Actively Recruiting
Vorinostat and 177Lu-PSMA-617 for the Treatment of PSMA-Low Metastatic Castration-Resistant Prostate Cancer
Led by Fred Hutchinson Cancer Center · Updated on 2026-01-28
15
Participants Needed
1
Research Sites
171 weeks
Total Duration
On this page
Sponsors
F
Fred Hutchinson Cancer Center
Lead Sponsor
N
Novartis
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Vorinostat and 177Lu-PSMA-617 for the Treatment of PSMA-Low Metastatic Castration-Resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed adenocarcinoma of the prostate
- Evidence of castration-resistant prostate cancer with PSA progression and castrate serum testosterone 30 50 mg/dL
- PSMA SUVmean less than 10 as shown by 68Ga-PSMA-11 PET scan
- Previous treatment with next-generation androgen receptor-signaling inhibitors with at least 2-week washout
- ECOG performance status between 0 and 2
- At least one lesion measurable or assessable by CT or bone scan
- Hemoglobin 2 10 g/dL within 28 days before treatment
- Absolute neutrophil count 2 1.5 x 10^9/L within 28 days before treatment
- Platelet count 2 100 x 10^9/L within 28 days before treatment
- Total bilirubin 4 1.5 x institutional upper limit of normal within 28 days before treatment
- AST and ALT 4 2.5 x upper limit of normal (or 5 x ULN if liver metastases present) within 28 days before treatment
- Creatinine clearance 2 50 mL/min within 28 days before treatment
- Use of two forms of contraception during and for 3 months after treatment if sexually active and of childbearing potential
- Willingness and ability to comply with study protocol and visits
You will not qualify if you...
- Serious or unstable medical or psychiatric conditions interfering with safety or consent
- Evidence of metastatic neuroendocrine or small cell prostate cancer
- Systemic therapy or radiotherapy within 2 weeks before study treatment (except LHRH analogues)
- Previous treatment with HDAC inhibitors or 177Lu-PSMA-617
- Persistent toxicities greater than grade 2 from prior cancer therapy (except alopecia or stable neuropathy)
- Poor medical risk due to uncontrolled disorders or infections
- HIV positive with CD4 count less than 200
- Active hepatitis B or C infection
- Major surgery within 2 weeks before starting study treatment
- Inability to swallow oral medication or gastrointestinal disorders affecting absorption
- Deep vein thrombosis or pulmonary embolism within past 6 months
- Current use of coumarin-derived anticoagulants like warfarin
- Serious cardiac disorders including uncontrolled arrhythmia, recent heart attack, prolonged QT interval, or congenital long QT syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
M
Michael Schweizer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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