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NCT07142551 · ClinicalTrials.gov registry record · Phase 2
Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response
A Phase 2 study of Metastatic Castration-Resistant Prostate Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT07142551: Recruiting Phase 2 study of Metastatic Castration-Resistant Prostate Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT07142551 is a Phase 2 study of Metastatic Castration-Resistant Prostate Cancer that is actively recruiting participants, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 60 participants, below the 197-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07142551, a Phase 2 study of Metastatic Castration-Resistant Prostate Cancer, is actively recruiting participants, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this study is to determine the safety and clinical effects of alternating pharmacologic (i.e. supraphysiologic) testosterone therapy with darolutamide in men with metastatic prostate cancer as first line hormonal therapy. Correlative studies will be conducted to assess the effect of alternating therapy on quality of life, gene expression and metabolic changes associated with alternating therapy.
Primary Outcome
Percent of subjects are free of clinical or radiographic progression at 24 months from initiation of treatment
Conditions Studied
Interventions
- DRUG Darolutamide
- DRUG Testosterone cypionate
- DRUG Luteinizing hormone-releasing hormone (LHRH) analogue
Study Locations (1)
Maryland
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-03-09 |
| Est. Completion | 2034-06-01 |
| Phase | Phase 2 |
What NCT07142551 shows while recruiting
NCT07142551 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 197-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Metastatic Castration-Resistant Prostate Cancer appearing as the primary indexed condition, and to 3 interventions - of which Darolutamide is the first listed.
NCT07142551 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT07142551 about?
NCT07142551 is a clinical study titled "Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response". The objective of this study is to determine the safety and clinical effects of alternating pharmacologic (i.e. supraphysiologic) testosterone therapy with darolutamide in men with metastatic prostate cancer as first line hormonal therapy. Correlative studies will be conducted to assess the effect of...
What is the current status of trial NCT07142551?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2026-03-09. Estimated completion is 2034-06-01.
What conditions does trial NCT07142551 study?
This clinical trial studies the following conditions: Metastatic Castration-Resistant Prostate Cancer.
What interventions are being tested in trial NCT07142551?
The interventions under investigation include: Darolutamide (DRUG), Testosterone cypionate (DRUG), Luteinizing hormone-releasing hormone (LHRH) analogue (DRUG).
Who is sponsoring clinical trial NCT07142551?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07142551 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic Castration-Resistant Prostate Cancer
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 NCT07142551's enrollment target sits among peer trials
60 38th of 69 higher than 30 of 69 other Metastatic Castration-Resistant Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Castration-Resistant Prostate Cancer 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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