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Alpha Therapy

Pembrolizumab + AR Inhibitors for Prostate Cancer

Q: Does this experiment have an age restriction?

This trial is for patients aged 18 to 99. However, if the patient falls outside of that age range, there are 109 studies for those under 18 and 2354 trials for seniors aged 65 and up.

Q: How many people are allowed to take part in this experiment?

That is accurate. The clinicaltrials.gov website has the most recent information regarding this study, which was first posted on 8/12/2021 and last updated 9/27/2022. There are 4 active recruitment sites for the 76 open participant spots.

Q: Can new participants join this research project?

The information available on clinicaltrials.gov indicates that this study is still recruiting patients as of September 27th, 2022. This trial was originally posted on August 12th, 2021 and has been updated several times since then. They are looking for a total of 76 participants that will be spread out between 4 different sites.

Q: Could I potentially qualify to participate in this research study?

Those that wish to take part in this <a href="https://www.withpower.com/clinical-trials/prostate-cancer">prostate cancer</a> clinical trial must be aged between 18 and 99. There are only 76 spots available in total.

Q: What diseases or conditions is 225Ac-J591 commonly used as a therapy for?

225Ac-J591 is a standard treatment for malignant neoplasms, but can also be used to ameliorate other conditions like microsatellite instability high and disease progression after chemotherapy.

Q: Do we have precedent for using 225Ac-J591 in this way?

City of Hope was the first institution to study 225Ac-J591 back in 2010 and there have been 251 completed trials since then. There are over a thousand studies currently recruiting, with a significant portion being based in Brooklyn, MA.

Q: What is the intended outcome of this research?

The purpose of this study, which will take place over the course of 100 months, is to assess the proportion of patients that experience dose-limiting toxicity following treatment with pembrolizumab and 225Ac-J591. Additionally, researchers will track changes in 1-year progression-free survival rate (defined as imaging or biochemical evidence), changes in biochemical progression-free survival rate (PSA level increase), and changes in overall survival rate.

Phase 1 & 2

Recruiting

Led By Scott Tagawa, MD, MS

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

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

Must have

Have serum testosterone < 50 ng/dL. Subjects must continue primary androgen deprivation with an LHRH/GnRH analogue (agonist/antagonist) if they have not undergone orchiectomy

Patients must have normal organ and marrow function as defined: Absolute neutrophil count >2,000 cells/mm3, Hemoglobin ≥9 g/dL, Platelet count >150,000 x 109/mcL, Serum creatinine <1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 50 mL/min/1.73 m2 by Cockcroft-Gault, Serum total bilirubin <1.5 x ULN (unless due to Gilbert's syndrome in which case direct bilirubin must be normal), Serum AST and ALT <3 x ULN in absence of liver metastases; < 5x ULN if due to liver metastases (in both circumstances bilirubin must meet entry criteria), Serum internalized normalized ratio (INR) OR prothrombin time (PT) AND activated partial thromboplastin time (aPTT) must be <1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants

Timeline

Screening 3 weeks

Treatment Varies

Follow Up will be collected at the time of visit 1 through 1 year on study

Awards & highlights

Study Summary

This trial is testing a new prostate cancer treatment that combines two drugs: one that delivers radiation to cancer cells, and one that strengthens the immune system's ability to destroy cancer cells.

Who is the study for?

Men over 18 with advanced prostate cancer that's resistant to hormone therapy and has progressed after certain treatments. They must have a good performance status, normal organ function, and agree to contraception during the trial plus 4 months after. Exclusions include other cancers within 2 years, active infections like HIV or hepatitis, recent blood clots or radiotherapy, autoimmune diseases requiring treatment in the last 2 years, current participation in another study drug trial.Check my eligibility

What is being tested?

The trial is testing if adding a radioactive drug called 225Ac-J591 to pembrolizumab (an immunotherapy) and an ARPI (androgen receptor pathway inhibitor) can better fight prostate cancer than just pembrolizumab + ARPI. It's a phase I/II study which means they're looking at safety and effectiveness.See study design

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as fatigue, skin issues, inflammation of organs; radiation-related effects from the radioactive drug; hormonal changes due to ARPIs; plus general risks associated with cancer therapies.

Eligibility Criteria

Inclusion Criteria

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

Select...

My testosterone levels are below 50 ng/dL, and I am on hormone therapy or have had an orchiectomy.

Select...

My blood counts and kidney, liver, and clotting functions are within normal ranges.

Select...

My prostate cancer is worsening, shown by rising PSA levels, new bone lesions, or growth in scans.

Select...

I am older than 18 years.

Select...

I am fully active or can carry out light work.

Select...

I am a man over 18 with a confirmed prostate cancer diagnosis.

Select...

I agree to use contraception and not donate sperm for 4 months after my last treatment dose.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ will be collected at the time of visit 1 through 1 year on study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~will be collected at the time of visit 1 through 1 year on study

This trial's timeline: 3 weeks for screening, Varies for treatment, and will be collected at the time of visit 1 through 1 year on study for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in composite response rate of pembrolizumab and ARPI with or without 225Ac-J591

Determination of optimal dose of 225Ac-J591 for phase II

Proportion of patients with dose-limiting toxicity (DLT) following treatment with pembrolizumab and 225Ac-J591

Secondary outcome measures

Change in biochemical progression-free survival

Change in overall survival following treatment

Change in proportion with 1-year progression-free survival

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Pembrolizumab + ARPIExperimental Treatment3 Interventions

Patients will receive pembrolizumab (400mg every 6 weeks) and ARPI (standard dose schedule) without 225Ac-J591.

Group II: Pembrolizumab + 225Ac-J591 + ARPIExperimental Treatment4 Interventions

Patients will receive one dose of 225Ac-J591 (single dose, either 65 or 90 Kbq/kg) in combination with pembrolizumab (400mg every 6 weeks) and ARPI (standard dose schedule, examples of ARPI include enzalutamide and apalutamide).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

225Ac-J591

2017

Completed Phase 1

~40

Pembrolizumab

FDA approved

68Ga-PSMA-11

2019

Completed Phase 3

~170

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor

3,896 Previous Clinical Trials

5,062,283 Total Patients Enrolled

26 Trials studying Prostate Cancer

16,921 Patients Enrolled for Prostate Cancer

Weill Medical College of Cornell UniversityLead Sponsor

1,058 Previous Clinical Trials

1,316,694 Total Patients Enrolled

48 Trials studying Prostate Cancer

35,563 Patients Enrolled for Prostate Cancer

United States Department of DefenseFED

865 Previous Clinical Trials

327,623 Total Patients Enrolled

38 Trials studying Prostate Cancer

9,128 Patients Enrolled for Prostate Cancer

Media Library

225Ac-J591 (Alpha Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04946370 — Phase 1 & 2

Prostate Cancer Research Study Groups: Pembrolizumab + 225Ac-J591 + ARPI, Pembrolizumab + ARPI

Prostate Cancer Clinical Trial 2023: 225Ac-J591 Highlights & Side Effects. Trial Name: NCT04946370 — Phase 1 & 2

Frequently Asked Questions

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

Does this experiment have an age restriction?

"This trial is for patients aged 18 to 99. However, if the patient falls outside of that age range, there are 109 studies for those under 18 and 2354 trials for seniors aged 65 and up."

Answered by AI

How many people are allowed to take part in this experiment?

"That is accurate. The clinicaltrials.gov website has the most recent information regarding this study, which was first posted on 8/12/2021 and last updated 9/27/2022. There are 4 active recruitment sites for the 76 open participant spots."

Answered by AI

Can new participants join this research project?

"The information available on clinicaltrials.gov indicates that this study is still recruiting patients as of September 27th, 2022. This trial was originally posted on August 12th, 2021 and has been updated several times since then. They are looking for a total of 76 participants that will be spread out between 4 different sites."

Answered by AI

Could I potentially qualify to participate in this research study?

"Those that wish to take part in this prostate cancer clinical trial must be aged between 18 and 99. There are only 76 spots available in total."

Answered by AI

What diseases or conditions is 225Ac-J591 commonly used as a therapy for?

"225Ac-J591 is a standard treatment for malignant neoplasms, but can also be used to ameliorate other conditions like microsatellite instability high and disease progression after chemotherapy."

Answered by AI

Do we have precedent for using 225Ac-J591 in this way?

"City of Hope was the first institution to study 225Ac-J591 back in 2010 and there have been 251 completed trials since then. There are over a thousand studies currently recruiting, with a significant portion being based in Brooklyn, MA."

Answered by AI

What is the intended outcome of this research?

"The purpose of this study, which will take place over the course of 100 months, is to assess the proportion of patients that experience dose-limiting toxicity following treatment with pembrolizumab and 225Ac-J591. Additionally, researchers will track changes in 1-year progression-free survival rate (defined as imaging or biochemical evidence), changes in biochemical progression-free survival rate (PSA level increase), and changes in overall survival rate."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase I/II Trial of Pembrolizumab and Androgen-receptor Pathway Inhibitor With or Without 225Ac-J591 for Progressive Metastatic Castration Resistant Prostate Cancer

2021. "Phase I/II Trial of Pembrolizumab and Androgen-receptor Pathway Inhibitor With or Without 225Ac-J591 for Progressive Metastatic Castration Resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04946370.

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