Trial Outcomes & Findings for External Beam Radiation With or Without Chemotherapy to Treat High Risk Prostate Cancer (NCT NCT01603420)

Results Overview

Measurement of Freedom from Failure i.e. the first occurence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (Prostate Specific Antigen \[PSA\] \> = 2 ng/ml over the nadir PSA discounting bounces per the investigators discretion), or the start of salvage therapy including androgen deprivation. This study was terminated prior to the time frame of 2 years being reached. Therefore, this outcome was assessed at time of study closure (22 months).

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

2 participants

Primary outcome timeframe

No failures were reported at the time of study termination (22 months). This outcome was originally written to assess failure at 2 years. However, that end point was not reached.

Results posted on

2016-03-14

Participant Flow

Participant milestones

Participant milestones
Measure	Radiation + 24mo LHRH Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression). LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin. Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).	Radiation + Chemo + 6mo LHRH Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression). Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks. Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).
Overall Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

External Beam Radiation With or Without Chemotherapy to Treat High Risk Prostate Cancer

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: No failures were reported at the time of study termination (22 months). This outcome was originally written to assess failure at 2 years. However, that end point was not reached.

Population: No failures were reported at the time of study termination (22 months). This outcome was originally written to assess failure at 2 years. However, that end point was not reached.

Measurement of Freedom from Failure i.e. the first occurence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (Prostate Specific Antigen \[PSA\] \> = 2 ng/ml over the nadir PSA discounting bounces per the investigators discretion), or the start of salvage therapy including androgen deprivation. This study was terminated prior to the time frame of 2 years being reached. Therefore, this outcome was assessed at time of study closure (22 months).

Outcome measures

Outcome measures
Measure	Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH) n=1 Participants Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression). Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin. Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).	Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone n=1 Participants Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression). Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin. Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks. Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).
Phase 2 - Assessment of Number of Freedom From Failure Events in the Chemotherapy Arm	0 failure events	0 failure events

PRIMARY outcome

Timeframe: at 5 years

This endpoint will be examined if decision is made to not move forward with phase 3 study. This study was terminated prior to a decision being made about moving on to a phase 3 study. Therefore, this outcome was not assessed.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 2 years

Population: This study was terminated prior to the time frame of 2 years being reached. Therefore, this outcome was assessed at time of study closure (22 months).

Assessment will be performed using CTCAE v4 criteria. This study was terminated prior to the time frame of 2 years being reached. Therefore, this outcome was assessed at time of study closure (22 months).

Outcome measures

Outcome measures
Measure	Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH) n=1 Participants Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression). Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin. Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).	Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone n=1 Participants Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression). Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin. Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks. Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).
Phase 2 - Cumulative Number of Incidences of Grade 3 or Higher Adverse Events.	0 events	0 events

PRIMARY outcome

Timeframe: at 5 years

Population: This study was terminated prior to a decision being made about moving on to a phase 3 study. Therefore, this outcome was not assessed.

The events for FFF will be the first occurence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (PSA \> = ng/ml over the nadir PSA discounting bounces per the investigators discretion), or the start of salvage androgen deprivation. This study was terminated prior to a decision being made about moving on to a phase 3 study. Therefore, this outcome was not assessed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at 6 months

Assessment will be performed using CTCAE v 4 criteria.

Outcome measures

Outcome measures
Measure	Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH) n=1 Participants Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression). Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin. Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).	Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone n=1 Participants Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression). Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin. Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks. Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).
Assessment of Number of Grade 2 or Higher Genitourinary (GU) and Gastrointestinal (GI) Adverse Events	0 incidences	1 incidences

SECONDARY outcome

Timeframe: at 3 years

Descriptive measurements of frequency will be compiled. This study was terminated prior to the time frame of 3 years being reached. Therefore, this outcome was not assessed. Data were collected on toxicities up until study closure at 22 months. However, this timepoint was not indicated as a secondary objective in the protocol. Therefore, data was not analyzed at time of study closure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at time of study closure (22 months)

The total number of local/distant failures will be assessed.

Outcome measures

Outcome measures
Measure	Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH) n=1 Participants Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression). Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin. Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).	Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone n=1 Participants Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression). Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin. Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks. Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).
Assessment of Total Number of Local/Distant Failures	0 participants	0 participants

SECONDARY outcome

Timeframe: Up to 10 years

Population: unable to assess due to study termination

unable to assess due to lack of data

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At study closure (22 months)

The total number of subjects with salvage androgen deprivation use will be assessed.

Outcome measures

Outcome measures
Measure	Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH) n=1 Participants Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression). Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin. Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).	Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone n=1 Participants Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression). Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin. Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks. Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).
Assessment of Total Number of Salvage Androgen Deprivation Use With Comparison of Arms.	0 participants	0 participants

SECONDARY outcome

Timeframe: at study closure (22 months)

The number of deaths in both arms will be assessed.

Outcome measures

Outcome measures
Measure	Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH) n=1 Participants Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression). Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin. Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).	Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone n=1 Participants Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression). Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin. Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks. Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).
Assessment of Total Number of Survival Events With Comparison of Group Arms	0 participants	0 participants

SECONDARY outcome

Timeframe: at study closure (22 months)

The number of biochemical failure events will be assessed on both arms.

Outcome measures

Outcome measures
Measure	Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH) n=1 Participants Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression). Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin. Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).	Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone n=1 Participants Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression). Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin. Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks. Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).
Assessment of Total Number of Biochemical Failure Events	0 participants	0 participants

SECONDARY outcome

Timeframe: Up to 10 years

Population: unable to assess due to study termination

unable to assess due to lack of data

Outcome measures

Outcome data not reported

Adverse Events

Radiation + 24mo LHRH

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Radiation + Chemo + 6mo LHRH

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Radiation + 24mo LHRH n=1 participants at risk Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression). LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin. Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).	Radiation + Chemo + 6mo LHRH n=1 participants at risk Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression). Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks. Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).
Renal and urinary disorders urinary retention	100.0% 1/1 • Number of events 1	0.00% 0/1
Psychiatric disorders agitation	100.0% 1/1 • Number of events 1	0.00% 0/1
General disorders fatigue	100.0% 1/1 • Number of events 1	0.00% 0/1
Vascular disorders hot flashes	100.0% 1/1 • Number of events 1	0.00% 0/1
Skin and subcutaneous tissue disorders dermatitis radiation	100.0% 1/1 • Number of events 1	100.0% 1/1 • Number of events 1
Renal and urinary disorders urinary incontinence	100.0% 1/1 • Number of events 1	100.0% 1/1 • Number of events 1
Renal and urinary disorders urinary tract pain	0.00% 0/1	100.0% 1/1 • Number of events 1
Renal and urinary disorders hematuria	0.00% 0/1	100.0% 1/1 • Number of events 1
Gastrointestinal disorders diarrhea	0.00% 0/1	100.0% 1/1 • Number of events 1

Additional Information

Corey Woods

The Proton Collaborative Group

Phone: 630-836-8668

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Radiation + 24mo LHRH n=1 Participants Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression). LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin. Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).	Radiation + Chemo + 6mo LHRH n=1 Participants Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression). Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks. Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	53 years n=5 Participants	72 years n=7 Participants	62.5 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants