RECRUITING

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.

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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.

Quick Facts

Study Start:2024-09-10

Study Completion:2029-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06274047

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. 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.	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.

Inclusion Criteria

Exclusion 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.
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.

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.

Contacts and Locations

Study Contact

Karen Hoffman, MD

CONTACT

(713) 563-2339

khoffman1@mdanderson.org

Principal Investigator

Karen Hoffman, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Karen Hoffman, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-10

Study Completion Date2029-06-30

Study Record Updates

Study Start Date2024-09-10

Study Completion Date2029-06-30

Terms related to this study

Keywords Provided by Researchers

Prostate
Salvage Radiation
ADT
Quality of Life

Additional Relevant MeSH Terms

Androgen Axis Suppression
Prostatectomy
Prostate Cancer