A Phase 2 interventional study of Biopsy Procedure and Biospecimen Collection in Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma and Stage IVB Prostate Cancer AJCC v8, sponsored by Fred Hutchinson Cancer Center. Recruiting at 1 site in United States. Open to male participants. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Fred Hutchinson Cancer Center · Phase 2, Interventional, and Treatment
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.
OUTLINE:
Patients receive vorinostat orally (PO) once a day (QD) for 28 days and then receive 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 IV per standard of care (SOC) on day 1 of each cycle. Treatment repeats every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) and bone scan on trial and during follow-up, as well as a 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 also optionally undergo biopsy during screening and on trial.
After completion of study treatment, patients are followed up every 8 weeks for 6 months and then every 12 weeks for up to 2 years.
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This study's planned enrollment of 15 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
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Exclusion Criteria:
Patients receive vorinostat PO QD for 28 days and then receive gallium Ga 68 gozetotide IV and undergo a PET scan on trial. Patients may go on to receive 177Lu-PSMA-617 IV per SOC on day 1 of each cycle. Treatment repeats every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT and bone scan on trial and during follow-up, as well as a FDG PET/CT during screening and on trial and SPECT/CT on trial. Patients undergo blood sample collection on trial and may also optionally undergo biopsy during screening and on trial.
Procedure: Biopsy Procedure · Procedure: Biospecimen Collection · Procedure: Bone Scan · Procedure: Computed Tomography · Other: Fludeoxyglucose F-18 · Other: Gallium Ga 68 Gozetotide · Drug: Lutetium Lu 177 Vipivotide Tetraxetan · Procedure: Positron Emission Tomography · Procedure: Single Photon Emission Computed Tomography · Drug: Vorinostat
Undergo biopsy
Also known as: Biopsy, BIOPSY_TYPE, Bx
Undergo blood sample collection
Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo bone scan
Also known as: Bone Scintigraphy
Undergo CT, PET/CT, SPECT/CT
Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography
Undergo FDG PET/CT
Also known as: 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18
Given IV
Also known as: (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC, (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68Ga)Glu-urea-Lys(Ahx)-HBED-CC, 68Ga-DKFZ-PSMA-11, 68Ga-HBED-CC-PSMA, 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, 68Ga-PSMA, 68Ga-PSMA-11, 68Ga-PSMA-HBED-CC, [68Ga] Prostate-specific Membrane Antigen 11, [68Ga]GaPSMA-11, AAA 517, AAA-517, AAA517, Ga PSMA, Ga-68 labeled DKFZ-PSMA-11, Ga-68 labeled PSMA-11, GA-68 PSMA-11, Gallium Ga 68 PSMA-11, Gallium Ga 68-labeled PSMA-11, GALLIUM GA-68 GOZETOTIDE, Gallium-68 PSMA, Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, GaPSMA, PSMA-HBED-CC GA-68
Given 177Lu-PSMA-617
Also known as: 177Lu-labeled PSMA-617, 177Lu-PSMA-617, AAA 617, AAA-617, AAA617, Lu177-PSMA-617, Lutetium Lu 177-PSMA-617, LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN, Lutetium-177-PSMA-617, Pluvicto
Undergo 68Ga-PSMA-11 PET
Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT
Undergo SPECT/CT
Also known as: Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, Single-Photon Emission Computed, single-photon emission computed tomography, SPECT, SPECT imaging, SPECT SCAN, SPET, ST, tomography, emission computed, single photon, Tomography, Emission-Computed, Single-Photon
Given IV
Also known as: L-001079038, MSK-390, SAHA, Suberanilohydroxamic Acid, Suberoylanilide Hydroxamic Acid, Zolinza
Proportion of patients who convert from prostate-specific membrane antigen (PSMA) low to PSMA high
Will be calculated as the percentage with 95% confidence interval (CI) of the total number of patients who had PSMA-high expression on re-assessment gallium Ga 68 gozetotide (68Ga)-PSMA-11 positron emission tomography (PET).
Time frame: Up to 40 weeks
Objective radiographic response rate
Will be determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.
Time frame: Up to 2 years
Prostate specific antigen (PSA)50 response rate
The percent decline in PSA compared to baseline (the PSA level prior to initiation of lutetium Lu 177 vipivotide tetraxetan will be calculated for each patient for every on-study PSA value obtained. PSA50 response will be defined as a decline in PSA ≥ 50% compared to baseline. Will be reported as a percentage with 95% CI.
Time frame: Baseline up to 2 years
Progression free survival (PFS)
Disease progression measured by modified RECIST criteria or Prostate Cancer Working Group 3 criteria for bone lesions and clinical progression as determined by the treating physician. Will be estimated using Kaplan-Meier method.
Time frame: From the start of treatment until disease progression, clinical progression, or death, whichever occurs first, assessed up to 2 years
PSA PFS
For patients showing an initial decline in PSA from baseline, PSA progression will be defined as an increase in PSA ≥ 25% and ≥ 2 ng/mL above the nadir, and which is confirmed by a second value 3 or more weeks later. For those with no decline in PSA from baseline, PSA progression will be defined as an increase in PSA that is ≥ 25% and ≥ 2ng/mL after 12 weeks. Will be estimated using Kaplan-Meier method.
Time frame: From the start of treatment until PSA progression, assessed up to 2 years
Overall survival
Will be estimated using Kaplan-Meier method.
Time frame: From the start of treatment until death from any cause, assessed up to 2 years
Number of discrete lesions
Will determine the number of discrete lesions on imaging converted from low to high PSMA expression across the study population at the time of re-assessment 68Ga-PSMA-11 PET.
Time frame: Up to 40 weeks
Absolute change in PSMA standardized uptake value (SUV) mean
PSMA SUVmean will be determined by an experienced nuclear medicine physician by measuring the PSMA SUV at each site of PSMA positive disease and dividing by the total PSMA positive tumor volume.
Time frame: Up to 40 weeks
Incidence of adverse events
Will be assessed per National Cancer Institute Common Terminology Criteria for Adverse Event version 5.0 guidelines.
Time frame: Up to 2 years
Plan to share: No
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