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NCT06145633 · ClinicalTrials.gov registry record · Phase 2
Vorinostat and 177Lu-PSMA-617 for the Treatment of PSMA-Low Metastatic Castration-Resistant Prostate Cancer
A Phase 2 study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma, sponsored by Fred Hutchinson Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT06145633 is a Phase 2 study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma that is actively recruiting participants, run by Fred Hutchinson Cancer Center. The registered enrollment target is 15 participants, below the 177-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06145633, a Phase 2 study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma, is actively recruiting participants, sponsored by Fred Hutchinson Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial tests how well vorinostat works in treating patients with prostate-specific membrane antigen (PSMA)-low castration-resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) (mCRPC). Prostate cancer that has not spread to other parts of the body (localized) is typically treated through surgery or radiotherapy, which for many men is curable. Despite definitive local therapy, cancer that has come back after a period of improvement (recurrent) disease develops in 27-53% of men. Often this is detected by measurement of prostate-specific antigen (PSA) without visible evidence of metastatic disease. Lutetium Lu 177 vipivotide tetraxetan (177Lu-prostate specific membrane antigen \[PSMA\]-617) is a new small molecule PSMA-targeted radioactive therapy that has been approved by the Food and Drug Administration for the treatment of adult patients with PSMA-positive mCRPC who have been treated with androgen receptor inhibitors and taxane-based chemotherapy. Vorinostat is used to treat various types of cancer that does not get better, gets worse, or comes back during or after treatment with other drugs. Vorinostat is a drug which inhibits the enzyme histone deacetylase and may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vorinostat and 177Lu-PSMA-617 may kill more tumor cells in in patients with PSMA-low mCRPC.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy Procedure
- PROCEDURE Bone Scan
- OTHER Fludeoxyglucose F-18
Study Locations (1)
Washington
- Fred Hutch/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2024-09-18 |
| Est. Completion | 2027-12-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06145633
The ClinicalTrials.gov registry entry for NCT06145633 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 177-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (92% lower). The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Stage IVB Prostate Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06145633 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.
Frequently Asked Questions
What is clinical trial NCT06145633 about?
NCT06145633 is a clinical study titled "Vorinostat and 177Lu-PSMA-617 for the Treatment of PSMA-Low Metastatic Castration-Resistant Prostate Cancer". This phase II trial tests how well vorinostat works in treating patients with prostate-specific membrane antigen (PSMA)-low castration-resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) (mCRPC). Prostate cancer that has not s...
What is the current status of trial NCT06145633?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2024-09-18. Estimated completion is 2027-12-30.
What conditions does trial NCT06145633 study?
This clinical trial studies the following conditions: Stage IVB Prostate Cancer AJCC v8, Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma.
What interventions are being tested in trial NCT06145633?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), Bone Scan (PROCEDURE), Fludeoxyglucose F-18 (OTHER).
Who is sponsoring clinical trial NCT06145633?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06145633 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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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.