Personalized treatment for prostate cancer to improve quality of life after surgery

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.

This study is testing whether a personalized treatment using apalutamide can help improve the quality of life and reduce fatigue for prostate cancer patients with detectable PSA levels after surgery, compared to standard therapy.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: M.D. Anderson Cancer Center (Academic / other)
• Drugs / interventions: radiation
• Locations: 3 sites (Kansas City, Kansas and 2 other locations)
• Trial ID: NCT06274047 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to personalize treatment for prostate cancer patients who have detectable PSA levels after prostatectomy. It compares the effects of apalutamide-based therapy versus standard androgen deprivation therapy (ADT) on fatigue and quality of life in two cohorts: those with less aggressive disease and those with more aggressive disease. The study will assess various outcomes, including patient-reported quality of life, toxicity, activity levels, cognitive function, and metabolic changes over time. Participants will be monitored for 9 to 24 months depending on their risk category.

Who should consider this trial

Good fit: Ideal candidates are men over 18 with histologically confirmed prostate cancer and detectable PSA levels after radical prostatectomy who are eligible for salvage radiation and ADT.

Not a fit: Patients with non-histologically confirmed prostate cancer or those not eligible for salvage radiation and ADT may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved quality of life and reduced treatment-related fatigue for prostate cancer patients undergoing salvage radiation therapy.

How similar studies have performed: Other studies have shown promise in using personalized treatment approaches for prostate cancer, indicating potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

1. Histologically confirmed prostate cancer.
2. PSA ≥ 0.1 after radical prostatectomy.
3. Candidate for salvage radiation and ADT treatment, as determined by treating physician.
4. Age \>18 at the time of consent.
5. ECOG Performance Status ≤ 2.
6. Demonstrate adequate organ function as defined in the table below. All screening labs to be obtained within 90 days of registration.

   System Laboratory Value

   Hematological:

   Platelet count (plt) = ≥ 100,000/µL

   Hemoglobin (Hgb) = ≥ 9 g/dL

   Renal:

   eGFR = ≥ 30 mL/min using MDRD Formula

   Hepatic and Other:

   Bilirubin2 = ≤1.5 x upper limit of normal (ULN) Aspartate aminotransferase (AST) = ≤ 2.5 x ULN Alanine aminotransferase (ALT) = ≤ 2.5 x ULN Serum Albumin = \> 3.0 g/dL Serum potassium = ≥ 3.5 mmol/L 2In subjects with Gilbert's syndrome, if total bilirubin is \>1.5 x ULN, measure direct and indirect bilirubin; if direct bilirubin is ≤ 1.5 x ULN, subject may be eligible.
7. Ability to understand and comply with study procedures for the entire length of the study as determined by the site investigator or protocol designee.
8. 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.
9. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. Participants must have the ability to understand and willingness to sign the written informed consent document.

Exclusion Criteria:

1. 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.
2. History of any of the following:

   * Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year prior to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign CNS or meningeal disease which may require treatment with surgery or radiation therapy).
   * Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization. Any condition that in the opinion of the investigator, would preclude participation in this study.
3. Current evidence of any of the following:

   * Uncontrolled hypertension (consistently \>160 systolic or \>100 diastolic)
   * Gastrointestinal disorder affecting absorption
   * Active infection (eg, human immunodeficiency virus \[HIV\] or viral hepatitis).
   * Any condition that in the opinion of the investigator, would preclude participation in this study.
4. 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.
5. Confirmed extrapelvic or bone disease
6. 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.

Where this trial is running

Kansas City, Kansas and 2 other locations

• University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
• MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Karen Hoffman, MD — M.D. Anderson Cancer Center
• Study coordinator: Karen Hoffman, MD

Conditions Androgen Axis Suppression; Prostatectomy; Prostate Cancer; Prostate; Salvage Radiation; ADT; Quality of Life