Study on Lu-177-PSMA-617 Treatment Before Surgery for High-Risk Localized Prostate Cancer
Sponsor: Hackensack Meridian Health
ClinicalTrials ID:NCT06798558
This clinical trial is testing a new treatment using Lu-177-PSMA-617 before surgery to see if it can help manage high-risk localized prostate cancer in men. The study aims to evaluate the safety and effectiveness of this approach.
Patient Parameters
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Program Overview
The purpose of this study is to find out if giving two doses of a treatment called Lu-177-PSMA-617 before surgery can help manage high-risk localized prostate cancer. Men who have been diagnosed with this type of cancer and are eligible for surgery will receive the treatment every six weeks. After the second dose, they will undergo surgery to remove the prostate and nearby lymph nodes. The study will follow participants for safety and health outcomes for up to two years after treatment.
Description
The PRELUDE trial is a study to see how well a treatment called Lu-177-PSMA-617 works in men with high-risk localized prostate cancer. Participants will receive two doses of the treatment, six weeks apart, before having surgery to remove the prostate. The goal is to see if this treatment can help control the cancer better than surgery alone.
After receiving the treatment, participants will have surgery to remove the prostate and nearby lymph nodes. They will be monitored closely for safety and health outcomes at regular intervals, including visits at weeks 3, 6, 9, 11, and 12, as well as a follow-up visit 30 days after surgery. Long-term follow-up will continue every three months for about two years. If the cancer progresses, participants will receive standard treatments as recommended by their doctors.
Eligibility Criteria
Inclusion Criteria
- Men aged 18 or older.
- Diagnosed with prostate adenocarcinoma.
- Have high-risk prostate cancer, defined as a Gleason Score of 8 or higher from a biopsy.
- Have a positive PSMA scan showing high expression in the prostate.
- Eligible and willing to undergo surgery.
- Have a life expectancy of more than 10 years.
- Have a performance status score of 0 to 2, indicating good overall health.
- Agree to use effective contraception or remain abstinent during the study and for 14 weeks after the last treatment dose.
- Able to attend follow-up visits and comply with the treatment plan.
- Able to provide informed consent.
Exclusion Criteria
- Previous treatment for prostate cancer.
- Prior treatment with PSMA-targeted radioligand therapy or certain other radiation therapies within six months.
- Cancer that has spread beyond local lymph nodes.
- Significant bone marrow, liver, or kidney impairment.
- Other serious health conditions that make surgery risky.
- Evidence of cancer spread to distant sites.
- History of radiation or hormone therapy to the prostate.
- History of bleeding disorders or use of blood thinners.
- Active infections or other conditions that prevent surgery.
- Unable or unwilling to provide informed consent or comply with the study requirements.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | 20057 | Washington | District of Columbia |
| John Theurer Cancer Center at Hackensack University Medical Center | 07601 | Hackensack | New Jersey |
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