Actively Recruiting
Phase I/II Trial of Pembrolizumab and Androgen-receptor Inhibitor With or Without 225Ac-J591 for Progressive Metastatic Castration Resistant Prostate Cancer
Led by Weill Medical College of Cornell University · Updated on 2026-04-21
52
Participants Needed
4
Research Sites
433 weeks
Total Duration
On this page
Sponsors
W
Weill Medical College of Cornell University
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a phase I/II study investigating the combination of 225Ac-J591 (a drug that can deliver radiation to prostate cancer cells) with pembrolizumab (immunotherapy, a drug that increases the immune system's ability to destroy cancer cells). This study will assess whether 225Ac-J591 + pembrolizumab + androgen receptor inhibitor (ARI) is more effective against prostate cancer than pembrolizumab + ARI alone.
CONDITIONS
Official Title
Phase I/II Trial of Pembrolizumab and Androgen-receptor Inhibitor With or Without 225Ac-J591 for Progressive Metastatic Castration Resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants at least 18 years old with confirmed prostate adenocarcinoma
- Agree to use contraception during treatment and for 4 months after last dose; no sperm donation during this time
- Documented progressive metastatic castration-resistant prostate cancer based on PSA progression, radiographic progression, or new bone lesions
- Must have measurable disease by RECIST 1.1, detectable circulating tumor cells, or PSA of at least 2 ng/dL
- ECOG performance status of 0 or 1
- Serum testosterone 50 ng/dL or less; must continue primary androgen deprivation if not orchiectomized
- Previous treatment with androgen receptor inhibitor or CYP 17 inhibitor in any disease state
- Normal organ and marrow function as defined by blood counts and liver/kidney tests
- Willing and able to sign informed consent
You will not qualify if you...
- Prior chemotherapy for castration-resistant prostate cancer (except docetaxel in specific settings if last dose was over 6 months ago)
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or other T-cell receptor agents
- Active autoimmune disease requiring systemic treatment in past 2 years
- Prior bone-seeking beta-emitting radioisotopes or PSMA-targeted radionuclide therapy (radium-223 allowed if last dose over 12 weeks ago)
- History of second malignancy unless cured and no evidence for 2 years
- Known myelodysplastic syndrome
- Known HIV, active Hepatitis B or C infection
- Immunodeficiency or recent immunosuppressive therapy above prednisone 10 mg daily
- Recent participation in investigational drug/device study within 4 weeks
- Recent systemic anti-cancer therapy within 4 weeks or less than 5 half-lives
- Active CNS metastases or carcinomatous meningitis unless stable and off steroids
- Recent deep vein thrombosis or pulmonary embolism within 1 month
- Any condition or therapy interfering with study participation or results
- Recent radiotherapy within 4 weeks unless recovered
- Not willing to use birth control or expecting to father children during study and 4 months after
- Recent live vaccine within 30 days
- Severe hypersensitivity to pembrolizumab
- History or current pneumonitis/interstitial lung disease requiring steroids
- Active infection needing systemic treatment
- Known active tuberculosis
- Psychiatric or substance abuse disorders interfering with study
- History of allogenic tissue or solid organ transplant
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
2
New York Presbyterian/Brooklyn Methodist Hospital
Brooklyn, New York, United States, 11215
Actively Recruiting
3
New York Presbyterian/Weill Cornell Medical Center
New York, New York, United States, 10021
Actively Recruiting
4
Columbia University Irving Cancer Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
G
GUONC Research Team
CONTACT
G
GUCLINIC Research Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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