Trial Outcomes & Findings for Stereotactic Body Radiation for Prostate Oligometastases (NCT NCT02680587)
NCT ID: NCT02680587
Last Updated: 2022-11-29
Results Overview
Number of participants who progressed at 6 months. Progression is defined as either: 1) a ≥ 25% increase in PSA from nadir (and by ≥ 2 ng/mL), requiring confirmation ≥ 4 weeks later (PCWG2 criteria); and/or, 2) clinical/radiographic-progression defined as symptomatic progression (worsening disease-related symptoms or new cancer-related complications), or radiologic progression (on CT scan: ≥ 20% enlargement in sum diameter of soft-tissue target lesions \[RECIST1.1 criteria\]; on bone scan: ≥ 1 new bone lesions),initiation of ADT or death due to any cause, whichever occurs first.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
6 months
Results posted on
2022-11-29
Participant Flow
26 Excluded from 80, these are: 19 Did not meet inclusion criteria; 5 Declined to participate; 2 Insurance denied
Participant milestones
| Measure |
Observational (no SBRT)
Evaluating men with oligometastatic prostate cancer lesions randomized to observation
Observational (no SBRT): These patient will not receive SBRT. They will be observed.
|
SBRT
Evaluating men with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT).
SBRT: SBRT (1-5 fractions) will be administered.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
36
|
|
Overall Study
COMPLETED
|
17
|
36
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Observational (no SBRT)
Evaluating men with oligometastatic prostate cancer lesions randomized to observation
Observational (no SBRT): These patient will not receive SBRT. They will be observed.
|
SBRT
Evaluating men with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT).
SBRT: SBRT (1-5 fractions) will be administered.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Observational (no SBRT)
n=18 Participants
Evaluating males with oligometastatic prostate cancer lesions randomized to observation
Observational (no SBRT): These patients will not receive SBRT. They will be observed.
|
SBRT
n=36 Participants
Evaluating males with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT).
SBRT: SBRT (1-5 fractions) will be administered.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 Years
n=18 Participants
|
68 Years
n=36 Participants
|
68 Years
n=54 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=18 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=54 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=18 Participants
|
36 Participants
n=36 Participants
|
54 Participants
n=54 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
18 Participants
n=18 Participants
|
36 Participants
n=36 Participants
|
54 Participants
n=54 Participants
|
|
Initial T stage (extent of the tumor)
cT1c
|
1 Participants
n=18 Participants
|
3 Participants
n=36 Participants
|
4 Participants
n=54 Participants
|
|
Initial T stage (extent of the tumor)
cT2a
|
0 Participants
n=18 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=54 Participants
|
|
Initial T stage (extent of the tumor)
cT2b
|
1 Participants
n=18 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=54 Participants
|
|
Initial T stage (extent of the tumor)
cT3a
|
1 Participants
n=18 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=54 Participants
|
|
Initial T stage (extent of the tumor)
pT2
|
6 Participants
n=18 Participants
|
12 Participants
n=36 Participants
|
18 Participants
n=54 Participants
|
|
Initial T stage (extent of the tumor)
pT3a
|
8 Participants
n=18 Participants
|
10 Participants
n=36 Participants
|
18 Participants
n=54 Participants
|
|
Initial T stage (extent of the tumor)
pT3b
|
1 Participants
n=18 Participants
|
8 Participants
n=36 Participants
|
9 Participants
n=54 Participants
|
|
Initial N stage (extent of spread to the lymph nodes
N0
|
16 Participants
n=18 Participants
|
31 Participants
n=36 Participants
|
47 Participants
n=54 Participants
|
|
Initial N stage (extent of spread to the lymph nodes
N1
|
1 Participants
n=18 Participants
|
2 Participants
n=36 Participants
|
3 Participants
n=54 Participants
|
|
Initial N stage (extent of spread to the lymph nodes
NX
|
1 Participants
n=18 Participants
|
3 Participants
n=36 Participants
|
4 Participants
n=54 Participants
|
|
Tumor margin status
R0
|
10 Participants
n=18 Participants
|
20 Participants
n=36 Participants
|
30 Participants
n=54 Participants
|
|
Tumor margin status
R1
|
5 Participants
n=18 Participants
|
10 Participants
n=36 Participants
|
15 Participants
n=54 Participants
|
|
Tumor margin status
Not applicable
|
3 Participants
n=18 Participants
|
6 Participants
n=36 Participants
|
9 Participants
n=54 Participants
|
|
Gleason score
3+3=6
|
0 Participants
n=18 Participants
|
3 Participants
n=36 Participants
|
3 Participants
n=54 Participants
|
|
Gleason score
3+4=7
|
4 Participants
n=18 Participants
|
8 Participants
n=36 Participants
|
12 Participants
n=54 Participants
|
|
Gleason score
4+3=7
|
4 Participants
n=18 Participants
|
14 Participants
n=36 Participants
|
18 Participants
n=54 Participants
|
|
Gleason score
4+4=8
|
1 Participants
n=18 Participants
|
4 Participants
n=36 Participants
|
5 Participants
n=54 Participants
|
|
Gleason score
4+5=9
|
8 Participants
n=18 Participants
|
4 Participants
n=36 Participants
|
12 Participants
n=54 Participants
|
|
Gleason score
5+4=9
|
0 Participants
n=18 Participants
|
3 Participants
n=36 Participants
|
3 Participants
n=54 Participants
|
|
Gleason score
5+5=10
|
1 Participants
n=18 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=54 Participants
|
|
Initial management
Surgery
|
15 Participants
n=18 Participants
|
30 Participants
n=36 Participants
|
45 Participants
n=54 Participants
|
|
Initial management
Radiotherapy
|
3 Participants
n=18 Participants
|
6 Participants
n=36 Participants
|
9 Participants
n=54 Participants
|
|
Time to first recurrence
|
22 month
n=18 Participants
|
22 month
n=36 Participants
|
22 month
n=54 Participants
|
|
Had received prior ADT
|
5 Participants
n=18 Participants
|
28 Participants
n=36 Participants
|
33 Participants
n=54 Participants
|
|
Baseline prostate-specific antigen (PSA)
|
7 ng/dl
n=18 Participants
|
6 ng/dl
n=36 Participants
|
6 ng/dl
n=54 Participants
|
|
Baseline prostate-specific antigen doubling time (PSADT)
|
6 months
n=18 Participants
|
8 months
n=36 Participants
|
8 months
n=54 Participants
|
PRIMARY outcome
Timeframe: 6 monthsNumber of participants who progressed at 6 months. Progression is defined as either: 1) a ≥ 25% increase in PSA from nadir (and by ≥ 2 ng/mL), requiring confirmation ≥ 4 weeks later (PCWG2 criteria); and/or, 2) clinical/radiographic-progression defined as symptomatic progression (worsening disease-related symptoms or new cancer-related complications), or radiologic progression (on CT scan: ≥ 20% enlargement in sum diameter of soft-tissue target lesions \[RECIST1.1 criteria\]; on bone scan: ≥ 1 new bone lesions),initiation of ADT or death due to any cause, whichever occurs first.
Outcome measures
| Measure |
Observational (no SBRT)
n=18 Participants
Evaluating men with oligometastatic prostate cancer lesions randomized to observation
Observational (no SBRT): These patient will not receive SBRT. They will be observed.
|
SBRT
n=36 Participants
Evaluating men with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT).
SBRT: SBRT (1-5 fractions) will be administered.
|
|---|---|---|
|
Progression at 6 Months
|
11 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: up to 6 monthsNumber of months until local progression in patients with oligometastatic disease.
Outcome measures
| Measure |
Observational (no SBRT)
n=18 Participants
Evaluating men with oligometastatic prostate cancer lesions randomized to observation
Observational (no SBRT): These patient will not receive SBRT. They will be observed.
|
SBRT
n=36 Participants
Evaluating men with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT).
SBRT: SBRT (1-5 fractions) will be administered.
|
|---|---|---|
|
Time to Local Progression
|
5.8 Months
Interval 1.0 to 6.0
|
6 Months
Interval 3.0 to 6.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data for this outcome measure was not collected from the Observation arm.
Number of lesions that did not increase in size by at least 20% or more on CT from baseline to 6 months.
Outcome measures
| Measure |
Observational (no SBRT)
Evaluating men with oligometastatic prostate cancer lesions randomized to observation
Observational (no SBRT): These patient will not receive SBRT. They will be observed.
|
SBRT
n=89 lesions
Evaluating men with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT).
SBRT: SBRT (1-5 fractions) will be administered.
|
|---|---|---|
|
Local Control of SBRT Group
|
—
|
89 lesions
|
SECONDARY outcome
Timeframe: up to 6 monthsNumber of participants experiencing adverse events Grade 3 or higher, as defined by CTCAE.
Outcome measures
| Measure |
Observational (no SBRT)
n=18 Participants
Evaluating men with oligometastatic prostate cancer lesions randomized to observation
Observational (no SBRT): These patient will not receive SBRT. They will be observed.
|
SBRT
n=36 Participants
Evaluating men with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT).
SBRT: SBRT (1-5 fractions) will be administered.
|
|---|---|---|
|
Toxicity as Assessed by Number of Participants With Adverse Events Grade 3 or Higher
3 months
|
0 participants
|
0 participants
|
|
Toxicity as Assessed by Number of Participants With Adverse Events Grade 3 or Higher
6 months
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: up to 6 monthsPopulation: 2 from observation group discontinued intervention because of progression prior to 90 days.
Number of participants experiencing adverse events Grades 1 or 2, as defined by CTCAE
Outcome measures
| Measure |
Observational (no SBRT)
n=16 Participants
Evaluating men with oligometastatic prostate cancer lesions randomized to observation
Observational (no SBRT): These patient will not receive SBRT. They will be observed.
|
SBRT
n=36 Participants
Evaluating men with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT).
SBRT: SBRT (1-5 fractions) will be administered.
|
|---|---|---|
|
Toxicity as Assessed by Number of Participants With Adverse Events Grades 1 or 2
3 month
|
11 participants
|
30 participants
|
|
Toxicity as Assessed by Number of Participants With Adverse Events Grades 1 or 2
6 month
|
3 participants
|
15 participants
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsWe will assess quality of life following completion of Stereotactic Body Radiation Therapy via Brief Pain Inventory questionnaire made up of 9 questions. Each question scores from 0-10, with higher scores mean worse outcome or more pain. An overall score, calculated by adding the scores for questions 2, 3, 4 and 5 and then dividing by 4, will be calculated pre-treatment and at the time of day 180. The change in score (between baseline and 6 months) will be evaluated.
Outcome measures
| Measure |
Observational (no SBRT)
n=18 Participants
Evaluating men with oligometastatic prostate cancer lesions randomized to observation
Observational (no SBRT): These patient will not receive SBRT. They will be observed.
|
SBRT
n=36 Participants
Evaluating men with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT).
SBRT: SBRT (1-5 fractions) will be administered.
|
|---|---|---|
|
Change in Quality of Life as Assessed by Brief Pain Inventory
|
0 score on a scale
Interval 0.0 to 0.25
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data was not collected for this outcome measure
18F-DCFPyL Positron Emission Tomography (PET)/MRI or -PET/CT positive sites that are positive for new or progressive metastatic disease by bone scan/CT at 6-months following SBRT.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Data was not collected
The PSA levels in blood will be measured in units of nanograms per milliliter (ng/mL).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthAndrogen Deprivation Therapy-free survival will be assessed using the number of participants deceased at 6 months.
Outcome measures
| Measure |
Observational (no SBRT)
n=18 Participants
Evaluating men with oligometastatic prostate cancer lesions randomized to observation
Observational (no SBRT): These patient will not receive SBRT. They will be observed.
|
SBRT
n=36 Participants
Evaluating men with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT).
SBRT: SBRT (1-5 fractions) will be administered.
|
|---|---|---|
|
Androgen Deprivation Therapy-free Survival
|
0 Participants
|
0 Participants
|
Adverse Events
Observational (no SBRT)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
SBRT
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Observational (no SBRT)
n=18 participants at risk
Evaluating men with oligometastatic prostate cancer lesions randomized to observation
Observational (no SBRT): These patient will not receive SBRT. They will be observed.
|
SBRT
n=36 participants at risk
Evaluating men with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT).
SBRT: SBRT (1-5 fractions) will be administered.
|
|---|---|---|
|
Renal and urinary disorders
Urinary Incontinence
|
11.1%
2/18 • Number of events 2 • up to 6 months
|
5.6%
2/36 • Number of events 2 • up to 6 months
|
|
General disorders
Fatigue
|
5.6%
1/18 • Number of events 1 • up to 6 months
|
13.9%
5/36 • Number of events 5 • up to 6 months
|
|
General disorders
Anorexia
|
5.6%
1/18 • Number of events 1 • up to 6 months
|
0.00%
0/36 • up to 6 months
|
|
Skin and subcutaneous tissue disorders
Bruising
|
11.1%
2/18 • Number of events 2 • up to 6 months
|
0.00%
0/36 • up to 6 months
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/18 • up to 6 months
|
2.8%
1/36 • Number of events 1 • up to 6 months
|
|
Psychiatric disorders
Depression
|
5.6%
1/18 • Number of events 1 • up to 6 months
|
0.00%
0/36 • up to 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/18 • up to 6 months
|
8.3%
3/36 • Number of events 3 • up to 6 months
|
|
General disorders
Weight loss
|
0.00%
0/18 • up to 6 months
|
2.8%
1/36 • Number of events 1 • up to 6 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/18 • up to 6 months
|
5.6%
2/36 • Number of events 2 • up to 6 months
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/18 • up to 6 months
|
2.8%
1/36 • Number of events 1 • up to 6 months
|
|
General disorders
Weight gain
|
0.00%
0/18 • up to 6 months
|
2.8%
1/36 • Number of events 1 • up to 6 months
|
|
General disorders
Dry mouth
|
0.00%
0/18 • up to 6 months
|
2.8%
1/36 • Number of events 1 • up to 6 months
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/18 • up to 6 months
|
2.8%
1/36 • Number of events 1 • up to 6 months
|
|
Gastrointestinal disorders
Esophageal pain
|
0.00%
0/18 • up to 6 months
|
2.8%
1/36 • Number of events 1 • up to 6 months
|
|
Gastrointestinal disorders
Perineal pain
|
0.00%
0/18 • up to 6 months
|
2.8%
1/36 • Number of events 1 • up to 6 months
|
|
General disorders
Insomnia
|
0.00%
0/18 • up to 6 months
|
2.8%
1/36 • Number of events 1 • up to 6 months
|
|
Renal and urinary disorders
Bladder infection
|
0.00%
0/18 • up to 6 months
|
2.8%
1/36 • Number of events 1 • up to 6 months
|
|
Psychiatric disorders
Anxiety
|
5.6%
1/18 • Number of events 1 • up to 6 months
|
5.6%
2/36 • Number of events 2 • up to 6 months
|
|
Renal and urinary disorders
Urinary Retention
|
5.6%
1/18 • Number of events 1 • up to 6 months
|
2.8%
1/36 • Number of events 1 • up to 6 months
|
|
General disorders
Localized Edema
|
5.6%
1/18 • Number of events 1 • up to 6 months
|
5.6%
2/36 • Number of events 2 • up to 6 months
|
|
General disorders
Tremor
|
5.6%
1/18 • Number of events 1 • up to 6 months
|
0.00%
0/36 • up to 6 months
|
|
Gastrointestinal disorders
Pruritis
|
5.6%
1/18 • Number of events 1 • up to 6 months
|
0.00%
0/36 • up to 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/18 • up to 6 months
|
5.6%
2/36 • Number of events 2 • up to 6 months
|
|
General disorders
Weight Loss
|
0.00%
0/18 • up to 6 months
|
5.6%
2/36 • Number of events 2 • up to 6 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/18 • up to 6 months
|
2.8%
1/36 • Number of events 1 • up to 6 months
|
|
General disorders
Anemia
|
0.00%
0/18 • up to 6 months
|
2.8%
1/36 • Number of events 1 • up to 6 months
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/18 • up to 6 months
|
2.8%
1/36 • Number of events 1 • up to 6 months
|
|
General disorders
Dizziness
|
0.00%
0/18 • up to 6 months
|
2.8%
1/36 • Number of events 1 • up to 6 months
|
|
General disorders
Dehydration
|
0.00%
0/18 • up to 6 months
|
2.8%
1/36 • Number of events 1 • up to 6 months
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/18 • up to 6 months
|
2.8%
1/36 • Number of events 1 • up to 6 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/18 • up to 6 months
|
2.8%
1/36 • Number of events 1 • up to 6 months
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/18 • up to 6 months
|
2.8%
1/36 • Number of events 1 • up to 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place