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Hormone Therapy

Hormone Therapy Break for Metastatic Prostate Cancer (A-DREAM Trial)

Phase 2
Waitlist Available
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have had evidence of metastatic disease by bone scan, or nodal or visceral lesions on computed tomography (CT) or magnetic resonance imaging (MRI) prior to starting on intense antiandrogen therapy (ADT)
Histologic or clinical diagnosis of metastatic prostate cancer
Must not have
Prostate specific antigen (PSA) >= 5 ng/ml prior to initiating intense ADT
No history of surgical castration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
No Placebo-Only Group

Summary

This triallooks at taking breaks from antiandrogen therapy in metastatic prostate cancer patients responding well to treatment. Doctors may be able to use this data to safely allow testosterone recovery.

Who is the study for?
This trial is for men with metastatic hormone-sensitive prostate cancer who have responded well to intense antiandrogen therapy. They must not have liver or brain metastases, should be on continuous testosterone suppression for 18-24 months, and treated with ARPIs like abiraterone or enzalutamide for at least a year. Men can't join if they're very sick (ECOG 0-2), have high PSA levels, are hypogonadal before treatment, or had surgical castration.
What is being tested?
The A-DREAM trial is testing whether patients with advanced prostate cancer can safely take breaks from their hormonal medications after responding exceptionally well to them. It involves stopping the usual drugs that lower testosterone and block male hormones in cancer cells under doctor supervision to see if this allows natural testosterone recovery without worsening the disease.
What are the potential side effects?
Since the intervention involves discontinuing medication rather than administering new treatments, side effects may include changes related to increasing testosterone levels such as mood swings, increased libido, and potential growth of prostate cancer if it's not adequately controlled.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My scans showed cancer spread before starting hormone therapy.
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My prostate cancer has spread to other parts of my body.
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I am currently on strong hormone therapy for advanced prostate cancer.
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My cancer has not spread to my liver or brain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My PSA level is 5 ng/ml or higher before starting intense hormone therapy.
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I have not undergone surgical castration.
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I can take care of myself and am up and about more than 50% of my waking hours.
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I have not used experimental treatments for my prostate cancer.
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I haven't used ARPI before my current intense hormone therapy for prostate cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Treatment-free with eugonadal testosterone (> 150 ng/dl)
Secondary study objectives
Cancer-specific survival
Duration off-treatment
Non-cancer specific survival
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (discontinue hormonal medication, follow up)Experimental Treatment4 Interventions
Patients stop both hormonal medications (medication to decrease testosterone levels in the body and potent oral hormonal medication to block growth signals from male hormones in the cancer cells). Patients are then followed every 12 months for symptoms. Patients with an increase in PSA level to greater than or equal to 5 ng/ml, changes on imaging studies suggesting that their cancer is growing back, or symptoms that the doctor thinks is related to their cancer growing back, resume both hormonal treatments.

Find a Location

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor
518 Previous Clinical Trials
222,318 Total Patients Enrolled
29 Trials studying Prostate Cancer
5,836 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,926 Previous Clinical Trials
41,017,938 Total Patients Enrolled
516 Trials studying Prostate Cancer
332,960 Patients Enrolled for Prostate Cancer
Atish D. Choudhury, MD, PhDStudy ChairDana-Farber Cancer Institute

Media Library

Antiandrogen Therapy (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05241860 — Phase 2
Prostate Cancer Research Study Groups: Treatment (discontinue hormonal medication, follow up)
Prostate Cancer Clinical Trial 2023: Antiandrogen Therapy Highlights & Side Effects. Trial Name: NCT05241860 — Phase 2
Antiandrogen Therapy (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05241860 — Phase 2
~25 spots leftby Nov 2025