Study on PSMA-High: Comparing Radiation and Hormone Therapy with and without 177Lu-PSMA-617 for High-Risk Prostate Cancer

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60

ClinicalTrials ID:NCT07550517

Provider View

This clinical trial is exploring whether adding the study drug 177Lu-PSMA-617 to standard radiation and a shorter hormone therapy can be safe and effective for men with high-risk localized prostate cancer, and if it can reduce side effects compared to longer hormone therapy.

Patient Parameters

Program Overview

The purpose of this study is to find out if adding the study drug 177Lu-PSMA-617 to standard radiation therapy and a shorter course of hormone therapy (6 months) is safe and effective for men with high-risk localized prostate cancer. The study also aims to see if this combination can reduce the side effects associated with longer hormone therapy (24 months).

Description

Men with high-risk localized prostate cancer often face challenging treatment options. This study is looking at a new approach that combines a study drug, 177Lu-PSMA-617, with standard radiation therapy and a shorter hormone therapy. The goal is to see if this combination can effectively treat the cancer while reducing the side effects that come with long-term hormone therapy, such as fatigue, mood changes, and other health issues. The study will compare this new approach to the current standard treatment, which involves longer hormone therapy. Researchers hope to find a treatment that is both effective and easier on patients.

Eligibility Criteria

Inclusion Criteria

  • Must have high-risk prostate cancer with one of the following: stage cT3a, Grade Group 4 or 5, or PSA > 20 ng/mL.
  • Confirmed diagnosis of prostate adenocarcinoma.
  • Cancer must be localized, with no spread to lymph nodes or other areas as shown by standard imaging tests.
  • Must have a specific PSMA-PET scan result with a prostate tumor SUVmax > 10.
  • Eligible for standard prostate cancer treatment, including radiation and hormone therapy.
  • Must be 18 years or older.
  • Expected to live at least 24 more months.
  • Must be in good general health with an ECOG performance status of 0 to 2.
  • Must have adequate blood cell counts and organ function based on recent tests.
  • Men with partners who can become pregnant must agree to use condoms during and for 6 months after treatment.
  • Must be able to understand and sign a consent form to participate.

Exclusion Criteria

  • Have very high-risk prostate cancer with more advanced features.
  • Have had any previous treatment for prostate cancer, except for up to 45 days of hormone therapy.
  • Have had any previous radiation to the pelvis.
  • Have cancer that has spread to lymph nodes or other areas as shown by imaging tests.
  • Have castration-resistant prostate cancer.
  • Are receiving other investigational treatments.
  • Are part of another treatment study involving radiation, surgery, or cancer drugs.
  • Have inadequate blood cell counts or organ function.
  • Cannot lie flat or tolerate imaging or radiation procedures.
  • Have a serious medical condition that could affect participation.
  • Have a condition that prevents receiving pelvic radiation.
  • Do not agree to sign the consent form.

Locations

FACILITYZIPCITYSTATE
Johns Hopkins University21287BaltimoreMaryland

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