Testing Interruption of Hormonal Medications in Patients Responding Exceptionally to Therapy for Metastatic Prostate Cancer, (A-DREAM)
A Phase 2 Trial of ADT Interruption in Patients Responding Exceptionally to AR-Pathway Inhibitor in Metastatic Hormone-Sensitive Prostate Cancer (MHSPC): A-DREAM
Sponsor: Alliance for Clinical Trials in Oncology + National Cancer Institute (NCI)
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Treatment-free with eugonadal testosterone (> 150 ng/dl)
Time frame: At 18 months
Secondary Endpoints
Time to eugonadal testosterone
Duration off-treatment
Radiographic progression-free survival
Eligibility Criteria
Inclusion Criteria: * Histologic or clinical diagnosis of metastatic prostate cancer * 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) * Radiographic evidence of disease is not required at the time of enrollment * No metastases to liver or to brain, as these represent aggressive variant disease biology for which intermittent treatment may not be favored * Must currently be receiving intense ADT for metastatic hormone sensitive prostate cancer (mHSPC) * Testosterone suppression (TS) with luteinizing hormone releasing hormone (LHRH)-agonist or LHRH-antagonist AND * An approved secondary androgen receptor pathway inhibitor (ARPI) abiraterone, enzalutamide, or apalutamide (or darolutamide if approved for this indication) * Must have remained on testosterone suppression for metastatic disease continuously (without treatmen…
Read full criteria on CT.gov →✦ Analyst Commentary
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