NCT06129851

Relugolix in Combination With Radiation Therapy for Treating Patients With High Risk Prostate Cancer

Quantifying Optimal Relugolix Duration With Radiation in High Risk Prostate Cancer (QURE-PC)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. To compare the biochemical recurrence rate between 12 and 24 months of relugolix in patients with high risk prostate cancer treated with combination external beam radiation and brachytherapy. SECONDARY OBJECTIVES: I. To compare the composite quality of life in patient treated with 12 months and 24 months of relugolix as assessed by the Expanded Prostate Composite Index Short Form (EPIC-26) instrument. II. To compare the treatment related toxicity between 12 months and 24 months of relugolix as assessed by Common Terminology Criteria for Adverse Events version 5.0. (CTCAE v 5.0) criteria. III. To compare the rate of major adverse cardiovascular events (MACE) in patients treated with 12 and 24 months of relugolix. IV. To establish the rate of patient compliance using patient reported drug diary. V. To compare the rate of testosterone recovery after 12 and 24 months of relugolix. EXPLORATORY OBJECTIVE: I. To establish Decipher genomic classifier as predictor of cancer control. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive relugolix orally (PO) once daily (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, computed tomography (CT) or magnetic resonance imaging (MRI) or prostate-specific membrane antigen (PSMA) positron emission tomography (PET) scan during screening. Patients also undergo dual x-ray absorptiometry (DEXA) scan and may optionally undergo blood sample collection throughout the trial. ARM B: 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. After completion of study treatment, patients in Arm A are followed up every 3 months for 12 months and then every 6 months for up to 36 months and patients in Arm B are followed up every 6 months for up 36 months.

Conditions

• Stage IIC Prostate Cancer AJCC v8
• Stage III Prostate Cancer AJCC v8
• Stage IV Prostate Cancer AJCC v8

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Bone Scan	Undergo bone scan
RADIATION	Brachytherapy	Undergo brachytherapy
PROCEDURE	Computed Tomography	Undergo CT
PROCEDURE	Dual X-ray Absorptiometry	Undergo DEXA scan
RADIATION	External Beam Radiation Therapy	Undergo external beam radiation therapy
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
PROCEDURE	PSMA PET Scan	Undergo PSMA PET
OTHER	Questionnaire Administration	Ancillary studies
DRUG	Relugolix	Given PO

Timeline

• Start date: 2023-11-20
• Primary completion: 2025-10-23
• Completion: 2026-10-23
• First posted: 2023-11-13
• Last updated: 2023-11-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study