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NCT06212583 · ClinicalTrials.gov registry record · Phase 2
High-Risk Metachronous Oligometastatic Prostate Cancer Trial
A Phase 2 study of Prostate Cancer and Oligometastatic Disease, sponsored by University of Maryland, Baltimore.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 88
- Enrollment target
- 1
- Study location
NCT06212583: Recruiting Phase 2 study of Prostate Cancer and Oligometastatic Disease, sponsored by University of Maryland, Baltimore.
NCT06212583 is a Phase 2 study of Prostate Cancer and Oligometastatic Disease that is actively recruiting participants, run by University of Maryland, Baltimore. The registered enrollment target is 88 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06212583, a Phase 2 study of Prostate Cancer and Oligometastatic Disease, is actively recruiting participants, sponsored by University of Maryland, Baltimore.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 88 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research study is to compare the effects, good and/or bad, of using the standard of care treatment, hormonal therapy + Stereotactic Ablative Radiation (SABR) to the metastatic lesions, compared to standard of care and addition of 6-months of niraparib/abiraterone acetate combination pills and prednisone for participants with recurrent metastatic prostate cancer.
Primary Outcome
PSA evaluation of progression at 18-month PSA , defined as PSA \> 0.2 ng/mL in patients initially treated with radical prostatectomy and greater than nadir + 2 ng/mL for patients initially treated with definitive radiation, with testosterone \>100 ng/dl of men who have oligometastatic castration-sensitive prostate cancer with high-risk mutations (TP53, BRCA1/2, PALB2, ATM, BRIP1, CHEK2, FANCA, RAD51B, RAD54L, MUTYH) treated with ADT + SABR MDT (6-mos) versus ADT + SABR MDT + niraparib/abirateron
Conditions Studied
Interventions
- RADIATION Stereotactic ablative radiation therapy (SABR)
- DRUG Androgen deprivation therapy (ADT)
- DRUG niraparib/abiraterone acetate
Study Locations (1)
Maryland
- University of Maryland Greenebaum Cancer Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2024-04-17 |
| Est. Completion | 2029-12-31 |
| Phase | Phase 2 |
What NCT06212583 shows while recruiting
NCT06212583 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (86% lower).
The record links to 2 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 3 interventions - of which Stereotactic ablative radiation therapy (SABR) is the first listed.
NCT06212583 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06212583 about?
NCT06212583 is a clinical study titled "High-Risk Metachronous Oligometastatic Prostate Cancer Trial". The purpose of this research study is to compare the effects, good and/or bad, of using the standard of care treatment, hormonal therapy + Stereotactic Ablative Radiation (SABR) to the metastatic lesions, compared to standard of care and addition of 6-months of niraparib/abiraterone acetate combinat...
What is the current status of trial NCT06212583?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 88 participants. The study started on 2024-04-17. Estimated completion is 2029-12-31.
What conditions does trial NCT06212583 study?
This clinical trial studies the following conditions: Prostate Cancer, Oligometastatic Disease.
What interventions are being tested in trial NCT06212583?
The interventions under investigation include: Stereotactic ablative radiation therapy (SABR) (RADIATION), Androgen deprivation therapy (ADT) (DRUG), niraparib/abiraterone acetate (DRUG).
Who is sponsoring clinical trial NCT06212583?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06212583 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
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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 NCT06212583's enrollment target sits among peer trials
88 361st of 735 higher than 374 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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.
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