Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 2

Testing Interruption of Hormonal Medications in Patients Responding Exceptionally to Therapy for Metastatic Prostate Cancer, (A-DREAM)

NCT05241860 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • OTHER Quality-of-Life Assessment
  • OTHER Questionnaire Administration
  • OTHER Follow-Up
  • OTHER Pharmacotherapy Discontinuation

Study Locations (20)

California

  • Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande
  • Mercy Cancer Center �� Carmichael — Carmichael
  • Mercy San Juan Medical Center — Carmichael
  • Epic Care-Dublin — Dublin
  • Mercy Cancer Center - Elk Grove — Elk Grove
  • Bay Area Breast Surgeons Inc — Emeryville
  • Epic Care Partners in Cancer Care — Emeryville
  • Contra Costa Regional Medical Center — Martinez
  • Mercy UC Davis Cancer Center — Merced
  • Bay Area Tumor Institute — Oakland
  • UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange
  • Eisenhower Medical Center — Rancho Mirage
  • Mercy Cancer Center - Rocklin — Rocklin
  • Mercy Cancer Center - Sacramento — Sacramento
  • Pacific Central Coast Health Center-San Luis Obispo — San Luis Obispo
  • Mission Hope Medical Oncology - Santa Maria — Santa Maria
  • Epic Care Cyberknife Center — Walnut Creek

Arkansas

  • Mercy Hospital Fort Smith — Fort Smith
  • CARTI Cancer Center — Little Rock

Arizona

  • Cancer Center at Saint Joseph's — Phoenix

Trial Details

FieldValue
Enrollment Target 79 participants
Start Date 2022-11-21
Est. Completion 2033-09-01
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05241860

The ClinicalTrials.gov registry entry for NCT05241860 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 79 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alliance for Clinical Trials in Oncology, which has 147 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 5 conditions, with Stage IVB Prostate Cancer AJCC v8 appearing as the primary indexed condition, and to 4 interventions — of which Quality-of-Life Assessment is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05241860 reports 20 study locations spanning 3 distinct geographic areas — top geographies include California, Arkansas, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05241860 about?

NCT05241860 is a clinical study titled "Testing Interruption of Hormonal Medications in Patients Responding Exceptionally to Therapy for Metastatic Prostate Cancer, (A-DREAM)". 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 p...

What is the current status of trial NCT05241860?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 79 participants. The study started on 2022-11-21. Estimated completion is 2033-09-01.

What conditions does trial NCT05241860 study?

This clinical trial studies the following conditions: Stage IVB Prostate Cancer AJCC v8, Metastatic Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Castration-Sensitive Prostate Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05241860?

The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Follow-Up (OTHER), Pharmacotherapy Discontinuation (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05241860?

This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 147 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05241860 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial