Trial · NCT07027124
Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate Cancer
NCT07027124, Phase 2, Recruiting, Icahn School of Medicine at Mount Sinai
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate Cancer. Trials, record NCT07027124. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07027124
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate Cancer
- NCT number
- NCT07027124
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 40 participants, estimated
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Conditions
- Prostate Cancer, High-risk Prostate Cancer
- Interventions
- Darolutamide, Pembrolizumab, Lupron
- First posted
- 2025-06-18
- Last updated
- 2026-10-07
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of patients who achieve Minimal residual disease (MRD) | at time of surgery (At Week 17) | MRD is defined as residual cancer burden (RCB) ≤0.25cm³ at final pathology, where RCB is calculated by multiplying the residual tumor volume with the tumor cellularity. The proportion of patients who achieve MRD will be collected at the time of surgery. |
| Secondary | Complete pathological response (pCR) | After Week 17 | Complete pathological response (pCR) is defined as the absence of viable tumor in post treatment prostatectomy specimens). pCR is typically determined by examining the radical prostatectomy specimen after surgery. |
| Secondary | Proportion of patients who had had their tumor downstaged | at time of surgery (At Week 17) | Proportion of patients who had had their tumor downstaged due to neoadjuvant Pembrolizumab, Darolutamide and ADT at the time of surgery. Downstaging will be determined using MRI and pathology separately. |
| Secondary | Adverse events assessed by NCI CTCAE (v.5.0). | Week 1 to Week 16, Week 19 to Week 52 | Adverse events assessed by NCI CTCAE (v.5.0). Incidence of AEs will be reported for the first cycle of neoadjuvant therapy, for the entire neoadjuvant treatment phase, and for the adjuvant treatment phase. |
| Secondary | Biochemical progression free survival bPES | Week 22 and until 5 years after Week 17 | bPFS is defined as the time from baseline to first evidence of biochemical progression based on PSA level or death, whichever occurs first. |
| Secondary | Metastasis free survival (MFS) | Week 17 and until 5 years after Week 17 | Metastasis free survival (MFS) defined as time from enrollment to detection of metastasis or death, whichever occurs first. |
| Secondary | Tumor Volumes | Week 0 to Week 17 | Median tumor volumes assessed by MRI at baseline and before surgery (and the corresponding change in median tumor volume from baseline to before surgery). |
| Secondary | Immunological responses in blood | Week 0 to Week 52 | A broad immunophenotyping panel will be used to define various immune subsets and their functional states, in pre-treatment and longitudinally collected whole blood samples. Longitudinally collected serum/plasma samples will be analyzed using Olink multiplex assay platform. |
| Secondary | Whole exome-sequencing (WES) | Week 0 to Week 17 | Transcriptomic and genomic changes in tissues - Whole exome-sequencing (WES) will be performed for characterization of the mutational landscape including neoantigens and differentially expressed genes and gene signatures. |
| Secondary | RNA sequencing (RNA-seq) | Week 0 to Week 17 | Transcriptomic and genomic changes in tissues - RNA sequencing (RNA-seq) will be performed for characterization of the mutational landscape including neoantigens and differentially expressed genes and gene signatures. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07027124
GET https://conductscience.org/api/trials/v1/NCT07027124/registered