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.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• 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.

• 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.

• 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.

Locations
United States
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
Texas
MD Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Karen Hoffman, MD
khoffman1@mdanderson.org
(713) 563-2339
Time Frame
Start Date: 2024-09-10
Estimated Completion Date: 2029-06-30
Participants
Target number of participants: 120
Treatments
Experimental: Arm 1
Participants will receive 6 months of standard-of-care androgen deprivation therapy (ADT) and radiation therapy.
Experimental: Arm 2
Participants will receive 6 months of apalutamide and radiation therapy.
Experimental: Arm 3
Participants will receive 24 months of standard-of-care androgen deprivation therapy (ADT) and radiation therapy.
Experimental: Arm 4
Participants will receive 6 months of ADT, apalutamide, and radiation therapy.
Related Therapeutic Areas
Sponsors
Leads: M.D. Anderson Cancer Center
Collaborators: Janssen Scientific Affairs, LLC

This content was sourced from clinicaltrials.gov