Status:
NOT_YET_RECRUITING
Relugolix in Combination With Radiation Therapy for Treating Patients With High Risk Prostate Cancer
Lead Sponsor:
University of Kansas Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Stage IIC Prostate Cancer AJCC v8
Stage III Prostate Cancer AJCC v8
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 inf...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 23 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06129851
Start Date
November 20 2023
End Date
October 23 2026
Last Update
November 13 2023
Active Locations (1)
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1
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160