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Monoclonal Antibodies

Radium-223 + Pembrolizumab for Prostate Cancer

Phase 2
Waitlist Available
Led By Atish Choudhury, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed adenocarcinoma of the prostate
Metastatic disease by bone scan
Timeline
Screening 3 weeks
Treatment Varies
Follow Up imaging was performed every 12 weeks and up to 25 months.
Awards & highlights

Study Summary

This trial is studying the safety and tolerability of an investigational combination of drugs, radium-223 plus pembrolizumab, for the treatment of castration-resistant prostate cancer.

Who is the study for?
Men over 18 with advanced prostate cancer that's resistant to hormone therapy can join. They must have had a biopsy confirming adenocarcinoma, show cancer progression, and have metastatic disease visible on bone scans. Participants need good organ function, an ECOG performance status of 0 or 1 (fully active or restricted in physically strenuous activity but ambulatory), and agree to use contraception.Check my eligibility
What is being tested?
The trial is testing the combination of Radium-223 (a radioactive drug) with Pembrolizumab (an immunotherapy drug) for safety and effectiveness in treating castration-resistant prostate cancer that has spread to bones.See study design
What are the potential side effects?
Possible side effects include fatigue, nausea, diarrhea, skin reactions at the injection site for pembrolizumab; radium-223 may cause nausea, diarrhea, vomiting and low blood cell counts which could lead to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer diagnosis was confirmed through a tissue examination.
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My cancer has spread to my bones, confirmed by a scan.
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I am 18 years old or older.
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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~imaging was performed every 12 weeks and up to 25 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and imaging was performed every 12 weeks and up to 25 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Increased Immune Cell Infiltration Across Arms
Secondary outcome measures
Median Overall Survival
Median Progression-Free Survival
Number of Participants With Grade 3 or Higher Treatment Related Adverse Events

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

2Treatment groups
Experimental Treatment
Group I: Radium-223Experimental Treatment1 Intervention
- Radium-223 will be administered intravenously every 4 weeks at a pre-determined dose
Group II: Pembrolizumab Plus Radium-223Experimental Treatment2 Interventions
Radium-223 will be administered intravenously every 4 weeks at a pre-determined dose Pembrolizumab will be administered intravenously every 3 weeks at a pre-determined dose Radium-223 will be halted after 3 doses. Once radiographic progressive disease occurs, the last 3 doses of radium will be given.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radium-223
2023
Completed Phase 2
~100
Pembrolizumab
2017
Completed Phase 2
~1950

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,071 Previous Clinical Trials
340,319 Total Patients Enrolled
76 Trials studying Prostate Cancer
16,070 Patients Enrolled for Prostate Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,860 Previous Clinical Trials
5,047,809 Total Patients Enrolled
26 Trials studying Prostate Cancer
16,952 Patients Enrolled for Prostate Cancer
Atish Choudhury, MDPrincipal InvestigatorDana-Farber Cancer Institute

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03093428 — Phase 2
Prostate Cancer Research Study Groups: Radium-223, Pembrolizumab Plus Radium-223
Prostate Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03093428 — Phase 2
Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03093428 — Phase 2

Frequently Asked Questions

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

What are the primary therapeutic applications of Pembrolizumab?

"Pembrolizumab is widely used for treating malignant neoplasms, as well as more specific conditions such as unresectable melanoma, microsatellite instability high and chemotherapy resistance."

Answered by AI

Is this experiment currently accepting new participants?

"According to clinicaltrials.gov, this study is no longer actively searching for patients; the trial was initially posted on June 9th 2017 and last updated on August 31st 2022. Fortunately, there are 2288 other studies that are currently recruiting volunteers."

Answered by AI

What is the aggregate number of participants in this clinical experiment?

"This trial is no longer actively seeking participants. It was initially announced on the 9th of June 2017 and last updated on 31st August 2022. For those looking for alternate studies, there are 1,315 active trials recruiting prostate cancer patients and a further 973 studies with Pembrolizumab that need volunteers."

Answered by AI

Has the FDA sanctioned Pembrolizumab for widespread use?

"The safety of Pembrolizumab was assessed with a score of 2, as it is currently in Phase 2 trials and there are data confirming its safety but none affirming efficacy."

Answered by AI

What objectives are being sought through the execution of this research?

"The primary end-point of this medical trial, which is to be documented over a two month period, evaluates the level of immune cell infiltration. Secondary objectives encompass overall survival (from randomization/registration until death from any cause), incidence of treatment associated adverse events graded as 3 or higher on NCI CTCAE version 4.0 scale and progression free survival rate determined by RECIST 1.1 criteria."

Answered by AI

What precedent has been documented regarding research on Pembrolizumab?

"Currrently, 973 active clinical trials are running for pembrolizumab with a hefty 126 of them in their concluding phase. Most experiments take place in Houston but there remains 36146 different locations looking to trial this drug."

Answered by AI
~6 spots leftby Mar 2025