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

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
University of Kansas Medical Center
Study ID
NCT06129851
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 20, 2023
Status verified
Nov 2023
Primary completion
Oct 23, 2025
Completion
Oct 23, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (relugolix, brachytherapy, external beam radiation)
    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.
  • Experimental: Arm B (relugolix, brachytherapy, external beam radiation)
    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.

Primary Outcome Measure

Biochemical recurrence [ Time Frame: Up to 3 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Kansas Cancer CenterKansas CityKansas66160
Xinglei Shen
[email protected]
913-588-3600
Xinglei Shen (PRINCIPAL_INVESTIGATOR)

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By research site
University of Kansas Cancer Center· Kansas City, KS

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