OncoMatch/Clinical Trials/NCT06145633
Vorinostat and 177Lu-PSMA-617 for the Treatment of PSMA-Low Metastatic Castration-Resistant Prostate Cancer
Is NCT06145633 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Lutetium Lu 177 Vipivotide Tetraxetan and Vorinostat for castration-resistant prostate carcinoma.
Treatment: Lutetium Lu 177 Vipivotide Tetraxetan · Vorinostat — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Biomarker criteria
Required: FOLH1 SUVmean < 10 by 68Ga-PSMA-11 PET (SUVmean < 10)
PSMA SUVmean < 10 as determined by 68Ga-PSMA-11 PET
Disease stage
Required: Stage IVB (AJCC v8)
Metastatic disease required
Stage IVB Prostate Cancer AJCC v8
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: androgen receptor-signaling inhibitor (abiraterone, enzalutamide, apalutamide, darolutamide)
Patients must have received a next-generation androgen receptor-signaling inhibitor (e.g. abiraterone, enzalutamide, apalutamide, darolutamide)
Cannot have received: HDAC inhibitor (valproic acid)
Any previous treatment with an HDAC inhibitor (including valproic acid)
Cannot have received: radioligand therapy (177Lu-PSMA-617)
Any previous treatment with ... 177Lu-PSMA-617
Lab requirements
Blood counts
Hemoglobin ≥ 10 g/dL; ANC ≥ 1.5 x 10^9/L; Platelet count ≥ 100 x 10^9/L
Kidney function
Calculated creatinine clearance ≥ 50 mL/min (using Cockcroft-Gault formula)
Liver function
Total bilirubin ≤ 1.5 x institutional ULN; AST and ALT ≤ 2.5 x ULN, unless liver metastases are present in which case they must be ≤ 5 x ULN; for Gilbert's Syndrome ≤ 3 x ULN
Hemoglobin ≥ 10 g/dL ... ANC ≥ 1.5 x 10^9/L ... Platelet count ≥ 100 x 10^9/L ... Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) ... AST and ALT ≤ 2.5 x ULN, unless liver metastases are present in which case they must be ≤ 5 x ULN ... for Gilbert's Syndrome ≤ 3 x ULN ... Calculated creatinine clearance ≥ 50 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Fred Hutch/University of Washington Cancer Consortium · Seattle, Washington
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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