Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
NCT ID:
NCT06129851
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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT06129851
Study Brief:
Protocol Section:
NCT06129851