Trial Outcomes & Findings for A Study of Definitive Therapy to Treat Prostate Cancer After Prostatectomy (NCT NCT03043807)
NCT ID: NCT03043807
Last Updated: 2023-02-16
Results Overview
To evaluate efficacy of multimodality therapy in men, defined as the 3 year Prostate-specific antigen progression-free (Prostate-specific antigen\<0.2 ng/ml) survival rate among men who have non-castrate testosterone levels 2 years after enrollment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
3 years
Results posted on
2023-02-16
Participant Flow
Participant milestones
| Measure |
Chemohormonal and Definitive Therapy After Prostatectomy
(1st) Systemic chemo-hormonal therapy with up to 6-months (\~24 weeks) of adjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 2 years of androgen deprivation. Androgen blockade (Bicalutamide) will be the same throughout the course of treatment.
Leuprolide Acetate: 22.5mg by intramuscular (IM) injection every 3 months
Docetaxel: 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles. Dose may decreased in the following intervals: 65 mg/M2, 55 mg/M2, 35 mg/M2.
Bicalutamide: bicalutamide (Casodex) 50mg by mouth daily
Radiation: Radiation will be delivered in 1 to 5 fractions, and the dose and fractionation schedule will depend on the size and location of the lesion and the surrounding normal tissue constraints in accordance with AAPM Task Group 101 recommendations. Typical doses include 16 - 24 Gy in 1 fraction, 48 - 50 Gy in 4 fractions, and 50 - 60 Gy in 5 fractions.
Abiraterone Acetate: Abiraterone acetate 1000 mg / day may be given at the investigator's discretion.
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Definitive Therapy to Treat Prostate Cancer After Prostatectomy
Baseline characteristics by cohort
| Measure |
Chemohormonal and Definitive Therapy After Prostatectomy
n=26 Participants
(1st) Systemic chemo-hormonal therapy with up to 6-months (\~24 weeks) of adjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 2 years of androgen deprivation. Androgen blockade (Bicalutamide) will be the same throughout the course of treatment.
Leuprolide Acetate: 22.5mg by intramuscular (IM) injection every 3 months
Docetaxel: 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles. Dose may decreased in the following intervals: 65 mg/M2, 55 mg/M2, 35 mg/M2.
Bicalutamide: bicalutamide (Casodex) 50mg by mouth daily
Radiation: Radiation will be delivered in 1 to 5 fractions, and the dose and fractionation schedule will depend on the size and location of the lesion and the surrounding normal tissue constraints in accordance with AAPM Task Group 101 recommendations. Typical doses include 16 - 24 Gy in 1 fraction, 48 - 50 Gy in 4 fractions, and 50 - 60 Gy in 5 fractions.
Abiraterone Acetate: Abiraterone acetate 1000 mg / day may be given at the investigator's discretion.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
|
Age, Continuous
|
62.2 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: Assessed 25/26 patients (1 patient withdrew from study prior completing TED)
To evaluate efficacy of multimodality therapy in men, defined as the 3 year Prostate-specific antigen progression-free (Prostate-specific antigen\<0.2 ng/ml) survival rate among men who have non-castrate testosterone levels 2 years after enrollment.
Outcome measures
| Measure |
Chemohormonal and Definitive Therapy After Prostatectomy
n=25 Participants
(1st) Systemic chemo-hormonal therapy with up to 6-months (\~24 weeks) of adjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 2 years of androgen deprivation. Androgen blockade (Bicalutamide) will be the same throughout the course of treatment.
Leuprolide Acetate: 22.5mg by intramuscular (IM) injection every 3 months
Docetaxel: 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles. Dose may decreased in the following intervals: 65 mg/M2, 55 mg/M2, 35 mg/M2.
Bicalutamide: bicalutamide (Casodex) 50mg by mouth daily
Radiation: Radiation will be delivered in 1 to 5 fractions, and the dose and fractionation schedule will depend on the size and location of the lesion and the surrounding normal tissue constraints in accordance with AAPM Task Group 101 recommendations. Typical doses include 16 - 24 Gy in 1 fraction, 48 - 50 Gy in 4 fractions, and 50 - 60 Gy in 5 fractions.
Abiraterone Acetate: Abiraterone acetate 1000 mg / day may be given at the investigator's discretion.
|
|---|---|
|
Efficacy as Assessed by 3-year Prostate-specific Antigen Progression-free Survival Rate
3-year Prostate-specific antigen PFS (Prostate-specific antigen <0.2), after enrollment
|
22 Participants
|
|
Efficacy as Assessed by 3-year Prostate-specific Antigen Progression-free Survival Rate
3-year Prostate-specific antigen PFS (Prostate-specific antigen >=0.2), after enrollment
|
3 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Assessed all patients, from time of enrollment until study exit/3 years from enrollment.
To assess the safety of multimodality therapy in men presenting with newly diagnosed oligometastatic prostate cancer after prostatectomy. Toxicities related to neoadjuvant therapy, radiation therapy, or stereotactic body radiation therapy (SBRT) will be assessed using CTCAE version 4 criteria. Surgical toxicities will be assessed using the Clavien-Dindo Classification
Outcome measures
| Measure |
Chemohormonal and Definitive Therapy After Prostatectomy
n=26 Participants
(1st) Systemic chemo-hormonal therapy with up to 6-months (\~24 weeks) of adjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 2 years of androgen deprivation. Androgen blockade (Bicalutamide) will be the same throughout the course of treatment.
Leuprolide Acetate: 22.5mg by intramuscular (IM) injection every 3 months
Docetaxel: 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles. Dose may decreased in the following intervals: 65 mg/M2, 55 mg/M2, 35 mg/M2.
Bicalutamide: bicalutamide (Casodex) 50mg by mouth daily
Radiation: Radiation will be delivered in 1 to 5 fractions, and the dose and fractionation schedule will depend on the size and location of the lesion and the surrounding normal tissue constraints in accordance with AAPM Task Group 101 recommendations. Typical doses include 16 - 24 Gy in 1 fraction, 48 - 50 Gy in 4 fractions, and 50 - 60 Gy in 5 fractions.
Abiraterone Acetate: Abiraterone acetate 1000 mg / day may be given at the investigator's discretion.
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|---|---|
|
Safety of the 3 Years Multimodality Therapy Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 4 Criteria and the Clavien-Dindo Classification
grade 4 neutropenia
|
1 Participants
|
|
Safety of the 3 Years Multimodality Therapy Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 4 Criteria and the Clavien-Dindo Classification
grade 3 neutropenic fever
|
1 Participants
|
|
Safety of the 3 Years Multimodality Therapy Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 4 Criteria and the Clavien-Dindo Classification
No Grades 3 and 4 neutropenia and surgical- or radiation-induced toxicities.
|
24 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Assessed 25/26 patients (1 patient withdrew from study prior completing TED)
To investigate the time from an undetectable Prostate-specific antigen (≤0.2 ng/mL) until the Prostate-specific antigen is \>0.2 over two time-points.
Outcome measures
| Measure |
Chemohormonal and Definitive Therapy After Prostatectomy
n=25 Participants
(1st) Systemic chemo-hormonal therapy with up to 6-months (\~24 weeks) of adjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 2 years of androgen deprivation. Androgen blockade (Bicalutamide) will be the same throughout the course of treatment.
Leuprolide Acetate: 22.5mg by intramuscular (IM) injection every 3 months
Docetaxel: 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles. Dose may decreased in the following intervals: 65 mg/M2, 55 mg/M2, 35 mg/M2.
Bicalutamide: bicalutamide (Casodex) 50mg by mouth daily
Radiation: Radiation will be delivered in 1 to 5 fractions, and the dose and fractionation schedule will depend on the size and location of the lesion and the surrounding normal tissue constraints in accordance with AAPM Task Group 101 recommendations. Typical doses include 16 - 24 Gy in 1 fraction, 48 - 50 Gy in 4 fractions, and 50 - 60 Gy in 5 fractions.
Abiraterone Acetate: Abiraterone acetate 1000 mg / day may be given at the investigator's discretion.
|
|---|---|
|
Time to Prostate-specific Antigen Recurrence
|
NA Month
The median time to PSA (Prostate-specific antigen) recurrence within 3 years was not reached because at that timepoint, less than 50% of the participants had experienced a PSA recurrence.
|
Adverse Events
Chemohormonal and Definitive Therapy After Prostatectomy
Serious events: 2 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chemohormonal and Definitive Therapy After Prostatectomy
n=26 participants at risk
(1st) Systemic chemo-hormonal therapy with up to 6-months (\~24 weeks) of adjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 2 years of androgen deprivation. Androgen blockade (Bicalutamide) will be the same throughout the course of treatment.
Leuprolide Acetate: 22.5mg by intramuscular (IM) injection every 3 months
Docetaxel: 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles. Dose may decreased in the following intervals: 65 mg/M2, 55 mg/M2, 35 mg/M2.
Bicalutamide: bicalutamide (Casodex) 50mg by mouth daily
Radiation: Radiation will be delivered in 1 to 5 fractions, and the dose and fractionation schedule will depend on the size and location of the lesion and the surrounding normal tissue constraints in accordance with AAPM Task Group 101 recommendations. Typical doses include 16 - 24 Gy in 1 fraction, 48 - 50 Gy in 4 fractions, and 50 - 60 Gy in 5 fractions.
Abiraterone Acetate: Abiraterone acetate 1000 mg / day may be given at the investigator's discretion.
|
|---|---|
|
Blood and lymphatic system disorders
neutropenia
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
|
General disorders
neutropenic fever
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
Other adverse events
| Measure |
Chemohormonal and Definitive Therapy After Prostatectomy
n=26 participants at risk
(1st) Systemic chemo-hormonal therapy with up to 6-months (\~24 weeks) of adjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 2 years of androgen deprivation. Androgen blockade (Bicalutamide) will be the same throughout the course of treatment.
Leuprolide Acetate: 22.5mg by intramuscular (IM) injection every 3 months
Docetaxel: 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles. Dose may decreased in the following intervals: 65 mg/M2, 55 mg/M2, 35 mg/M2.
Bicalutamide: bicalutamide (Casodex) 50mg by mouth daily
Radiation: Radiation will be delivered in 1 to 5 fractions, and the dose and fractionation schedule will depend on the size and location of the lesion and the surrounding normal tissue constraints in accordance with AAPM Task Group 101 recommendations. Typical doses include 16 - 24 Gy in 1 fraction, 48 - 50 Gy in 4 fractions, and 50 - 60 Gy in 5 fractions.
Abiraterone Acetate: Abiraterone acetate 1000 mg / day may be given at the investigator's discretion.
|
|---|---|
|
General disorders
fatigue
|
80.8%
21/26 • Number of events 21 • Up to 3 years
|
|
Vascular disorders
hot flashes
|
38.5%
10/26 • Number of events 10 • Up to 3 years
|
|
Nervous system disorders
neuropathy
|
38.5%
10/26 • Number of events 10 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
alopecia;
|
19.2%
5/26 • Number of events 5 • Up to 3 years
|
|
Nervous system disorders
dysgeusia
|
19.2%
5/26 • Number of events 5 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
hiccups
|
15.4%
4/26 • Number of events 4 • Up to 3 years
|
|
Gastrointestinal disorders
nausea
|
15.4%
4/26 • Number of events 4 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
skin alterations
|
15.4%
4/26 • Number of events 4 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
xerosis
|
7.7%
2/26 • Number of events 2 • Up to 3 years
|
|
Psychiatric disorders
anxiety
|
7.7%
2/26 • Number of events 2 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
edema (lower extremity)
|
11.5%
3/26 • Number of events 3 • Up to 3 years
|
|
Gastrointestinal disorders
gastritis
|
11.5%
3/26 • Number of events 3 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
rash
|
11.5%
3/26 • Number of events 3 • Up to 3 years
|
|
Gastrointestinal disorders
constipation
|
11.5%
3/26 • Number of events 3 • Up to 3 years
|
|
Gastrointestinal disorders
gastrointestinal reflux
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
pain (bilateral legs)
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
|
Gastrointestinal disorders
mucositis
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
pain (joint);
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
|
Metabolism and nutrition disorders
anorexia
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
nail ridging
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
|
Investigations
weight gain
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
|
Renal and urinary disorders
hematuria
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
|
Renal and urinary disorders
urinary tract obstruction
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
|
Gastrointestinal disorders
oral candidiasis
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
|
Psychiatric disorders
insomnia
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
|
Psychiatric disorders
depression
|
3.8%
1/26 • Number of events 2 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
arthritis
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
pain (pelvis)
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
|
Nervous system disorders
memory impairment
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
|
Gastrointestinal disorders
heartburn
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
|
Investigations
elevated ALT
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
|
Investigations
elevated AST
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
|
Gastrointestinal disorders
hematochezia
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
|
Gastrointestinal disorders
xerostomia
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
|
Blood and lymphatic system disorders
anemia
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
general body aches
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
pruritis
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
|
Investigations
epistaxis
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
infusion related reaction
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
nail discoloration
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
|
General disorders
fever
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
|
Gastrointestinal disorders
diarrhea
|
11.5%
3/26 • Number of events 3 • Up to 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place