PROSTATE-IQ: Study on Personalized Apalutamide Treatment to Improve Quality of Life in Men with Detectable PSA After Prostate Surgery for Prostate Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06274047

Provider View

This Phase III study is exploring if personalized treatment with apalutamide can help reduce fatigue and improve quality of life for men undergoing radiation therapy after prostate surgery. The study compares this new approach to standard treatment methods.

Patient Parameters

Program Overview

The study aims to personalize prostate cancer treatment based on how aggressive the disease is. It will investigate if using apalutamide can help reduce fatigue and other side effects in men receiving radiation therapy for prostate cancer, compared to standard treatments.

Description

The study is divided into two groups based on the aggressiveness of the prostate cancer:

  • Less Aggressive Disease Group: This group will compare fatigue levels after 9 months between those receiving apalutamide alone for 6 months and those receiving standard hormone therapy.

  • More Aggressive Disease Group: This group will compare fatigue levels after 24 months between those receiving a combination of apalutamide and hormone therapy for 6 months and those receiving hormone therapy alone for 24 months.

Secondary Goals for Both Groups:

  • Compare quality of life, side effects, activity levels, sleep, cognitive function, mental health, and changes in blood sugar and cholesterol between the two treatment options.
  • Compare how long it takes for testosterone levels to return to normal and the time until further treatment is needed.
  • Compare survival rates and risk of heart problems between the two treatment options.
  • For those who agree, compare changes in body composition, such as fat and muscle mass.

Exploratory Goals for Both Groups:

  • Study the link between fatigue and inflammation in the body.
  • Investigate if genetic factors affect body composition changes with treatment.
  • Explore how genetic factors and tumor characteristics affect treatment benefits.
  • Examine the relationship between body composition changes and heart disease risk.
  • Evaluate the impact of radiation treatment on urinary and bowel function.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with prostate cancer.
  • PSA level of 0.1 or higher after prostate surgery.
  • Suitable for radiation and hormone therapy as determined by a doctor.
  • Age 18 or older.
  • Good overall health with a performance status of 2 or less.
  • Adequate organ function based on specific blood tests.
  • Ability to understand and follow study procedures.
  • Ability to understand English or Spanish.
  • Willingness to provide written consent and authorization for health information release.

Exclusion Criteria

  • Previous use of hormone therapy after prostate surgery, unless testosterone levels have recovered.
  • History of seizures or conditions that may lead to seizures.
  • Recent severe heart problems or blood clots.
  • Uncontrolled high blood pressure or digestive issues affecting absorption.
  • Active infections like HIV or hepatitis.
  • Other conditions that may interfere with the study.
  • Previous or current cancer that does not affect the study's safety or effectiveness.
  • Cancer spread beyond the pelvis or to the bones.
  • Use of medications that lower the seizure threshold, unless stopped or changed 4 weeks before starting the study treatment.

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