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NCT05241860 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Stage IVB Prostate Cancer AJCC v8 and Metastatic Prostate Carcinoma, sponsored by Alliance for Clinical Trials in Oncology.

Active
Registry status
Phase 2
Development phase
79
Enrollment target
20
Study locations

NCT05241860 is a Phase 2 study of Stage IVB Prostate Cancer AJCC v8 and Metastatic Prostate Carcinoma that is active but no longer recruiting, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 79 participants, below the 176-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (55% lower). The trial reports 20 study locations across 3 states.

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The verdict

NCT05241860, a Phase 2 study of Stage IVB Prostate Cancer AJCC v8 and Metastatic Prostate Carcinoma, is active but no longer recruiting, sponsored by Alliance for Clinical Trials in Oncology.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
79 participants
Enrollment target
20
Study locations

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

What the Registry Record Tells You About NCT05241860

The ClinicalTrials.gov registry entry for NCT05241860 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 79 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 176-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (55% lower). The listed sponsor is Alliance for Clinical Trials in Oncology, which has 446 total studies on file at ClinicalTrials.gov.

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.

NCT05241860 reports 20 study locations spanning 3 distinct geographic areas - top geographies include California, Arkansas, Arizona.

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.

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).

Who is sponsoring clinical trial NCT05241860?

This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.