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Vorinostat and 177Lu-PSMA-617 for the Treatment of PSMA-Low Metastatic Castration-Resistant Prostate Cancer

StatusRecruiting
PhasePhase 2
Started2024-09-18
View on ClinicalTrials.gov ↗

Amendment history

2026-08-04
minor
Study Status v10
Re-verified, no change to tracked fields
2026-01-26
minor
Study Status v9
Primary completion date2026-07-31→2026-12-30
2026-01-21
minor
Study Status v8
Primary completion date2025-12-30→2026-07-31
2025-09-17
minor
Study Status, Arms and Interventions, Eligibility v7
InterventionsBiopsy (Procedure), Biospecimen Collection (Procedure), Bone Scan (Procedure), Computed Tomography (Procedure), Fludeoxyglucose F-18…→Biopsy Procedure (Procedure), Biospecimen Collection (Procedure), Bone Scan (Procedure), Computed Tomography (Procedure), Fludeoxyglucose…
Eligibility criteria-70 characters
[...] d off steroids at least 1 week prior to starting treatment. Patients must have received at least one taxane chemotherapy regimen. Eastern Cooperative Oncology Group (ECOG) performance status [...]
2024-12-27
minor
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Arms and Interventions v6
Lead sponsorUniversity of Washington→Fred Hutchinson Cancer Center
Study description+40 characters
[...] e gallium Ga 68 gozetotide intravenously (IV) and undergo a positron emission tomography (PET) scan on trial. Patients may go on to receive 177Lu-PSMA-617 [...] ) and bone scan on trial and during follow-up, as well as a single photon emission computed tomography (SPECT)/CT and fludeoxyglucose F-18 (FDG) PET/CT during screening and on trial and single photon emission computed tomography (SPECT)/CT on trial. Patients undergo blood sample collection on trial and may [...]
Collaborators2 to 3 entries
National Cancer Institute (NCI)
Show 5 earlier versions
2024-09-18
minor
Study Status v5
Start dateestimated 2024-09→confirmed 2024-09-18
2024-09-12
minor
Study Status v4
Start date2024-09-21→2024-09
2024-08-21
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start date2024-09-01→2024-09-21
Study sitesdetails revised at 1 of 1 site
2024-07-24
minor
Study Status v2
Start date2024-08-01→2024-09-01
2024-04-04
minor
Study Status v1
Start date2024-04-01→2024-08-01
2023-11-17
minor
Original filing
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.
Trial Details
NCT Number NCT06145633
Lead Sponsor Fred Hutchinson Cancer Center
Collaborators: Novartis, Institute for Prostate Cancer Research (IPCR), National Cancer Institute (NCI)
Conditions Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
Enrollment 15 participants
Start Date 2024-09-18
Primary Completion 2026-12-30 (estimated)
Study Completion 2027-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-06