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New treatment option for Androgen Axis Suppression
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.
ClinicalTrials.gov ID: NCT06274047
What this study is testing
What is Apalutamide?
Apalutamide is an investigational medicine, being studied as a potential treatment for androgen axis suppression.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 1. Personalize treatment for prostate cancer based on how aggressive the disease is and 2.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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.
You likely can't join if
- Use of post-prostatectomy testosterone suppression prior to registration (use of GnRH agonist or antagonist, with or without an anti-androgen)...
- Use of testosterone suppression prior to prostatectomy if the ArteraAI Prostate Test (Post-RP) is required to risk stratify patients (those patients...
- Confirmed extrapelvic or bone disease based on conventional imaging
- 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...
- Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary...
See the full eligibility criteria
- 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...
- 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...
- 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...
- Use of testosterone suppression prior to prostatectomy if the ArteraAI Prostate Test (Post-RP) is required to risk stratify patients (those patients with PSA ≤0.5 and no evidence of nodal involvement require ArteraAI...
- Confirmed extrapelvic or bone disease based on conventional imaging
- 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...
- Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks)...
- 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.
- Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible...
The study team makes the final eligibility decision.
Where it's taking place
- Gilbert, Arizona, United States
- Chicago, Illinois, United States
- Kansas City, Kansas, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gilbert, Arizona, United States; Chicago, Illinois, United States; Kansas City, Kansas, United States; Boston, Massachusetts, United States; New York, New York, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.