Study on Pembrolizumab and Androgen-receptor Pathway Inhibitor with or without 225Ac-J591 for Advanced Prostate Cancer

Sponsor: Weill Medical College of Cornell University

Sponsor score: 40

ClinicalTrials ID:NCT04946370

This clinical trial is testing a new treatment combination for men with advanced prostate cancer that has continued to grow despite hormone therapy. The study is exploring whether adding a drug that delivers radiation directly to cancer cells can improve treatment outcomes.

Patient Parameters

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Program Overview

This study is investigating a new treatment approach for men with advanced prostate cancer that has not responded to hormone therapy. The trial is testing a combination of drugs, including pembrolizumab (an immunotherapy that boosts the immune system to fight cancer) and an androgen receptor pathway inhibitor (ARPI), with or without a drug called 225Ac-J591. This drug delivers targeted radiation to prostate cancer cells. The study aims to find out if adding 225Ac-J591 to the treatment is more effective than using pembrolizumab and ARPI alone.

Description

This clinical trial is for men with advanced prostate cancer that has continued to grow despite hormone therapy. The study has two main parts: Phase I and Phase II.

In Phase I, researchers will determine the best dose of 225Ac-J591 to use with pembrolizumab and ARPI. Up to 12 patients will receive the treatment to find the safest and most effective dose.

In Phase II, the study will compare the effectiveness of the treatment with and without 225Ac-J591. Patients will be randomly assigned to receive either pembrolizumab and ARPI alone or with 225Ac-J591. The main goal is to see if the combination with 225Ac-J591 leads to better outcomes, such as lower PSA levels, fewer cancer cells in the blood, and changes in imaging scans.

Participants will have regular imaging scans, including CT and bone scans, every 12 weeks to monitor the cancer. They will also have a special PET/CT scan before starting treatment and at 12 weeks. Pembrolizumab will be given every 6 weeks for up to 18 cycles (about 2 years).

Eligibility Criteria

Inclusion Criteria

Men aged 18 or older with a confirmed diagnosis of prostate cancer.
Must agree to use contraception during treatment and for 4 months after the last dose.
Have advanced prostate cancer that has continued to grow despite hormone therapy.
Have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
Have low testosterone levels and continue hormone therapy if not surgically castrated.
Previously treated with certain hormone therapies like enzalutamide or abiraterone.
Have normal organ and bone marrow function based on specific blood tests.
Able to understand and sign a consent form.

Exclusion Criteria

Previous chemotherapy for advanced prostate cancer, except certain cases.
Prior treatment with specific immune therapies.
Active autoimmune disease requiring treatment in the past 2 years.
Previous treatment with certain radioactive drugs or investigational therapies.
History of another cancer unless treated and in remission for 2 years.
Known infections like HIV, Hepatitis B, or Hepatitis C.
Receiving high-dose steroids or other immune-suppressing treatments.
Participating in another clinical trial or using investigational drugs recently.
Active brain metastases or certain blood clots.
Conditions that could interfere with the study or are not in the patient's best interest.
Recent radiotherapy or planning to start certain bone-strengthening drugs during the study.
Not willing to use birth control if sexually active with partners of childbearing potential.
Planning to have children during or shortly after the study.
Recent live vaccinations.
Severe allergies to pembrolizumab or its ingredients.
History of lung disease requiring steroids.
Active infections or tuberculosis.
Psychiatric or substance abuse issues affecting study participation.
Previous organ transplants.

Locations

FACILITY	ZIP	CITY	STATE
Dana-Farber Cancer Institute	02215	Boston	Massachusetts
New York Presbyterian/Brooklyn Methodist Hospital	11215	Brooklyn	New York
New York Presbyterian/Weill Cornell Medical Center	10021	New York	New York
Columbia University Irving Cancer Center	10032	New York	New York

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