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Radiation Therapy

Radiation Therapy + Androgen Deprivation for Prostate Cancer

Phase 3
Waitlist Available
Led By Alan Pollack, MD, PhD
Research Sponsored by Radiation Therapy Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
One of the following pathologic classifications: T3N0/Nx disease with or without a positive prostatectomy surgical margin; or T2N0/Nx disease with or without a positive prostatectomy surgical margin; Prostatectomy Gleason score of 9 or less; Zubrod Performance Status of 0-1; Age ≥ 18
No distant metastases, based upon specific diagnostic workup criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to last follow-up. maximum follow-up at time of analysis was 10.5 years.
Awards & highlights

Study Summary

This trial is comparing different regimens of radiation therapy with or without androgen-deprivation therapy for prostate cancer.

Who is the study for?
Men aged 18+ who've had prostate surgery for adenocarcinoma of the prostate with no lymph node involvement or unknown status, a PSA level between 0.1 and <2.0 ng/mL post-surgery, and a Gleason score ≤9. They must not have distant metastases, prior pelvic radiotherapy, other recent cancers except certain skin cancers, severe co-morbidities like heart failure or inflammatory bowel disease, HIV/AIDS, or previous allergic reactions to study drugs.Check my eligibility
What is being tested?
This phase III trial is testing whether radiation therapy alone is as effective as combining it with short-term hormone therapy in treating men whose PSA levels are rising after prostate cancer surgery. It compares pelvic lymph node radiation with/without prostate radiation against androgen deprivation therapy plus pelvic lymph node radiation.See study design
What are the potential side effects?
Radiation may cause fatigue, skin changes at the treatment site, urinary issues like increased frequency or discomfort during urination; bowel problems such as diarrhea; erectile dysfunction. Hormone therapy can lead to hot flashes, reduced sex drive and energy levels; potential bone thinning over time.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has not spread to distant parts of my body.
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My prostate cancer was treated with surgery and either no lymph nodes were affected or their status is unknown.
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My PSA levels are between 0.1 and 2.0 ng/mL after my prostate surgery.
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My testosterone levels are within the normal range.
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My bone marrow is functioning well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to last follow-up. maximum follow-up at time of analysis was 10.5 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to last follow-up. maximum follow-up at time of analysis was 10.5 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Free From Progression (FFP) at 5 Years
Secondary outcome measures
Assessment and Comparison of Quality Adjusted Life Year (QALY) and Quality Adjusted FFP Year (QAFFPY)
Assessment of Mood and Depression Change Using QOL Measured by the Hopkins Symptom Checklist (HSCL-25)
Morbidity - disease rate
+11 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: PLNRT + PBRT + STADTExperimental Treatment4 Interventions
Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
Group II: PBRT + STADExperimental Treatment3 Interventions
Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
Group III: PBRT AloneActive Control1 Intervention
Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AA
2006
N/A
~190
LHRH agonist
2000
Completed Phase 4
~2420

Find a Location

Who is running the clinical trial?

Radiation Therapy Oncology GroupLead Sponsor
190 Previous Clinical Trials
63,135 Total Patients Enrolled
32 Trials studying Prostate Cancer
18,799 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,931,361 Total Patients Enrolled
560 Trials studying Prostate Cancer
505,381 Patients Enrolled for Prostate Cancer
Cancer and Leukemia Group BNETWORK
80 Previous Clinical Trials
116,196 Total Patients Enrolled
10 Trials studying Prostate Cancer
41,554 Patients Enrolled for Prostate Cancer

Media Library

Pelvic Lymph Node Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00567580 — Phase 3
Prostate Cancer Research Study Groups: PLNRT + PBRT + STADT, PBRT + STAD, PBRT Alone
Prostate Cancer Clinical Trial 2023: Pelvic Lymph Node Radiation Therapy Highlights & Side Effects. Trial Name: NCT00567580 — Phase 3
Pelvic Lymph Node Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00567580 — Phase 3
Prostate Cancer Patient Testimony for trial: Trial Name: NCT00567580 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study easily accessible for many people in the city?

"There are 100 enrolling patients for this study at locations including Alegant Health Cancer Center at Bergan Mercy Medical Center in Omaha, Case Comprehensive Cancer Center in Cleveland, and Alle-Kiski Medical Center in Natrona Heights."

Answered by AI

Could you please elaborate on the safety of PBRT for human subjects?

"PBRT's safety is rated highly by our team because it is a Phase 3 trial. This means that, not only is there some evidence supporting its efficacy, but there are also multiple rounds of data that support its safety."

Answered by AI

Does PBRT have a limited research history?

"As of now, 138 clinical trials are underway to explore the efficacy of PBRT. Out of those, 50 are large-scale Phase 3 trials. Although the headquarters for many of these studies are in Duarte, California, there are over 10,000 locations running PBRT trials."

Answered by AI

What skin conditions can be helped by PBRT?

"PBRT is a viable treatment option for breast cancer, radiation therapy, and endometrial thinning."

Answered by AI

Are patient volunteers still being sought for this research?

"Unfortunately, this specific study is no longer actively looking for candidates. The trial was initially posted on February 1st, 2008 and was most recently edited on June 3rd, 2022. However, there are presently 1348 studies actively enrolling patients with prostate cancer and 138 trials for PBRT actively enrolling participants."

Answered by AI

Who else is applying?

What state do they live in?
New York
Pennsylvania
New Jersey
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Capital Health Regional Cancer Center
James P. Wilmot Cancer Center at University of Rochester Medical Center
Cancer Center of Paoli Memorial Hospital
Other
How many prior treatments have patients received?
0
2

Why did patients apply to this trial?

To help find a cure for cancer and hopfully cure me of mine. Looking for new methods and or remedies in this ongoing fight I have with this disease.
PatientReceived 2+ prior treatments
Recent research and studies
The LancetJournal
The Addition of Androgen Deprivation Therapy and Pelvic Lymph Node Treatment to Prostate Bed Salvage Radiotherapy (NRG Oncology/rtog 0534 SPPORT): An International, Multicentre, Randomised Phase 3 Trial
Pollack, Alan, Theodore G Karrison, Alexander G Balogh, Leonard G Gomella, Daniel A Low, Deborah W Bruner, Jeffrey S Wefel, et al.. 2022. “The Addition of Androgen Deprivation Therapy and Pelvic Lymph Node Treatment to Prostate Bed Salvage Radiotherapy (NRG Oncology/rtog 0534 SPPORT): An International, Multicentre, Randomised Phase 3 Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(21)01790-6.
clinicaltrials.govStudy
Prostate Radiation Therapy or Short-Term Androgen Deprivation Therapy and Pelvic Lymph Node Radiation Therapy With or Without Prostate Radiation Therapy in Treating Patients With a Rising Prostate Specific Antigen (PSA) After Surgery for Prostate Cancer
2008. "Prostate Radiation Therapy or Short-Term Androgen Deprivation Therapy and Pelvic Lymph Node Radiation Therapy With or Without Prostate Radiation Therapy in Treating Patients With a Rising Prostate Specific Antigen (PSA) After Surgery for Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00567580.
All > Prostate
~104 spots leftby Apr 2025
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