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GnRH Antagonist

SBRT + Relugolix for Prostate Cancer

Phase 2

Recruiting

Led By James Yu

Research Sponsored by Yale University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Current use of medications that cause QT prolongation

Connective tissue disease such as lupus, scleroderma, or dermatomyositis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years post treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if a new drug combined with radiation therapy is more effective than radiation therapy alone for treating prostate cancer. #prostatecancer #radiationtherapy #drugs

Who is the study for?

Men aged 18+ with specific types of prostate cancer (cFIR/cgUIR) can join. They must have a Gleason score of 3+4 with PSA <20 ng/mL or Gleason 6 and PSA between >10 and <20 ng/mL. Excluded are those on recent investigational drugs, with heart issues like long QT syndrome, history of surgical castration, prior prostate cancer treatments, certain medication use, allergies to relugolix, inflammatory bowel diseases, connective tissue diseases or if GNRH/SBRT therapy is not suitable.

What is being tested?

This trial tests the effectiveness and safety of SBRT alone versus SBRT combined with an oral drug called Relugolix in treating cFIR/cgUIR prostate cancer. It aims to see if combining these treatments improves PSA levels better than SBRT alone and assesses their impact on sexual and hormonal function at six months.

What are the potential side effects?

Possible side effects include allergic reactions to Relugolix; heart issues such as prolonged QT interval which could lead to arrhythmias; potential aggravation of ulcerative colitis or other inflammatory bowel diseases; exacerbation of connective tissue disorders like lupus.

Eligibility Criteria

Inclusion Criteria

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

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Exclusion Criteria

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

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I am taking medication that affects my heart's rhythm.

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I have a connective tissue disease like lupus, scleroderma, or dermatomyositis.

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I have been diagnosed with congenital long QT syndrome.

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I have undergone surgical castration.

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I have had surgery or radiation aimed at my prostate for cancer.

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I cannot undergo GNRH antagonist therapy or SBRT to the prostate due to medical reasons.

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I have a history of ulcerative colitis or another inflammatory bowel disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years post treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Proportion of participants that attain PSA nadir

Secondary study objectives

Change in Quality of life assessment using the EPIC-26 survey

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Active Control

Group I: Relugolix and SBRTActive Control2 Interventions

SBRT and Relugolix SBRT along with 30 days of total relugolix (study drug) will be used. Relugolix starting 14 days to 17 days prior to the first treatment.

Group II: Stereotactic body radiotherapyActive Control1 Intervention

SBRT Though a range of doses are delivered nationally for IR prostate cancer, the most common regimen is 7.25 Gy- 8.00 Gy x 5 fractions, given over 2 weeks.

0 / 8Eligibility criteria met