage Oligometastasectomy, Radiation Therapy)
Patients with nodal metastases undergo salvage oligometastasectomy. Following recovery, patients undergo SBRT or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion. Within 4 months following completion of salvage therapy (defined as the combination of oligometastasectomy and/or bone radiation) and depending on PSA response as well as previous treatment, patients may receive adjuvant nodal IMRT.
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Intensity-Modulated Radiation Therapy: Undergo IMRT
Metastasectomy: Undergo salvage oligometastasectomy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Stereotactic Body Radiation Therapy: Undergo SBRT
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
0 Participants
n=153 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=158 Participants
|
8 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
10 Participants
n=153 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=158 Participants
|
10 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
10 Participants
n=153 Participants
|
|
Age, Continuous
|
61.50 Years
STANDARD_DEVIATION 0.71 • n=158 Participants
|
66.50 Years
STANDARD_DEVIATION 6.84 • n=157 Participants
|
—
|
66.00 Years
STANDARD_DEVIATION 6.66 • n=153 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
0 Participants
n=153 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=158 Participants
|
18 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
20 Participants
n=153 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=158 Participants
|
1 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
2 Participants
n=153 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=158 Participants
|
17 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
18 Participants
n=153 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
0 Participants
n=153 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
0 Participants
n=153 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
0 Participants
n=153 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
0 Participants
n=153 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
0 Participants
n=153 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=158 Participants
|
17 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
18 Participants
n=153 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
0 Participants
n=153 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=158 Participants
|
1 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
2 Participants
n=153 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=158 Participants
|
18 participants
n=157 Participants
|
—
|
20 participants
n=153 Participants
|
|
Height
|
173.9 cm
STANDARD_DEVIATION 5.39 • n=158 Participants
|
177.78 cm
STANDARD_DEVIATION 7.32 • n=157 Participants
|
—
|
177.40 cm
STANDARD_DEVIATION 7.13 • n=153 Participants
|
|
Weight
|
180.00 kg
STANDARD_DEVIATION 11.31 • n=158 Participants
|
93.02 kg
STANDARD_DEVIATION 11.94 • n=157 Participants
|
—
|
91.72 kg
STANDARD_DEVIATION 12.26 • n=153 Participants
|
|
BMI
|
26.35 kg/m^2
STANDARD_DEVIATION 2.11 • n=158 Participants
|
29.43 kg/m^2
STANDARD_DEVIATION 3.27 • n=157 Participants
|
—
|
29.12 kg/m^2
STANDARD_DEVIATION 3.27 • n=153 Participants
|
|
PSA at Time of Initial Definitive Treatment
|
9.80 ng/mL
STANDARD_DEVIATION 7.78 • n=158 Participants
|
9.18 ng/mL
STANDARD_DEVIATION 14.01 • n=157 Participants
|
—
|
9.24 ng/mL
STANDARD_DEVIATION 13.37 • n=153 Participants
|
|
Number of Nodal Lesions Present
|
0 Lesions
n=158 Participants
|
2.06 Lesions
n=157 Participants
|
—
|
1.85 Lesions
n=153 Participants
|
|
ECOG
0 Fully active
|
1 Participants
n=158 Participants
|
18 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
19 Participants
n=153 Participants
|
|
ECOG
1 Restricted
|
1 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
1 Participants
n=153 Participants
|
|
ECOG
2 Ambulatory
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
0 Participants
n=153 Participants
|
|
ECOG
3 Limited selfcare
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
0 Participants
n=153 Participants
|
|
ECOG
4 Completely disabled
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
0 Participants
n=153 Participants
|
|
ECOG
5 Dead
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
0 Participants
n=153 Participants
|
|
Histology
Adenocarcinoma of the prostate
|
2 Participants
n=158 Participants
|
18 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
20 Participants
n=153 Participants
|
|
Histology
Adenocarcinoma of the prostate + secondary histology
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
0 Participants
n=153 Participants
|
|
Total Gleason at Definitive Treatment
6
|
0 Participants
n=158 Participants
|
1 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
1 Participants
n=153 Participants
|
|
Total Gleason at Definitive Treatment
7
|
1 Participants
n=158 Participants
|
13 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
14 Participants
n=153 Participants
|
|
Total Gleason at Definitive Treatment
8
|
1 Participants
n=158 Participants
|
1 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
2 Participants
n=153 Participants
|
|
Total Gleason at Definitive Treatment
9
|
0 Participants
n=158 Participants
|
3 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
3 Participants
n=153 Participants
|
|
T Stage
T2
|
0 Participants
n=158 Participants
|
2 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
2 Participants
n=153 Participants
|
|
N Stage
N0
|
2 Participants
n=158 Participants
|
11 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
13 Participants
n=153 Participants
|
|
T Stage
T2a
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
0 Participants
n=153 Participants
|
|
T Stage
T2b
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
0 Participants
n=153 Participants
|
|
T Stage
T2c
|
0 Participants
n=158 Participants
|
5 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
5 Participants
n=153 Participants
|
|
T Stage
T3
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
0 Participants
n=153 Participants
|
|
T Stage
T3a
|
2 Participants
n=158 Participants
|
6 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
8 Participants
n=153 Participants
|
|
T Stage
T3b
|
0 Participants
n=158 Participants
|
5 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
5 Participants
n=153 Participants
|
|
N Stage
NX (regional lymph nodes cannot be assessed)
|
0 Participants
n=158 Participants
|
1 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
1 Participants
n=153 Participants
|
|
N Stage
N1
|
0 Participants
n=158 Participants
|
5 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
5 Participants
n=153 Participants
|
|
N Stage
Unknown / Not assessed
|
0 Participants
n=158 Participants
|
1 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
1 Participants
n=153 Participants
|
|
M Stage
M0
|
2 Participants
n=158 Participants
|
6 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
8 Participants
n=153 Participants
|
|
M Stage
M1
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
0 Participants
n=153 Participants
|
|
M Stage
Unknown / Not assessed
|
0 Participants
n=158 Participants
|
12 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
12 Participants
n=153 Participants
|
|
Overall Stage
Stage IIB
|
0 Participants
n=158 Participants
|
3 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
3 Participants
n=153 Participants
|
|
Overall Stage
Stage IIIA
|
0 Participants
n=158 Participants
|
2 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
2 Participants
n=153 Participants
|
|
Overall Stage
Stage IIIB
|
2 Participants
n=158 Participants
|
1 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
3 Participants
n=153 Participants
|
|
Overall Stage
Stage IIIC
|
0 Participants
n=158 Participants
|
2 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
2 Participants
n=153 Participants
|
|
Overall Stage
Stage IVA
|
0 Participants
n=158 Participants
|
2 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
2 Participants
n=153 Participants
|
|
Overall Stage
Stage IVB
|
0 Participants
n=158 Participants
|
1 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
1 Participants
n=153 Participants
|
|
Prior radiotherapy
Definitive Radiotherapy - Prostate (should be salvage radiation - prostate)
|
0 Participants
n=158 Participants
|
2 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
2 Participants
n=153 Participants
|
|
Overall Stage
Unknown / Not assessed
|
0 Participants
n=158 Participants
|
7 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
7 Participants
n=153 Participants
|
|
Prior radiotherapy
None
|
0 Participants
n=158 Participants
|
11 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
11 Participants
n=153 Participants
|
|
Prior radiotherapy
Adjuvant/Salvage Radiotherapy - Prostate
|
0 Participants
n=158 Participants
|
4 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
4 Participants
n=153 Participants
|
|
Prior radiotherapy
Adjuvant/Salvage Radiotherapy - Pelvis + Prostate
|
2 Participants
n=158 Participants
|
1 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
3 Participants
n=153 Participants
|
|
Prior exposer to Androgen deprivation therapy (ADT)
Yes
|
1 Participants
n=158 Participants
|
5 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
6 Participants
n=153 Participants
|
|
Prior exposer to Androgen deprivation therapy (ADT)
No
|
1 Participants
n=158 Participants
|
13 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
14 Participants
n=153 Participants
|
PRIMARY outcome
Timeframe: 6 months after completion of 5-21 weeks of treatmentPopulation: No participants were enrolled in Arm C.
The primary outcome measure will report the count of patients achieving a PSA decline \>= 50% at 6 months after completion of treatment (salvage + - adjuvant). Prostate-Specific Antigen (PSA) is a protein produced by tissue in the prostate. An elevated PSA value can be a sign of prostate cancer.
Outcome measures
| Measure |
Arm A (Radiation Therapy)
n=2 Participants
Patients with bone metastases undergo SBR) or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion.
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Stereotactic Body Radiation Therapy: Undergo SBRT
|
Arm B (Salvage Oligometastasectomy)
n=18 Participants
Patients with nodal metastases undergo salvage oligometastasectomy.
Metastasectomy: Undergo salvage oligometastasectomy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm C (Salvage Oligometastasectomy, Radiation Therapy)
Patients with nodal metastases undergo salvage oligometastasectomy. Following recovery, patients undergo SBRT or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion. Within 4 months following completion of salvage therapy (defined as the combination of oligometastasectomy and/or bone radiation) and depending on PSA response as well as previous treatment, patients may receive adjuvant nodal IMRT.
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Intensity-Modulated Radiation Therapy: Undergo IMRT
Metastasectomy: Undergo salvage oligometastasectomy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Stereotactic Body Radiation Therapy: Undergo SBRT
|
|---|---|---|---|
|
Prostate-specific Antigen (PSA) ≥ 50% 6 Months After Completion of All Treatment
Yes
|
0 Participants
|
8 Participants
|
0 Participants
|
|
Prostate-specific Antigen (PSA) ≥ 50% 6 Months After Completion of All Treatment
No
|
2 Participants
|
10 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 months after completion of 5-21 weeks of treatmentPopulation: No participant was enrolled on Arm C
Defined according to Prostate Cancer Working Group (PCWG3) criteria as the proportion of patients achieving a PSA decline \>= 50% at 12 months after completion of treatment (salvage + - adjuvant). Prostate-Specific Antigen (PSA) is a protein produced by tissue in the prostate. An elevated PSA value can be a sign of prostate cancer.
Outcome measures
| Measure |
Arm A (Radiation Therapy)
n=2 Participants
Patients with bone metastases undergo SBR) or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion.
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Stereotactic Body Radiation Therapy: Undergo SBRT
|
Arm B (Salvage Oligometastasectomy)
n=18 Participants
Patients with nodal metastases undergo salvage oligometastasectomy.
Metastasectomy: Undergo salvage oligometastasectomy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm C (Salvage Oligometastasectomy, Radiation Therapy)
Patients with nodal metastases undergo salvage oligometastasectomy. Following recovery, patients undergo SBRT or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion. Within 4 months following completion of salvage therapy (defined as the combination of oligometastasectomy and/or bone radiation) and depending on PSA response as well as previous treatment, patients may receive adjuvant nodal IMRT.
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Intensity-Modulated Radiation Therapy: Undergo IMRT
Metastasectomy: Undergo salvage oligometastasectomy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Stereotactic Body Radiation Therapy: Undergo SBRT
|
|---|---|---|---|
|
Prostate-specific Antigen (PSA) ≥ 50% 12 Months After Completion of All Treatment
Yes
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Prostate-specific Antigen (PSA) ≥ 50% 12 Months After Completion of All Treatment
No
|
1 Participants
|
14 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 and 12 months after completion of 5-21 weeks of treatment 6 Months After Completion of All Treatment6 Months After Completion of All TreatmentPopulation: No participants were enrolled in Arm C.
This outcome will report the count of patients achieving a PSA decline ≥ 90% 6 at 6 and12 months after completion of treatment (salvage + - adjuvant). Prostate-Specific Antigen (PSA) is a protein produced by tissue in the prostate. An elevated PSA value can be a sign of prostate cancer.
Outcome measures
| Measure |
Arm A (Radiation Therapy)
n=2 Participants
Patients with bone metastases undergo SBR) or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion.
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Stereotactic Body Radiation Therapy: Undergo SBRT
|
Arm B (Salvage Oligometastasectomy)
n=18 Participants
Patients with nodal metastases undergo salvage oligometastasectomy.
Metastasectomy: Undergo salvage oligometastasectomy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm C (Salvage Oligometastasectomy, Radiation Therapy)
Patients with nodal metastases undergo salvage oligometastasectomy. Following recovery, patients undergo SBRT or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion. Within 4 months following completion of salvage therapy (defined as the combination of oligometastasectomy and/or bone radiation) and depending on PSA response as well as previous treatment, patients may receive adjuvant nodal IMRT.
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Intensity-Modulated Radiation Therapy: Undergo IMRT
Metastasectomy: Undergo salvage oligometastasectomy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Stereotactic Body Radiation Therapy: Undergo SBRT
|
|---|---|---|---|
|
Prostate-specific Antigen (PSA) ≥ 90%
PSA decline ≥ 90% at 6 Months · Yes
|
0 Participants
|
5 Participants
|
0 Participants
|
|
Prostate-specific Antigen (PSA) ≥ 90%
PSA decline ≥ 90% at 6 Months · No
|
2 Participants
|
13 Participants
|
0 Participants
|
|
Prostate-specific Antigen (PSA) ≥ 90%
PSA decline ≥ 90% at 12 Months · Yes
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Prostate-specific Antigen (PSA) ≥ 90%
PSA decline ≥ 90% at 12 Months · No
|
2 Participants
|
14 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Time elapsed between study enrollment and first occurrence of confirmed radiographic disease progression, assessed up to 3 yearsThe proportion of subjects without PSA progression (defined using Prostate Cancer Working Group 3 Criteria PCWG3), evaluated every 3 months for 3 years after completion of all treatment (salvage and adjuvant therapy).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time elapsed between study enrollment and confirmed radiographic disease progression, up to 3 yearsThe time from study enrollment until the date of confirmed radiographic disease progression as defined by RECIST 1.1 and PCWG3.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsThe time from study enrollment to the initiation of ADT
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 and 12 months after completion of 5-21 weeks of treatmentPopulation: No participants were enrolled in Arm C
This outcome measure will report the count of participants with undetectable PSA after 6 and 12 months following completion of treatment (salvage ± adjuvant). Undetectable PSA is defined as the number of patients ever treated with prostatectomy whose PSA remains ≤ 0.2 ng/mL.
Outcome measures
| Measure |
Arm A (Radiation Therapy)
n=2 Participants
Patients with bone metastases undergo SBR) or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion.
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Stereotactic Body Radiation Therapy: Undergo SBRT
|
Arm B (Salvage Oligometastasectomy)
n=18 Participants
Patients with nodal metastases undergo salvage oligometastasectomy.
Metastasectomy: Undergo salvage oligometastasectomy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm C (Salvage Oligometastasectomy, Radiation Therapy)
Patients with nodal metastases undergo salvage oligometastasectomy. Following recovery, patients undergo SBRT or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion. Within 4 months following completion of salvage therapy (defined as the combination of oligometastasectomy and/or bone radiation) and depending on PSA response as well as previous treatment, patients may receive adjuvant nodal IMRT.
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Intensity-Modulated Radiation Therapy: Undergo IMRT
Metastasectomy: Undergo salvage oligometastasectomy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Stereotactic Body Radiation Therapy: Undergo SBRT
|
|---|---|---|---|
|
Undetectable PSA
PSA ≤ 0.2 at 6 months · Yes
|
0 Participants
|
7 Participants
|
0 Participants
|
|
Undetectable PSA
PSA ≤ 0.2 at 6 months · No
|
2 Participants
|
11 Participants
|
0 Participants
|
|
Undetectable PSA
PSA ≤ 0.2 at 12 months · Yes
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Undetectable PSA
PSA ≤ 0.2 at 12 months · No
|
1 Participants
|
14 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 12 months after completion of 5-21 weeks of treatmentPopulation: No participants were enrolled in Arm C.
This outcome measure will assess the safety and tolerability of the study treatment. The severity of AEs was assessed using CTCAE v5.0 criteria, a 1-5 scale with higher numbers indicating greater severity. Grade 1 indicates "mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated" and Grade 5 indicates "death related to AE". This outcome measure will report the count of participants who experienced each AE grade. Subjects were monitored for adverse events from the start of treatment until 28 days after the last dose of the study drug. Adverse events were collected every three months for one year after treatment discontinuation.
Outcome measures
| Measure |
Arm A (Radiation Therapy)
n=2 Participants
Patients with bone metastases undergo SBR) or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion.
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Stereotactic Body Radiation Therapy: Undergo SBRT
|
Arm B (Salvage Oligometastasectomy)
n=18 Participants
Patients with nodal metastases undergo salvage oligometastasectomy.
Metastasectomy: Undergo salvage oligometastasectomy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm C (Salvage Oligometastasectomy, Radiation Therapy)
Patients with nodal metastases undergo salvage oligometastasectomy. Following recovery, patients undergo SBRT or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion. Within 4 months following completion of salvage therapy (defined as the combination of oligometastasectomy and/or bone radiation) and depending on PSA response as well as previous treatment, patients may receive adjuvant nodal IMRT.
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Intensity-Modulated Radiation Therapy: Undergo IMRT
Metastasectomy: Undergo salvage oligometastasectomy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Stereotactic Body Radiation Therapy: Undergo SBRT
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AE) by Grade
CTCAE Grade: 1
|
1 Participants
|
11 Participants
|
—
|
|
Number of Participants With Adverse Events (AE) by Grade
CTCAE Grade: 2
|
1 Participants
|
3 Participants
|
—
|
|
Number of Participants With Adverse Events (AE) by Grade
CTCAE Grade: 3
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Adverse Events (AE) by Grade
CTCAE Grade: 4
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Adverse Events (AE) by Grade
CTCAE Grade: 5
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: up to 45 days after the initiation of study therapyPopulation: 1 participant did not complete this assessment in Arm A. 10 participants did not complete this assessment in Arm B. No participants were enrolled in Arm C.
FACT-P is a QOL questionnaires administered at the Response Assessment Visit. FACT-P is used to assess the health-related QOL in prostate cancer. Patients indicate which symptoms/problems they've experienced during the past week, from 1 Not at All to 4 Very Much. The assessment was scored according to the "FACT-P Scoring Guidelines (Version 4)". Individual items that were "reverse items" (high value indicates poor QOL) were subtracted from 4; reverse and normal items were added to calculate each subscale. The higher the subscale the better the QOL. The subscales and score ranges are: Physical Well-Being (0-28), Social/ Family Well Being (0-28), Emotional Well-Being (0-24), Functional Well Being (0-28), and Prostate Cancer Subscale (0-48) This outcome will report the mean score and 95% confidence interval of each subscale.
Outcome measures
| Measure |
Arm A (Radiation Therapy)
n=1 Participants
Patients with bone metastases undergo SBR) or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion.
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Stereotactic Body Radiation Therapy: Undergo SBRT
|
Arm B (Salvage Oligometastasectomy)
n=8 Participants
Patients with nodal metastases undergo salvage oligometastasectomy.
Metastasectomy: Undergo salvage oligometastasectomy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm C (Salvage Oligometastasectomy, Radiation Therapy)
Patients with nodal metastases undergo salvage oligometastasectomy. Following recovery, patients undergo SBRT or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion. Within 4 months following completion of salvage therapy (defined as the combination of oligometastasectomy and/or bone radiation) and depending on PSA response as well as previous treatment, patients may receive adjuvant nodal IMRT.
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Intensity-Modulated Radiation Therapy: Undergo IMRT
Metastasectomy: Undergo salvage oligometastasectomy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Stereotactic Body Radiation Therapy: Undergo SBRT
|
|---|---|---|---|
|
Quality of Life (QOL) - The Functional Assessment of Cancer Therapy - Prostate (FACT-P)
Social/ Family Well Being
|
16 units on a scale
|
24.13 units on a scale
Interval 21.89 to 26.36
|
—
|
|
Quality of Life (QOL) - The Functional Assessment of Cancer Therapy - Prostate (FACT-P)
Emotional Well-Being
|
16 units on a scale
|
19.88 units on a scale
Interval 16.97 to 22.78
|
—
|
|
Quality of Life (QOL) - The Functional Assessment of Cancer Therapy - Prostate (FACT-P)
Functional Well Being
|
14 units on a scale
|
24.50 units on a scale
Interval 21.61 to 27.39
|
—
|
|
Quality of Life (QOL) - The Functional Assessment of Cancer Therapy - Prostate (FACT-P)
Prostate Cancer Subscale
|
41 units on a scale
|
36.50 units on a scale
Interval 32.87 to 40.13
|
—
|
|
Quality of Life (QOL) - The Functional Assessment of Cancer Therapy - Prostate (FACT-P)
Physical Well-Being
|
26 units on a scale
|
25.75 units on a scale
Interval 24.59 to 26.91
|
—
|
SECONDARY outcome
Timeframe: up to 45 days after initiation of study therapyPopulation: 1 participant did not complete this assessment in Arm A. 10 participants did not complete this assessment in Arm B. No participants were enrolled in Arm C.
EPIC-26 is a Health Related Quality of Life (HRQOL) questionnaires assessing the disease-specific aspects of prostate cancer and its therapies. This questionnaire asks patients to rank symptoms from 1 More than once a day to 5 Rarely or never. EPOC-26 reports 5 subscales: Urinary Incontinence Score, Urinary Obstructive/ Irritative Score, Bowel Score, Sexual Score, and Urinary Incontinence Score. Multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL.
Outcome measures
| Measure |
Arm A (Radiation Therapy)
n=1 Participants
Patients with bone metastases undergo SBR) or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion.
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Stereotactic Body Radiation Therapy: Undergo SBRT
|
Arm B (Salvage Oligometastasectomy)
n=8 Participants
Patients with nodal metastases undergo salvage oligometastasectomy.
Metastasectomy: Undergo salvage oligometastasectomy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm C (Salvage Oligometastasectomy, Radiation Therapy)
Patients with nodal metastases undergo salvage oligometastasectomy. Following recovery, patients undergo SBRT or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion. Within 4 months following completion of salvage therapy (defined as the combination of oligometastasectomy and/or bone radiation) and depending on PSA response as well as previous treatment, patients may receive adjuvant nodal IMRT.
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Intensity-Modulated Radiation Therapy: Undergo IMRT
Metastasectomy: Undergo salvage oligometastasectomy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Stereotactic Body Radiation Therapy: Undergo SBRT
|
|---|---|---|---|
|
Quality of Life (QOL): Expanded Prostate Cancer Index Composite (EPIC-26)
EPIC-26: Urinary Incontinence Score
|
46 units on a scale
|
65.22 units on a scale
Interval 51.21 to 79.23
|
—
|
|
Quality of Life (QOL): Expanded Prostate Cancer Index Composite (EPIC-26)
EPIC-26: Urinary Obstructive/ Irritative Score
|
75 units on a scale
|
86.72 units on a scale
Interval 76.51 to 96.93
|
—
|
|
Quality of Life (QOL): Expanded Prostate Cancer Index Composite (EPIC-26)
EPIC-26: Bowel Score
|
100 units on a scale
|
94.27 units on a scale
Interval 89.17 to 99.37
|
—
|
|
Quality of Life (QOL): Expanded Prostate Cancer Index Composite (EPIC-26)
EPIC-26: Sexual Score
|
34.67 units on a scale
|
42.67 units on a scale
Interval 16.06 to 69.27
|
—
|
|
Quality of Life (QOL): Expanded Prostate Cancer Index Composite (EPIC-26)
EPIC-26: Urinary Incontinence Score EPIC-26: Hormonal Score
|
70 units on a scale
|
94.38 units on a scale
Interval 88.69 to 100.06
|
—
|
Adverse Events
Arm A (Radiation Therapy)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Arm B (Salvage Oligometastasectomy)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Arm C (Salvage Oligometastasectomy, Radiation Therapy)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm A (Radiation Therapy)
n=2 participants at risk
Patients with bone metastases undergo SBR) or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion.
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Stereotactic Body Radiation Therapy: Undergo SBRT
|
Arm B (Salvage Oligometastasectomy)
n=18 participants at risk
Patients with nodal metastases undergo salvage oligometastasectomy.
Metastasectomy: Undergo salvage oligometastasectomy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm C (Salvage Oligometastasectomy, Radiation Therapy)
Patients with nodal metastases undergo salvage oligometastasectomy. Following recovery, patients undergo SBRT or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion. Within 4 months following completion of salvage therapy (defined as the combination of oligometastasectomy and/or bone radiation) and depending on PSA response as well as previous treatment, patients may receive adjuvant nodal IMRT.
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Intensity-Modulated Radiation Therapy: Undergo IMRT
Metastasectomy: Undergo salvage oligometastasectomy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Stereotactic Body Radiation Therapy: Undergo SBRT
|
|---|---|---|---|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
0.00%
0/2 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
5.6%
1/18 • Number of events 1 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
—
0/0 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/2 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
11.1%
2/18 • Number of events 2 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
—
0/0 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
5.6%
1/18 • Number of events 1 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
—
0/0 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
50.0%
1/2 • Number of events 1 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
0.00%
0/18 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
—
0/0 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/2 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
11.1%
2/18 • Number of events 2 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
—
0/0 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/2 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
5.6%
1/18 • Number of events 1 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
—
0/0 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
|
General disorders
Edema limbs
|
0.00%
0/2 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
5.6%
1/18 • Number of events 1 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
—
0/0 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/2 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
5.6%
1/18 • Number of events 1 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
—
0/0 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
|
Gastrointestinal disorders
Esophageal hemorrhage
|
0.00%
0/2 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
5.6%
1/18 • Number of events 1 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
—
0/0 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
|
General disorders
Fatigue
|
50.0%
1/2 • Number of events 1 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
11.1%
2/18 • Number of events 2 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
—
0/0 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/2 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
5.6%
1/18 • Number of events 1 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
—
0/0 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/2 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
5.6%
1/18 • Number of events 1 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
—
0/0 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
|
Reproductive system and breast disorders
Genital edema
|
0.00%
0/2 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
11.1%
2/18 • Number of events 2 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
—
0/0 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/2 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
5.6%
1/18 • Number of events 1 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
—
0/0 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/2 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
5.6%
1/18 • Number of events 1 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
—
0/0 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
5.6%
1/18 • Number of events 1 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
—
0/0 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
5.6%
1/18 • Number of events 1 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
—
0/0 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
50.0%
1/2 • Number of events 1 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
5.6%
1/18 • Number of events 1 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
—
0/0 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/2 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
5.6%
1/18 • Number of events 1 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
—
0/0 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
16.7%
3/18 • Number of events 3 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
—
0/0 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/2 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
11.1%
2/18 • Number of events 2 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
—
0/0 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/2 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
5.6%
1/18 • Number of events 1 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
—
0/0 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/2 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
5.6%
1/18 • Number of events 1 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
—
0/0 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
16.7%
3/18 • Number of events 3 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
—
0/0 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
5.6%
1/18 • Number of events 1 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
—
0/0 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/2 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
5.6%
1/18 • Number of events 1 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
—
0/0 • Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
|
Additional Information
IIT Data Management Team
Research Compliance Office, Huntsman Cancer Institute
Phone: 801-213-6215
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place