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

Launched by UNIVERSITY OF KANSAS MEDICAL CENTER · Nov 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called relugolix combined with radiation therapy to treat men with high-risk prostate cancer. Prostate cancer can grow more quickly when there are high levels of testosterone, so relugolix helps lower those levels. The goal of this study is to find out how long relugolix should be given alongside radiation treatment to help improve outcomes for patients while potentially causing fewer side effects than older hormone therapies.

To participate in this trial, men aged 18 and older who have been diagnosed with high-risk or very high-risk prostate cancer may be eligible. This includes those with specific cancer characteristics, such as advanced tumor stages or high prostate-specific antigen (PSA) levels. Participants will need to provide informed consent and meet other health criteria. Throughout the trial, they can expect regular check-ups and monitoring, as well as safety measures to ensure their health during treatment. It's important to note that this trial is not yet recruiting participants, so those interested will need to wait until it begins.

Gender

MALE

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