NCT00528866|CompletedPhase 2ResultsDMC

Radiation Therapy, Androgen Suppression, and Docetaxel in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy

Adjuvant 3DCRT/IMRT in Combination With Androgen Suppression and Docetaxel for High Risk Prostate Cancer Patients Post-Prostatectomy: A Phase II Trial

Radiation Therapy Oncology Group ClinicalTrials.gov

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3 other identifiers

RTOG-0621CDR0000563917NCI-2009-00740

Study Type

interventional

Target

Locations

2 countries

Sites

Timeline

RegisteredSep 2007

StartedApr 2008

CompletionMay 2018

Brief Summary

RATIONALE: Specialized radiation therapy that delivers a high-dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide, goserelin, flutamide, or bicalutamide, may lessen the amount of androgens made by the body. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with androgen suppression and docetaxel after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving radiation therapy together with androgen suppression and docetaxel works in treating patients with high risk prostate cancer who have undergone radical prostatectomy.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Timeline

Completed

Started Apr 2008

Longer than P75 for phase_2 prostate-cancer

Geographic Reach

2 countries

70 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

10.1 years study duration

First Submitted

Initial submission to the registry

September 10, 2007

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 12, 2007

Completed

7 months until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed

5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed

3.5 years until next milestone

Results Posted

Study results publicly available

June 6, 2017

Completed

11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2018

Completed

Last Updated

April 24, 2019

Status Verified

May 1, 2018

Enrollment Period

5.7 years

First QC Date

September 10, 2007

Results QC Date

November 23, 2016

Last Update Submit

April 11, 2019

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostatestage IIB prostate cancerstage IIA prostate cancerstage III prostate cancerstage IV prostate cancer

Outcome Measures

Primary Outcomes (1)

Number of Participants Free From Progression at 3 Years
Failure was defined as PSA ≥ 0.4 ng/mL after the end of radiation therapy confirmed by a second higher PSA, non-protocol hormones, local-regional progression, distant metastasis, or death, within 3 years after study registration. Freedom from progression (FFP) rate under null hypothesis was 50%; under alternative hypothesis ≥ 70%. Per Fleming's multiple testing procedure with 3 stages, 69 patients (76 allowing for 10% ineligible) were required for 90% power and type I error 0.025. If ≥ 44 of 69 patients had a FFP event, we would reject 50% FFP rate in favor of ≥ 70%. Analysis was out of 74 patients (not 69), so ≥ 44 was revised to ≥ 46.
From registration to 3 years.

Secondary Outcomes (9)

Local-regional Progression (3 Year Rate)
Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)
Distant Metastasis (3-year Rate)
Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)
Prostate Cancer Death (3-year Rate)
Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)
Non-prostate Cancer Death (3-year Rate)
Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)
Overall Survival (3-year Rate)
Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)
+4 more secondary outcomes

Study Arms (1)

Androgen suppression + RT + docetaxel

EXPERIMENTAL

LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel

Drug: bicalutamideDrug: docetaxelDrug: flutamideDrug: LHRH agonistRadiation: 3-dimensional conformal radiation therapyRadiation: radiation therapy