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A-DREAM — ADT + ARPI interruption in exceptional responders, metastatic hormone-sensitive prostate cancer (mHSPC)

Abstract: 5004 · Session: Oral Abstract Session (Genitourinary Cancer — Prostate), Sat May 30, 2026 · Presenter: Atish D. Choudhury, MD, PhD (Dana-Farber Cancer Institute / Harvard Medical School) · Embargo: at presentation

At a glance

  • Sponsor: Alliance for Clinical Trials in Oncology (NCI National Clinical Trials Network); Alliance A032101
  • PI / presenter: Atish D. Choudhury, MD, PhD (Dana-Farber Cancer Institute / Harvard Medical School)
  • NCT ID: NCT05241860
  • Phase: 2
  • Design: Single-arm, open-label, multicenter (NCTN). Patients with mHSPC on ADT + ARPI who achieved exceptional response (serum PSA <0.2 ng/mL, stable/decreasing) after 18–24 months of ADT and ≥12 months of an ARPI interrupted both ADT and ARPI; treatment resumed per protocol on PSA/radiographic progression.
  • N: 79 enrolled (78 eligible/evaluable) of planned 75; activated July 2022, enrollment completed March 2024
  • Primary endpoint(s): 18-month treatment-free survival (proportion remaining treatment-free at 18 months)
  • Comparator: None (single-arm feasibility trial)
  • Indication: Metastatic hormone-sensitive prostate cancer (mHSPC), exceptional responders to ADT + ARPI
  • Line: Treatment interruption after first-line intensified hormonal therapy

Headline result

Among 78 evaluable exceptional responders who interrupted ADT + ARPI, 45 (57.7%) remained treatment-free at 18 months — meeting the trial's feasibility bar — and 32 of those (41.0%) also recovered eugonadal testosterone while off treatment. Overall, 52 patients (66.7%) experienced testosterone recovery regardless of treatment-free status by 18 months. At a median follow-up of 26.9 months, 38.5% remained off treatment (P=.0249) with a median duration off treatment of 24.5 months; 37.2% resumed ADT/ARPI per protocol. Higher-volume disease predicted earlier need to resume therapy (HR 3.05; 95% CI, 1.60–5.81), while prior radiation to metastatic sites was associated with longer treatment-free time (HR 0.42; 95% CI, 0.18–0.94). Survival data remain immature: 24-month rPFS 80.7% (95% CI, 71.5%–91.1%) and OS 95.0% (95% CI, 91.7%–100.0%). The results support feasibility of treatment suspension in deeply responding mHSPC patients.

Mechanism / class

ADT (androgen deprivation therapy) suppresses gonadal testosterone; ARPIs (androgen receptor pathway inhibitors — e.g., abiraterone, apalutamide, enzalutamide, darolutamide) block AR signaling or androgen synthesis. Intensified ADT + ARPI is standard first-line therapy for mHSPC. A-DREAM tests de-escalation/interruption rather than a new agent, aiming to restore testosterone and quality of life in patients with deep, durable responses.

Practice-changing?

Pending. A-DREAM is a single-arm feasibility study, not a randomized non-inferiority trial, and survival data are immature. It does not by itself license routine treatment interruption, but it provides the first prospective NCTN evidence that suspension is feasible in carefully selected exceptional responders and identifies predictors (disease volume, metastasis-directed radiation) to guide patient selection and future randomized de-escalation designs.

Sources

  • ASCO Meeting Library / abstract: https://www.asco.org/abstracts-presentations/ABSTRACT440678
  • CancerNetwork: https://www.cancernetwork.com/view/adt-arpi-suspension-displays-feasibility-in-responders-with-metastatic-hspc
  • OncoDaily (ASCO 2026 prostate trials): https://oncodaily.com/oncolibrary/prostate-cancer-trials-at-asco-2026
  • Medscape (ASCO 2026 prostate overview): https://www.medscape.com/viewarticle/mdangle-asco-2026-prostate-cancer-overview-2026a1000cd4
  • ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT05241860