Study on Vorinostat and 177Lu-PSMA-617 for Treating PSMA-Low Metastatic Castration-Resistant Prostate Cancer

Sponsor: Fred Hutchinson Cancer Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06145633

Provider View

This clinical trial is exploring how well the combination of vorinostat and 177Lu-PSMA-617 works in treating prostate cancer that has spread and is resistant to standard hormone therapy. The study aims to see if this combination can effectively target and kill cancer cells in patients with low levels of PSMA.

Patient Parameters

Program Overview

This phase II study is testing a new treatment for prostate cancer that has spread to other parts of the body and is resistant to hormone therapy. The treatment combines two drugs: vorinostat, which may stop cancer cells from growing, and 177Lu-PSMA-617, a radioactive therapy that targets cancer cells with low levels of a specific marker called PSMA. The goal is to see if this combination can kill more cancer cells in patients with this type of prostate cancer.

Description

In this study, patients will take vorinostat by mouth once a day for 28 days. They will then receive a special scan using gallium Ga 68 gozetotide to check the cancer's response. If suitable, patients may receive 177Lu-PSMA-617 through an IV as part of their standard care on the first day of each treatment cycle. This treatment cycle repeats every 6 weeks for up to 6 cycles, as long as the cancer does not progress and side effects are manageable. Patients will also undergo various scans and blood tests throughout the study and may have a biopsy.

After completing the study treatment, patients will have follow-up visits every 8 weeks for 6 months, and then every 12 weeks for up to 2 years to monitor their health and the cancer's status.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of prostate cancer.
  • Cancer must be resistant to hormone therapy and show signs of progression.
  • Low levels of PSMA as shown by a specific PET scan.
  • Must have previously received certain hormone therapies and chemotherapy.
  • Good overall health with a performance status score of 0 to 2.
  • At least one tumor that can be measured by scans.
  • Adequate blood counts and organ function based on recent tests.
  • Willing to use effective contraception during and after the study.
  • Able to follow the study protocol, including treatments and visits.

Exclusion Criteria

  • Serious medical or psychiatric conditions that could affect safety or consent.
  • Evidence of a specific aggressive type of prostate cancer.
  • Recent use of certain cancer treatments or radiation.
  • Previous treatment with similar drugs being tested in this study.
  • Ongoing severe side effects from past cancer treatments.
  • Poor medical risk due to uncontrolled health issues or infections.
  • HIV positive with low immune cell count.
  • Active hepatitis B or C infection.
  • Recent major surgery or not fully recovered from surgery.
  • Difficulty swallowing or digestive issues affecting medication absorption.
  • Recent blood clots or use of certain blood thinners.
  • Serious heart conditions, including recent heart attack or abnormal heart rhythms.

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