18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Increased Immune Cell Infiltration Across ArmsPrimary· 2 months
Differences in immune infiltrating cells (CD8+ T-cells and CD4+ T-cells) in bone biopsy specimens were compared from baseline to 8 weeks on study therapy between the treatment arms.
CD4+ T-cell infiltration levels
Group
Value
95% CI
Pembrolizumab Plus Radium-223
7
Radium-223
2
Pembrolizumab Plus Radium-223
14
Radium-223
3
CD8+ T-cell infiltration levels
Group
Value
95% CI
Pembrolizumab Plus Radium-223
3
Radium-223
1
Pembrolizumab Plus Radium-223
18
Radium-223
4
Number of Participants With Grade 3 or Higher Treatment Related Adverse EventsSecondary· Toxicity was assessed every cycle and up to 22.4 months.
Adverse events were assessed using NCI CTCAE (version 4.0). Treatment related adverse events were those that were deemed as "Definitely", "Probably" and "Possibly" related to the study treatment.
Group
Value
95% CI
Pembrolizumab Plus Radium-223
13
Radium-223
5
Median Progression-Free SurvivalSecondary· Imaging was performed every 12 weeks and up to 25 months.
Progression-free survival (PFS) is defined as the time from the first dose of study drug to the earlier of the first documentation of definitive disease progression by RECIST v 1.1 for soft tissue disease and PCWG2 guidelines for bone disease or death due to any cause, or censored at last imaging date.
Per RECIST, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
For the bone per PCWG2 criteria, appearance of at least 2 new lesions within 12 weeks and confirmed by a
Group
Value
95% CI
Pembrolizumab Plus Radium-223
6.1
2.7 – 10.8
Radium-223
5.7
2.6 – NA
Median Overall SurvivalSecondary· Participants were followed up for ~36 months.
Overall Survival (OS) is defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive. Median OS is estimated using Kaplan-Meier method.
Group
Value
95% CI
Pembrolizumab Plus Radium-223
16.9
12.7 – NA
Radium-223
16.0
9.0 – NA
Adverse events — posted to ClinicalTrials.gov
Time frame: AE was measured from baseline to end of treatment. Participants were on study up to 35 and 27months for combination and monotherapy arms, respectively..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Pembrolizumab Plus Radium-223
Serious: 9/31 (29%)
Deaths: 15/31
Radium-223
Serious: 3/14 (21%)
Deaths: 7/14
Serious adverse events (20 terms)
Reaction
System
Pembrolizumab Plus Radium-…
Radium-223
Adrenal insufficiency
Endocrine disorders
—
—
Back pain
Musculoskeletal and connective tissue disorders
—
—
Pneumonitis
Respiratory, thoracic and mediastinal disorders
—
—
Urinary tract infection
Infections and infestations
—
—
Abducens nerve disorder
Nervous system disorders
—
—
Acute coronary syndrome
Cardiac disorders
—
—
Anemia
Blood and lymphatic system disorders
—
—
Aspartate aminotransferase increased
Investigations
—
—
Dehydration
Metabolism and nutrition disorders
—
—
Diarrhea
Gastrointestinal disorders
—
—
Fever
General disorders
—
—
Lung infection
Infections and infestations
—
—
Oculomotor nerve disorder
Nervous system disorders
—
—
Pain
General disorders
—
—
Platelet count decreased
Investigations
—
—
Renal calculi
Renal and urinary disorders
—
—
Sepsis
Infections and infestations
—
—
Stroke
Nervous system disorders
—
—
Urinary tract obstruction
Renal and urinary disorders
—
—
White blood cell decreased
Investigations
—
—
Other adverse events (130 terms — click to expand)
This research study is studying the safety and tolerability of an investigational combination of drugs, radium-223 plus pembrolizumab as a possible treatment for castration-resistant prostate cancer.
The interventions involved in this study are:
* Radium-223
* Pembrolizumab
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05924672 — Efficacy of Ra-223 in PSMA PET Optimally Selected Patients
· Phase 2
· active not recruiting
NCT05701007 — Real World Evidence Study on Metastatic Prostate Cancer in the Pirkanmaa Hospital District in Finland
· completed
NCT05383079 — Combination of Radium-223 and Lutetium-177 PSMA-I&T in Men with Metastatic Castration-Resistant Prostate Cancer
· Phase 1, PHASE2
· active not recruiting
NCT04206319 — Radium-223 in Biochemically Recurrent Prostate Cancer
· Phase 2
· active not recruiting
NCT04109729 — Study of Nivolumab in Combination w Radium-223 in Men w Metastatic Castration Resistant Prostate Cancer
· Phase 1
· active not recruiting
Other recruiting trials for Prostate Cancer
Currently open trials in the same condition.
NCT06960798 — Characterizing the Genomic Landscape of Prostate Cancer in Native American Populations (NAT-Geno)
· recruiting
NCT07237269 — Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer
· Phase 2
· recruiting
NCT07234981 — PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Recurrent Prostate Cancer
· Phase 2
· recruiting
NCT07027124 — Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Ris
· Phase 2
· recruiting
NCT07426094 — PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate
· Phase 2, PHASE3
· recruiting
Other Dana-Farber Cancer Institute trials
Trials by the same sponsor.
NCT07519200 — Sexual Health and Rehabilitation for Women With Metastatic Breast Cancer (SHARE-MC): An Educational Intervention
· NA
· not yet recruiting
NCT07499999 — Randomized Double-Blind Phase II Trial of Baby Exemestane Versus Baby Tamoxifen in Post-Menopausal Women at High Risk fo
· Phase 2
· not yet recruiting
NCT05825469 — Development and Testing of Nutritional Algorithms (NACHO)
· NA
· not yet recruiting
NCT07516353 — my.naviGATE: A Guide to After-Treatment Effects for Adolescents and Young Adults
· NA
· not yet recruiting
NCT07513324 — Risk-adapted Therapy in HPV-positive Oropharyngeal Cancer Using Circulating Tumor (ct) HPV DNA Profiling (ReACT 2.0)
· Phase 2
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Dana-Farber Cancer Institute
Last refreshed: 28 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03093428.