Vorinostat + 177Lu-PSMA-617 for Metastatic Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether combining vorinostat and 177Lu-PSMA-617 can effectively target metastatic prostate cancer that resists standard hormone treatments (castration-resistant). Vorinostat stops cancer cell growth, while 177Lu-PSMA-617 (also known as Lutetium Lu 177 vipivotide tetraxetan or Pluvicto) is a radioactive therapy targeting prostate cancer cells. The goal is to determine if this combination can more effectively kill cancer cells in patients whose cancer does not show strong markers (PSMA-low) typically used for targeting. Men with a confirmed diagnosis of prostate cancer that is resistant to standard hormone therapy and has spread beyond the prostate are potential candidates for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial requires a 2-week period without taking androgen receptor-signaling inhibitors and at least 1 week without steroids before starting treatment. If you are on these medications, you will need to stop them for the specified time before participating.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that vorinostat has been tested in patients with advanced prostate cancer and is generally well-tolerated. Some patients experienced side effects like tiredness, diarrhea, and nausea, but these are usually manageable.
The FDA has approved Lutetium Lu 177 Vipivotide Tetraxetan for treating a specific type of prostate cancer, indicating it has passed safety tests for that purpose. Studies indicate that this treatment is generally well-tolerated, with dry mouth and nausea as the most common side effects. These side effects are often mild and manageable with standard care.
Overall, both treatments have been studied and are considered safe within their respective trials. However, discussing personal health with a healthcare provider before joining any trial is important.12345Why are researchers excited about this trial's treatments?
Researchers are excited about using Vorinostat + 177Lu-PSMA-617 for metastatic prostate cancer because this combination offers a unique approach to treatment. Unlike traditional therapies like hormone therapy and chemotherapy, 177Lu-PSMA-617 targets prostate-specific membrane antigen (PSMA) on cancer cells, delivering radiation directly to the tumor while sparing healthy tissue. Vorinostat, a histone deacetylase inhibitor, may enhance the effectiveness of this targeted radiation by making cancer cells more susceptible to treatment. This innovative strategy not only aims to improve precision in attacking cancer cells but also hopes to reduce side effects often associated with conventional treatments.
What evidence suggests that vorinostat and 177Lu-PSMA-617 might be effective for metastatic prostate cancer?
This trial will evaluate the combination of vorinostat and 177Lu-PSMA-617 for metastatic prostate cancer. Research has shown that vorinostat, a drug that inhibits enzymes necessary for cancer cell growth, holds promise for treating advanced prostate cancer that no longer responds to hormone therapy. In earlier studies, vorinostat slowed the disease in some patients for at least six months. Meanwhile, 177Lu-PSMA-617, a targeted radioactive treatment, has been approved for this type of prostate cancer and has shown positive results. Studies found it extended patients' lives and reduced cancer markers in many cases. This trial will test whether combining these treatments enhances their effectiveness for patients with a specific type of prostate cancer called PSMA-low mCRPC.14678
Who Is on the Research Team?
Michael Schweizer
Principal Investigator
Fred Hutch/University of Washington Cancer Consortium
Are You a Good Fit for This Trial?
Men with advanced prostate cancer that is resistant to hormone therapy and has low levels of a protein called PSMA may join this trial. They should have tried at least one chemotherapy and be in fairly good health, with their major organs functioning well. Men must agree to use two effective birth control methods during the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive vorinostat orally once a day for 28 days, followed by gallium Ga 68 gozetotide IV and a PET scan. Treatment with 177Lu-PSMA-617 IV may occur on day 1 of each cycle, repeating every 6 weeks for up to 6 cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up every 8 weeks for 6 months and then every 12 weeks for up to 2 years.
What Are the Treatments Tested in This Trial?
Interventions
- Lutetium Lu 177 Vipivotide Tetraxetan
- Vorinostat
Lutetium Lu 177 Vipivotide Tetraxetan is already approved in United States, European Union for the following indications:
- Metastatic castration-resistant prostate cancer (mCRPC) in adults who have been treated with androgen receptor inhibitors and taxane-based chemotherapy
- Treatment of adult patients with progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibitors and taxane-based chemotherapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor
Fred Hutchinson Cancer Center
Lead Sponsor
Novartis
Industry Sponsor
Vasant Narasimhan
Novartis
Chief Executive Officer since 2018
MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government
Shreeram Aradhye
Novartis
Chief Medical Officer since 2022
MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania
Institute for Prostate Cancer Research (IPCR)
Collaborator
National Cancer Institute (NCI)
Collaborator