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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
Must not have
A palpable prostatic fossa abnormality/mass suggestive of recurrence, unless shown by biopsy under ultrasound guidance not to contain cancer
Neoadjuvant chemotherapy before or after prostatectomy
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

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a lump in the prostate area that might indicate cancer has returned.
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I received chemotherapy before or after my prostate surgery.
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I have not had certain cancer treatments like cryosurgery or radiation in the pelvic area recently.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Androgen Deprivation Therapy (ADT) reduces androgen levels, which are hormones that stimulate prostate cancer cell growth, thereby slowing down or shrinking the cancer. Radiation Therapy uses high-energy x-rays to kill tumor cells directly, targeting the cancerous cells in the prostate and surrounding tissues to destroy them and prevent further growth. Understanding these mechanisms is crucial for prostate cancer patients as it helps them comprehend how these treatments control disease progression and what to expect in terms of outcomes and side effects.

Find a Location

Who is running the clinical trial?

Radiation Therapy Oncology GroupLead Sponsor
190 Previous Clinical Trials
63,134 Total Patients Enrolled
32 Trials studying Prostate Cancer
18,799 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,957,609 Total Patients Enrolled
565 Trials studying Prostate Cancer
527,213 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
~103 spots leftby Jul 2025