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Not yet recruitingPhase 2

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 months, 24 months, 36 months
  • Procedures mentioned: MRI scans, CT scans, Blood draws, X-rays, PET scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Cycles repeat every 3 months for 12 months in the absence of disease progression or unacceptable toxicity."
  • "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."
  • "Cycles repeat every 3 months for 24 months in the absence of disease progression or unacceptable toxicity."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria: * Ability of participant or Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent * Age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1 * Life expectancy \> 5 years * Patient diagnosed with National Comprehensive Cancer Network (NCCN) high risk and very high risk prostate cancer. * High risk is defined as: * T3a or * Grade group 4 or 5 or * Prostate-specific antigen (PSA) \> 20 ng/mL * Very high risk is defined as: * T3b to T4 or * Primary Gleason pattern 5 or * Two or three high-risk features or * \> 4 cores with grade group 4 or 5 * Eligible for treatment with combination brachytherapy, external beam radiation, and ADT * Leukocytes \>= 1.0 K/UL * Platelets \>= 100 K/UL * Hemoglobin ≥ 9 g/dL * Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x upper limit of normal (ULN) * Men with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contraception listed for the duration of study participation and for 2 weeks following completion of relugolix therapy Exclusion Criteria: * Simultaneously enrolled in any therapeutic clinical trial * Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study * Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements * Has a known allergic reaction to any excipient or component contained in the study drug formulation * Active grade 3 (per the National Cancer Institute \[NCI\] CTCAE, version 5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment * Current androgen deprivation therapy (unless testosterone \> 50 ng/dL). Please note prior or concurrent bicalutamide at 50 mg/daily or less is allowed. Prior androgen deprivation therapy is allowed if testosterone has recovered to \> 50 ng/dL * Prolonged echocardiogram corrected QT (QTc) interval \> 440 ns * Prior pelvic therapy that would significantly overlap with radiation treatment fields * Prior prostatectomy

Study sites (1)

KS