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Hormone Therapy
Androgen Receptor Antagonists for Prostate Cancer
Phase < 1
Recruiting
Led By David Einstein, MD
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Testosterone >100 ng/dL within 6 months prior to enrollment with no intervening hormonal therapies
Assigned by treating physician to receive standard-of-care AR antagonist monotherapy using FDA-approved apalutamide, darolutamide, or enzalutamide
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4
Awards & highlights
Study Summary
This trial will explore if hormonal therapies can increase PSMA levels in recurrent prostate cancer patients via PET/CT scans. 15 participants will receive androgen receptor antagonist monotherapy for 4 weeks.
Who is the study for?
Men aged 40+ with prostate cancer previously treated but now showing rising PSA levels indicating recurrence. They must have a PSMA PET/CT scan suggesting recurrent cancer, normal testosterone levels, and be prescribed standard AR antagonist therapy (apalutamide, darolutamide, or enzalutamide) by their doctor.Check my eligibility
What is being tested?
This study tests if early hormonal therapies increase PSMA detected by PET/CT scans in men with recurring prostate cancer. About 15 participants will receive standard AR antagonist monotherapy and undergo PSMA level measurements for approximately 4 weeks.See study design
What are the potential side effects?
Possible side effects of the AR antagonists apalutamide, darolutamide, and enzalutamide include fatigue, high blood pressure, skin rash, falls or fractures due to bone weakness; digestive issues like nausea or diarrhea; and potential liver problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check βYesβ for the criteria belowSelect...
My testosterone level was above 100 ng/dL in the last 6 months without hormone treatments.
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My doctor has prescribed me a specific prostate cancer medication.
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My scan shows at least one area that might mean my prostate cancer has come back.
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I am over 40, had prostate cancer treatment, and my PSA levels are rising.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of Participants with New Lesions (Flare)
Secondary outcome measures
Changes in serum PSA
Changes in tumor SUV
Changes in tumor size
Trial Design
1Treatment groups
Experimental Treatment
Group I: Androgen Receptor Antagonist MonotherapyExperimental Treatment2 Interventions
Participants will receive pre-determined doses of apalutamide, darolutamide, or enzalutamide per standard care.
Participants will undergo Prostate-Specific Membrane Antigen (PSMA) PET/CT scans at weeks 1 and 4.
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteOTHER
1,078 Previous Clinical Trials
340,858 Total Patients Enrolled
Beth Israel Deaconess Medical CenterLead Sponsor
836 Previous Clinical Trials
13,010,310 Total Patients Enrolled
David Einstein, MDPrincipal InvestigatorBeth Israel Deaconess Medical Center
1 Previous Clinical Trials
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot receive AR antagonist therapy.My doctor has prescribed me a specific prostate cancer medication.My scan shows at least one area that might mean my prostate cancer has come back.My condition requires urgent treatment due to severe symptoms or high disease burden.I am over 40, had prostate cancer treatment, and my PSA levels are rising.My testosterone level was above 100 ng/dL in the last 6 months without hormone treatments.I am not taking older AR blockers like bicalutamide for my condition.
Research Study Groups:
This trial has the following groups:- Group 1: Androgen Receptor Antagonist Monotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the recruitment process for this trial still underway?
"The current status of this medical study, as reported on clinicaltrials.gov is that it has concluded its participant recruitment phase. The trial was first posted in January 1st 2023 and updated most recently on April 1st 2023 - though other trials are available for those seeking to participate at this point in time, with 2,224 currently active studies recruiting patients."
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