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Relugolix + Radiation Therapy for Prostate Cancer

Phase 2

Waitlist Available

Led By Xinglei Shen

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

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

Must have

Age ≥ 18 years

Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1

Must not have

Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study

Prior prostatectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will investigate the best duration of relugolix + radiation to treat high risk prostate cancer, to see if it's more effective and has fewer side effects than current hormone therapy.

Who is the study for?

This trial is for men over 18 with high risk prostate cancer who can consent to the study, have a life expectancy over 5 years, and are eligible for radiation therapy combined with ADT. They must have good organ function and agree to use contraception. It's not for those in other clinical trials, using anti-cancer drugs, with severe infections or psychiatric/social limitations, allergic reactions to study drug components, current ADT (unless testosterone levels are adequate), or prior treatments that overlap with this study.

What is being tested?

The trial is testing how long relugolix should be given alongside standard radiation therapy in treating high-risk prostate cancer. Relugolix lowers testosterone which may help slow down the growth of prostate cancer cells. The goal is to find out if adding relugolix improves outcomes and has fewer side effects than previous hormonal therapies.

What are the potential side effects?

Relugolix may cause hot flashes, fatigue, diarrhea, joint pain and changes in liver function tests. Since it lowers testosterone levels significantly, it might also lead to decreased sex drive or erectile dysfunction.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I am fully active or can carry out light work.

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My prostate cancer is classified as high or very high risk.

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I am eligible for a specific cancer treatment involving radiation and hormone therapy.

Exclusion Criteria

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

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I am not using, nor plan to use, other cancer treatments during this study.

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I have had surgery to remove my prostate.

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I haven't had a severe infection in the last 2 weeks.

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I have had previous treatments in my pelvic area that overlap with where I would receive radiation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Biochemical recurrence

Secondary study objectives

Composite quality of Life

Incidence of adverse events

Incidence of major adverse cardiovascular events

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B (relugolix, brachytherapy, external beam radiation)Experimental Treatment10 Interventions

Patients receive relugolix PO QD. Cycles repeat every 3 months for 24 months in the absence of disease progression or unacceptable toxicity. Beginning 30 to 180 days after start of relugolix, patients undergo brachytherapy and external beam radiation over 25 fractions. Patients undergo bone scan, CT or MRI or PSMA PET scan during screening. Patients also undergo DEXA scan and may optionally undergo blood sample collection throughout the trial.

Group II: Arm A (relugolix, brachytherapy, external beam radiation)Experimental Treatment10 Interventions

Patients receive relugolix PO QD. Cycles repeat every 3 months for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 30 to 180 days after start of relugolix, patients undergo brachytherapy and external beam radiation over 25 fractions. Patients undergo bone scan, CT or MRI or PSMA PET scan during screening. Patients also undergo DEXA scan and may optionally undergo blood sample collection throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dual X-ray Absorptiometry

2015

N/A

~50

Bone Scan

2015

Completed Phase 2

~50