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Radiotherapy for High Risk Prostate Cancer

Phase 3

Recruiting

Led By Tamim Niazi, MD

Research Sponsored by Sir Mortimer B. Davis - Jewish General Hospital

Eligibility Criteria Checklist

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

Must have

Clinical stage including at least one of the following: T3 or T4, Gleason Score > 8, and/ or Prostate-specific antigen (PSA) > 20 (ng/ml or μg/L).

ECOG performance status must be 0 or 1.

Must not have

The presence of small-cell or transitional-cell carcinoma in the biopsy specimen.

Patients with history of severe congestive heart failure will not be eligible.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the time when biopsy is done, < 6 months before randomization of participant

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is designed to compare the safety of two different radiation treatment plans for high risk prostate cancer patients.

Who is the study for?

Men with high risk prostate cancer diagnosed within the last 6 months, having a clinical stage of T3/T4, Gleason Score >8, or PSA >20. They must have no metastases on scans and can't have had previous chemotherapy for prostate cancer. Prior hormone therapy is allowed if started less than 28 days before joining. Men with severe heart failure, hip replacements, certain allergies or other serious health issues are excluded.

What is being tested?

This trial compares two radiation treatments for high risk prostate cancer: standard pelvic external beam radiation plus HDR brachytherapy boost versus hypofractionated dose escalation radiotherapy. The study aims to determine which method is safer and more effective by randomly assigning participants to one of the two treatment plans.

What are the potential side effects?

Potential side effects include urinary problems like burning or frequent urination, bowel issues such as diarrhea or discomfort, fatigue from radiation exposure, skin irritation in treated areas and erectile dysfunction due to changes in sexual function after treatment.

Eligibility Criteria

Inclusion Criteria

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

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My prostate cancer is advanced with a high Gleason score or PSA level.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

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

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My biopsy shows I have small-cell or transitional-cell cancer.

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I have never had severe congestive heart failure.

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I have had chemotherapy for prostate cancer before.

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I have had surgery for prostate cancer, but not just a TURP or castration.

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I have a serious illness that may limit my life to under 3 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the time when biopsy is done, < 6 months before randomization of participant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the time when biopsy is done, < 6 months before randomization of participant

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the time when biopsy is done, < 6 months before randomization of participant for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Freedom from biochemical failure measured by PSA level.

Predictive value of the PTEN deletion and TMPRSS2-ETS gene fusion in high risk prostate cancer patients.

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: ADT+EBRT+ HDR brachytherapy boostExperimental Treatment2 Interventions

Standard fractionation radiotherapy: 46 Gy in 23 fractions (EBRT) and a 15-Gy HDRB boost in conjunction with 28 months of androgen deprivation therapy (ADT).

Group II: ADT+Hypofractionated Dose Escalation RTActive Control2 Interventions

Hypofractionated dose escalation radiotherapy: 68 Gy in 25 fractions in conjunction with 28 months of androgen deprivation therapy (ADT).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Androgen deprivation therapy

2021

Completed Phase 4

~260

0 / 7Eligibility criteria met