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Types of Radiation Therapy for Prostate Cancer

Phase 3

Waitlist Available

Led By Mark Buyyounouski

Research Sponsored by NRG Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adenocarcinoma of the prostate treated primarily with radical prostatectomy

No clinical evidence of regional lymph node metastasis

Must not have

Severe, active co-morbidity, defined as follows: Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months, Transmural myocardial infarction within the last 6 months, Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 1 registration, Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of step 1 registration, Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic disease, Human immunodeficiency virus (HIV) positive with CD4 count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol, End-stage renal disease (ie, on dialysis or dialysis has been recommended), Prior allergic reaction to the study drugs involved in this protocol, History of inflammatory bowel disease, prior bowel surgeries (or colostomy) for any reason, or prior partial/radical cystectomy for any reason

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 3.0 years.

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial compares two types of radiation therapy given after surgery to treat prostate cancer. One type delivers higher doses of radiation over a shorter period of time, and the other uses lower doses given over a longer period of time. Researchers want to see which type works better.

Who is the study for?

Men who've had prostate surgery for adenocarcinoma, with certain pathology results (pT2 or pT3), and no evidence of metastasis. They must have a PSA level < 2.0 ng/mL post-surgery, good performance status, and be able to complete questionnaires in English or French. Excluded are those with prior long-term hormone therapy, other recent cancers except non-melanoma skin cancer, severe health issues like heart failure or uncontrolled infections.

What is being tested?

The trial is comparing two types of radiation therapy after prostate surgery: hypofractionated (higher doses over a shorter period) versus conventional (standard doses over a longer period). The goal is to see which method is more effective at killing tumor cells with fewer side effects.

What are the potential side effects?

Radiation therapy may cause fatigue, skin irritation at the treatment site, frequent urination, discomfort during urination, rectal bleeding or irritation, erectile dysfunction and bowel changes such as diarrhea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had surgery to remove my prostate cancer.

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My cancer has not spread to nearby lymph nodes.

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My cancer is classified as either pT2 or pT3.

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My surgery showed cancer cells at the edge of the tissue removed.

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My PSA level was below 2.0 ng/mL after my prostate surgery.

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My scans show no bone metastases.

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I speak English or French.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received chemotherapy before or after surgery to remove my prostate.

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I haven't had chemotherapy for another condition in the last 3 years.

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My prostate cancer was stage pT2, surgery removed it all, and my PSA is under 0.1 ng/mL.

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My lowest PSA level after prostate surgery was 0.2 or higher and my cancer is aggressive.

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I've had radiation therapy in the same area as my current cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to last follow-up. maximum follow-up at time of analysis was 3.0 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to last follow-up. maximum follow-up at time of analysis was 3.0 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 3.0 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Bowel Domain of the Expanded Prostate Cancer Index (EPIC) at Two Years

Change in Urinary Domain of the Expanded Prostate Cancer Index (EPIC) at Two Years

Secondary study objectives

Change in Bowel Domain Score of the Expanded Prostate Cancer Index (EPIC) at End of RT, 6 Months, 1 and 5 Years

Change in Urinary Domain Score of the Expanded Prostate Cancer Index (EPIC) at End of Radiation Therapy (RT), 6 Months, 1 and 5 Years

Number of Participants With Grade 3+ Adverse Events

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Hypofractionated radiation therapyExperimental Treatment2 Interventions

Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation.

Group II: Conventional radiation therapyActive Control2 Interventions

Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hypofractionated radiation therapy

2009

Completed Phase 2

~150

0 / 13Eligibility criteria met