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Hormone Therapy
Hormone Therapy Break for Metastatic Prostate Cancer (A-DREAM Trial)
Phase 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
A-DREAM Trial 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.Check my eligibility
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.See study design
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.
A-DREAM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My scans showed cancer spread before starting hormone therapy.
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My prostate cancer has spread to other parts of my body.
Select...
I am currently on strong hormone therapy for advanced prostate cancer.
Select...
My cancer has not spread to my liver or brain.
A-DREAM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Treatment-free with eugonadal testosterone (> 150 ng/dl)
Secondary outcome measures
Cancer-specific survival
Duration off-treatment
Non-cancer specific survival
+5 moreA-DREAM 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.
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Who is running the clinical trial?
Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,559 Total Patients Enrolled
30 Trials studying Prostate Cancer
5,924 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,648 Previous Clinical Trials
40,931,985 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,171 Patients Enrolled for Prostate Cancer
Atish D. Choudhury, MD, PhDStudy ChairDana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have an active second cancer, except for certain skin or superficial bladder cancers.My PSA level is 5 ng/ml or higher before starting intense hormone therapy.My scans showed cancer spread before starting hormone therapy.I am on hormone therapy for cancer using specific medications.I have not undergone surgical castration.My prostate cancer has spread to other parts of my body.I am currently on strong hormone therapy for advanced prostate cancer.I can take care of myself and am up and about more than 50% of my waking hours.I have had local treatment for prostate cancer and up to 6 cycles of docetaxel. Radiation for metastatic sites was also done.I have been on continuous testosterone suppression for my cancer for 18 to 24 months.My cancer has not spread to my liver or brain.I have not used experimental treatments for my prostate cancer.I have been treated with ARPI for at least 360 days, with short breaks allowed.I've had hormone therapy for cancer, but my cancer progressed after stopping it when my testosterone was normal or high.I haven't used ARPI before my current intense hormone therapy for prostate cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (discontinue hormonal medication, follow up)
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.
Are there any vacancies for this experiment in progress?
"Affirmative, the clinicaltrial.gov listing confirms that recruitment is presently underway for this medical study which was first posted on November 21st 2020 and last updated on December 14th 2022. In total, 75 patients are needed across a single centre."
Answered by AI
Is the protocol of ceasing hormonal medication and continued monitoring officially endorsed by the FDA?
"Treatment (discontinue hormonal medication, follow up) was assigned a score of 2. This is because although there have been some studies that prove this intervention to be safe, no clinical trial data exists to suggest its efficacy."
Answered by AI
What is the highest patient enrollment for this investigation?
"Affirmative. According to clinicaltrials.gov, this medical trial that began on November 21st 2022 is still actively seeking participants. 75 individuals are needed for the research and it will be conducted in 1 site."
Answered by AI
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