Relugolix + Radiation Therapy for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen byXinglei Shen

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Kansas Medical Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This phase II trial evaluates the best duration for relugolix to be given in combination with radiation therapy when treating patients with high risk prostate cancer. Prostate cancer is a hormonal influenced cancer. Part of the usual treatment for patients with prostate cancer is androgen deprivation therapy (ADT). ADT is used to lower the amount of testosterone in the body, because testosterone appears to help prostate cancer grow. Relugolix works to reduce testosterone levels, which may inhibit proliferation of prostate cancer cells. It is approved by the Food and Drug Administration to treat prostate cancer. Adding relugolix to standard radiation therapy might work better and have fewer side effects than prior forms of hormonal therapy, but the optimal duration of relugolix in combination with radiation is not known.

Eligibility Criteria

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.

Inclusion Criteria

Hemoglobin ≥ 9 g/dL

Life expectancy > 5 years

Platelets >= 100 K/UL

+8 more

Exclusion Criteria

Simultaneously enrolled in any therapeutic clinical trial

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

I have had surgery to remove my prostate.

+6 more

Participant Groups

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.

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.

Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺 Approved in European Union as Radiation Therapy for: