NCT01368588|Active Not RecruitingPhase 3ResultsDMC

Androgen-Deprivation Therapy and Radiation Therapy in Treating Patients With Prostate Cancer

Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial

Radiation Therapy Oncology Group ClinicalTrials.gov

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3 other identifiers

RTOG-0924CDR0000701128NCI-2011-02674

Study Type

interventional

Target

2,590

Locations

6 countries

Sites

478

Timeline

RegisteredJun 2011

StartedJul 2011

CompletionJul 2031

Brief Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells. PURPOSE: This randomized phase III trial studies androgen-deprivation therapy and radiation therapy in treating patients with prostate cancer.

Trial Health

On Track

Trial Health Score

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

Enrollment

2,590

participants targeted

Target at P75+ for phase_3 prostate-cancer

Timeline

63mo left

Started Jul 2011

Longer than P75 for phase_3 prostate-cancer

Geographic Reach

6 countries

478 active sites

Status

active not recruiting

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

20 years study duration

Study Progress74%

Jul 2011Jul 2031

First Submitted

Initial submission to the registry

June 7, 2011

Completed

1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2011

Completed

23 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed

13.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2025

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

May 8, 2026

Completed

5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2031

Expected

Last Updated

May 8, 2026

Status Verified

April 1, 2026

Enrollment Period

13.8 years

First QC Date

June 7, 2011

Results QC Date

April 16, 2026

Last Update Submit

April 16, 2026

Conditions

Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

Percentage of Participants Alive (Overall Survival)
Survival rates are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis.
From randomization to death or last follow-up. Median follow-up at time of analysis was 6.8 years. Five- and ten-year estimates are reported.

Secondary Outcomes (9)

Percent of Participants Who Died Due to Prostate Cancer
From randomization to death due to prostate cancer or last follow-up. Median follow-up at time of analysis was 6.8 years. Five- and ten-year estimates are reported.
Percentage of Participants With Distant Metastasis
From date of randomization to distant metastasis, death, or last follow-up, whichever occurs first. Median follow-up at time of analysis was 6.8 years. Five- and ten-year estimates are reported.
Percentage of Participants With Biochemical Failure
From date of randomization to the date of biochemical failure, death, or last follow-up, whichever occurs first. Median follow-up at time of analysis was 6.8 years. Five- and ten-year estimates are reported.
Number of Participants by Highest Grade Acute Adverse Event Reported
From protocol treatment start date to 30 days from completion of radiation therapy. RT begins approximately weeks 8-10 after starting protocol therapy and ends approximately weeks 19-22, depending on boost technique.
Number of Participants by Highest Grade Late Adverse Event Reported
From 30 days after completion of radiation therapy (approximately weeks 19-22, depending on boost technique) to highest grade late adverse event. Median follow-up at time of analysis was 6.7 years.
+4 more secondary outcomes

Study Arms (2)

Prostate/Seminal Vesicle Radiotherapy + ADT + Prostate Boost (Arm 1)

ACTIVE COMPARATOR

Participants receive androgen deprivation therapy (ADT), consisting of an oral anti androgen plus a luteinizing hormone-releasing hormone (LHRH) agonist or antagonist, for a total duration of 4, 6, or 32 months. Approximately 8-10 weeks after starting the LHRH agent, participants undergo external beam radiation therapy (EBRT) to the prostate and entire seminal vesicles, delivered as 45 Gy in 25 fractions using three-dimensional conformal radiotherapy (3D CRT) or intensity modulated radiotherapy (IMRT). A boost to the prostate and proximal seminal vesicles follows, using either IMRT (34.2 Gy in 19 fractions, with protocol specified dose reduction options when indicated) or brachytherapy delivered as low dose rate (LDR) or high dose rate (HDR) implant per protocol.

Radiation: three-dimensional conformal radiotherapyRadiation: intensity modulated radiotherapyRadiation: BrachytherapyDrug: Anti-androgenDrug: luteinizing hormone-releasing hormone (LHRH) agonist or antagonist

Whole Pelvic Radiotherapy + ADT + Prostate Boost (Arm 2)

EXPERIMENTAL

Participants receive ADT as in Arm 1. Approximately 8-10 weeks after starting the LHRH agent, participants undergo external beam radiation therapy (EBRT) to the whole pelvis-including prostate, seminal vesicles, and pelvic lymph nodes-delivered as 45 Gy in 25 fractions using three-dimensional conformal radiotherapy (3D CRT) or intensity modulated radiotherapy (IMRT). A boost is then administered as specified for Arm 1.