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

NCT06129851 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-11-13

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Kansas Medical Center

    lead OTHER

Principal Investigators

  • Xinglei Shen · University of Kansas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-20
Primary Completion
2025-10-23
Completion
2026-10-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06129851 on ClinicalTrials.gov