PROSTATE-IQ: Parallel RandOmized STudy of Personalized Apalutamide Treatment and Evaluation to Im… (NCT06274047) | Clinical Trial Compass
RecruitingPhase 3
PROSTATE-IQ: Parallel RandOmized STudy of Personalized Apalutamide Treatment and Evaluation to Improve Quality of Life in Post-Operative Radiation With Androgen Axis Suppression. A Phase III Multi-center Study for Men With Detectable PSA After Prostatectomy for Prostate Cancer.
United States120 participantsStarted 2024-09-10
Plain-language summary
1. Personalize treatment for prostate cancer based on how aggressive the disease is and
2. Learn if apalutamide-based treatment can help to reduce fatigue and other side effects of treatment in participants who are being treated with radiation therapy for prostate cancer, as compared to standard therapy.
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. Histologically confirmed prostate cancer.
✓. PSA ≥ 0.1 after radical prostatectomy.
✓. Candidate for salvage radiation and ADT treatment, as determined by treating physician.
✓. Age \>18 at the time of consent.
✓. ECOG Performance Status ≤ 2.
✓. Demonstrate adequate organ function as defined in the table below. All screening labs to be obtained within 90 days of registration.
✓. Ability to understand and comply with study procedures for the entire length of the study as determined by the site investigator or protocol designee.
✓. Ability to understand English or Spanish language as determined by the site investigator or protocol designee. Since the primary outcome is a questionnaire available in English and Spanish.
Exclusion criteria
✕. Use of post-prostatectomy testosterone suppression prior to registration (use of GnRH agonist or antagonist, with or without an anti-androgen). However, participants with testosterone recovery after post-prostatectomy testosterone suppression are eligible (testosterone recovery defined as total testosterone \> 190 ng/dL) regardless of how long their testosterone was suppressed.
✕. History of any of the following:
✕. Current evidence of any of the following:
What they're measuring
1
Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue)
Timeframe: Through study completion; an average of 1 year.
. Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
✕. Confirmed extrapelvic or bone disease
✕. Medications known to lower the seizure threshold (listed in section 5 below) must be discontinued or substituted 4 weeks prior to C1D1 of study treatment for participants on arms receiving apalutamide.