Hormone Therapy Break for Metastatic Prostate Cancer

(A-DREAM Trial)

Recruiting at 339 trial locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Alliance for Clinical Trials in Oncology

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase II trial examines antiandrogen therapy interruptions in patients with hormone-sensitive prostate cancer that has spread to other places in the body (metastatic) responding exceptionally well to androgen receptor-pathway inhibitor therapy. The usual treatment for patients with metastatic prostate cancer is to receive hormonal medications including a medication to decrease testosterone levels in the body and a potent oral hormonal medication to block growth signals from male hormones (like testosterone) in the cancer cells. Patients whose cancer is responding exceptionally well to this therapy may take a break from these medications according to their doctor's guidance. This trial may help doctors determine if stopping treatment can allow for testosterone recovery.

Research Team

Atish D. Choudhury, MD, PhD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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.

Inclusion Criteria

My scans showed cancer spread before starting hormone therapy.

I am on hormone therapy for cancer using specific medications.

Radiographic evidence of disease is not required at the time of enrollment

Exclusion 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.

Testosterone < 50 ng/dl at time of enrollment to A032101

Treatment Details

Interventions

• Antiandrogen Therapy (Hormone Therapy)

Trial Overview 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.

Participant Groups

Group I: Treatment (discontinue hormonal medication, follow up) Experimental Treatment 4 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.

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials

521

Recruited

224,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+