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

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

• Castration-Resistant Prostate Carcinoma
• Metastatic Prostate Adenocarcinoma
• Stage IVB Prostate Cancer AJCC v8

Interventions

PROCEDURE

Biopsy Procedure

Undergo biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Scan

Undergo bone scan

PROCEDURE

Computed Tomography

Undergo CT, PET/CT, SPECT/CT

OTHER

Fludeoxyglucose F-18

Undergo FDG PET/CT

OTHER

Gallium Ga 68 Gozetotide

Given IV

DRUG

Lutetium Lu 177 Vipivotide Tetraxetan

Given 177Lu-PSMA-617

PROCEDURE

Positron Emission Tomography

Undergo 68Ga-PSMA-11 PET

PROCEDURE

Single Photon Emission Computed Tomography

Undergo SPECT/CT

DRUG

Vorinostat

Given IV

Sponsors & Collaborators

• Novartis

  collaborator INDUSTRY

• Institute for Prostate Cancer Research (IPCR)

  collaborator UNKNOWN

• National Cancer Institute (NCI)

  collaborator NIH

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

• Michael Schweizer · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-18

Primary Completion

2026-12-30

Completion

2027-12-30

FDA Drug

Yes

Countries

• United States

Study Locations