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Radioactive Therapy

Vorinostat + 177Lu-PSMA-617 for Metastatic Prostate Cancer

Phase 2

Waitlist Available

Led By Michael Schweizer

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documented histologically confirmed adenocarcinoma of the prostate

Evidence of castration resistant prostate cancer as evidenced by PSA progression (per Prostate Cancer Working Group 3 [PCWG3] criteria) and a castrate serum testosterone level (i.e., ≤ 50 mg/dL)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial tests if a drug (vorinostat) can help treat metastatic prostate cancer that has spread to other parts of the body despite treatment.

Who is the study for?

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.Check my eligibility

What is being tested?

The trial is testing if combining Vorinostat (a drug that blocks enzymes needed for cell growth) with a radioactive treatment called 177Lu-PSMA-617 can effectively kill tumor cells in men whose prostate cancer has spread but shows low levels of PSMA.See study design

What are the potential side effects?

Possible side effects include fatigue, nausea, vomiting, diarrhea, blood count changes leading to increased infection risk or bleeding problems, liver function changes, kidney issues, and potential reactions at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer has been confirmed through a biopsy.

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My prostate cancer is growing despite low testosterone levels.

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I have been treated with a taxane-based chemotherapy.

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I have at least one cancer lesion that can be tracked over time with scans.

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My PSMA PET scan shows a score less than 10.

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I am able to care for myself and perform daily activities.

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I have taken hormone therapy for cancer and stopped it at least 2 weeks ago.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of patients who convert from prostate-specific membrane antigen (PSMA) low to PSMA high

Secondary outcome measures

Absolute change in PSMA standardized uptake value (SUV) mean

Incidence of adverse events

Number of discrete lesions

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (vorinostat, 177Lu-PSMA-617)Experimental Treatment10 Interventions

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 SPECT/CT and FDG PET/CT during screening and on trial. Patients undergo blood sample collection on trial and may also optionally undergo biopsy during screening and on trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography

2008

Completed Phase 2

~2240

Vorinostat

2014

Completed Phase 3

~1600

Single Photon Emission Computed Tomography

2008

Completed Phase 4

~310

Biospecimen Collection

2004

Completed Phase 2

~1700

Biopsy

2014

Completed Phase 4

~1090

Computed Tomography

2017

Completed Phase 2

~2720

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Institute for Prostate Cancer Research (IPCR)UNKNOWN

NovartisIndustry Sponsor

1,611 Previous Clinical Trials

2,721,020 Total Patients Enrolled

22 Trials studying Prostate Cancer

4,934 Patients Enrolled for Prostate Cancer

University of WashingtonLead Sponsor

1,743 Previous Clinical Trials

1,847,855 Total Patients Enrolled

18 Trials studying Prostate Cancer

8,244 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial actively enrolling participants?

"Clinicaltrials.gov shows that this medical trial, which was first posted on April 1st 2024 is not currently recruiting patients. Last updated on November 17th 2023, the study has yet to reopen its call for volunteers; however, there are 1279 other clinical trials accepting participants at present."

Answered by AI

What potential risk factors do participants need to be aware of before undergoing Treatment (vorinostat, 177Lu-PSMA-617)?

"Our team assesses the safety of this treatment (vorinostat, 177Lu-PSMA-617) to be a 2 as it is currently in Phase 2 trials. This indicates that there is some evidence for its security but no clinical data demonstrating efficacy yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Vorinostat and 177Lu-PSMA-617 for the Treatment of PSMA-Low Metastatic Castration-Resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06145633.