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NCT05683964 · ClinicalTrials.gov registry record · Early Phase 1
Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression
A Early Phase 1 study of Prostate Cancer and Prostate Adenocarcinoma, sponsored by Beth Israel Deaconess Medical Center.
- Active
- Registry status
- Early Phase 1
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT05683964: Active Early Phase 1 study of Prostate Cancer and Prostate Adenocarcinoma, sponsored by Beth Israel Deaconess Medical Center.
NCT05683964 is a Early Phase 1 study of Prostate Cancer and Prostate Adenocarcinoma that is active but no longer recruiting, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 9 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05683964, a Early Phase 1 study of Prostate Cancer and Prostate Adenocarcinoma, is active but no longer recruiting, sponsored by Beth Israel Deaconess Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this research study is to determine whether hormonal therapies used early in the course of prostate cancer could increase the amount of Prostate-Specific Membrane Antigen (PSMA) as detected by PET/CT scans for participants with recurrent prostate cancer. This study will measure PSMA levels using standard PET/CT scans and participants will receive standard-of-care androgen receptor antagonist monotherapy. The names of the treatment interventions involved in this study are: * Androgen receptor antagonist monotherapy. * PSMA PET/CT scan It is expected that about 15 people will take part in this research study. Participation in this research study is expected to last about 4 weeks.
Primary Outcome
Defined as the percentage of patients having the appearance of at least one new suspicious lesion or increase in SUV max relative to each individual's baseline.
Conditions Studied
Interventions
- DRUG Apalutamide [Erleada], darolutamide [Nubeqa], or enzalutamide [Xtandi]
- DIAGNOSTIC_TEST Prostate-Specific Membrane Antigen (PSMA) PET/CT Scan
Study Locations (1)
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2023-01-19 |
| Est. Completion | 2026-09-01 |
| Phase | Early Phase 1 |
What the registry record for NCT05683964 still lists
NCT05683964 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Apalutamide [Erleada], darolutamide [Nubeqa], or enzalutamide [Xtandi] is the first listed.
NCT05683964 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05683964 about?
NCT05683964 is a clinical study titled "Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression". The goal of this research study is to determine whether hormonal therapies used early in the course of prostate cancer could increase the amount of Prostate-Specific Membrane Antigen (PSMA) as detected by PET/CT scans for participants with recurrent prostate cancer. This study will measure PSMA leve...
What is the current status of trial NCT05683964?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 9 participants. The study started on 2023-01-19. Estimated completion is 2026-09-01.
What conditions does trial NCT05683964 study?
This clinical trial studies the following conditions: Prostate Cancer, Prostate Adenocarcinoma, Metastatic Hormone-Sensitive Prostate Cancer (mHSPC).
What interventions are being tested in trial NCT05683964?
The interventions under investigation include: Apalutamide [Erleada], darolutamide [Nubeqa], or enzalutamide [Xtandi] (DRUG), Prostate-Specific Membrane Antigen (PSMA) PET/CT Scan (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05683964?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05683964 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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