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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: Active Phase 2 study of Stage IVB Prostate Cancer AJCC v8 and Metastatic Prostate Carcinoma, sponsored by Alliance for Clinical Trials in Oncology.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The proportion of men who experience 18-month treatment-free interval from therapy with eugonadal testosterone (to \>= 150 ng/ml) after treatment interruption will be calculated for the study cohort.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2022-11-21 |
| Est. Completion | 2033-09-01 |
| Phase | Phase 2 |
What the registry record for NCT05241860 still lists
NCT05241860 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 176-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (55% lower).
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 names 20 study sites across 3 states, led by 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.
Learn More About Clinical Trials
Similar trials for Stage IVB Prostate Cancer AJCC v8
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05241860's enrollment target sits among peer trials
79 18th of 45 higher than 28 of 45 other Stage IVB Prostate Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IVB Prostate Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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