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OncoMatch/Clinical Trials/NCT06274047

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.

Is NCT06274047 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Apalutamide and Androgen Deprivation Therapy for androgen axis suppression.

Phase 3RecruitingM.D. Anderson Cancer CenterNCT06274047Data as of May 2026

Treatment: Apalutamide · Androgen Deprivation Therapy1. 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.

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Extracted eligibility criteria

Cancer type

Prostate Cancer

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: testosterone suppression (GnRH agonist, GnRH antagonist, anti-androgen)

Exception: 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

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.

Lab requirements

Blood counts

Platelet count ≥ 100,000/µL; Hemoglobin ≥ 9 g/dL

Kidney function

eGFR ≥ 30 mL/min using MDRD Formula

Liver function

Bilirubin ≤1.5 x ULN (Gilbert's syndrome exception: if total bilirubin >1.5 x ULN, direct bilirubin ≤ 1.5 x ULN); AST ≤ 2.5 x ULN; ALT ≤ 2.5 x ULN; Serum Albumin > 3.0 g/dL

Demonstrate adequate organ function as defined in the table below. Platelet count ≥ 100,000/µL; Hemoglobin ≥ 9 g/dL; eGFR ≥ 30 mL/min using MDRD Formula; Bilirubin ≤1.5 x ULN (Gilbert's syndrome exception: if total bilirubin >1.5 x ULN, direct bilirubin ≤ 1.5 x ULN); AST ≤ 2.5 x ULN; ALT ≤ 2.5 x ULN; Serum Albumin > 3.0 g/dL; Serum potassium ≥ 3.5 mmol/L

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of Kansas Medical Center · Kansas City, Kansas
  • Dana-Farber Cancer Institute · Boston, Massachusetts
  • MD Anderson Cancer Center · Houston, Texas

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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