This is a single-arm, phase II study of neoadjuvant combination therapy of Androgen Deprivation Therapy (ADT), \[Gonadotropin-Releasing Hormone (GnRH) agonist Leuprolide\], androgen receptor (AR)-antagonist Darolutamide and Pembrolizumab in a stratified high-risk localized prostate cancer cohort, followed by adjuvant treatment with Pembrolizumab (12 cycles) post-radical prostatectomy (RP). Patients with National Comprehensive Cancer Network (NCCN) high-risk non-metastatic prostate cancer (localized or locally advanced) (defined as Gleason ≥8, disease stage \>=cT3a, or PSA l \>20 ng/mL) will be risk-stratified at a biopsy using Decipher, a commercial standard-of-care diagnostic assay. Patients satisfying all three criteria of high-risk genomic characteristics listed below as per the Decipher grid results will be enrolled in the study: 1. Decipher Genomic classifier, GC\>0.6 2. AR activity score/AR-output gene signature (ARoS)\>11.0 3. High Luminal B score/ PAM50 subtype signature
The objectives of this study are to evaluate if the neoadjuvant ADT, Darolutamide and Pembrolizumab treatment in high-risk prostate cancer patients stratified based on their genomic characteristics will lead to minimum residual disease (MRD). A total of 40 men ≥ 18 years of age with non-metastatic adenocarcinoma of the prostate, having NCCN high risk localized disease, risk stratified at biopsy based on Decipher score, AR activity score and Luminal B score will be enrolled.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg for 16 weeks prior to RP.
Administered at the dose of 200 mg intravenously, every 3 weeks, for a total of 5 cycles prior to RP (Neoadjuvant phase, study weeks 1, 4, 7, 10, 13 \& 16), and every 3 weeks, for a total of 12 cycles post-RP (Adjuvant phase, study weeks, 19, 22, 25, 28, 31, 34, 37, 40 43, 46, 49, \& 52). Total Pembrolizumab cycles=17
Androgen deprivation, GnRH agonist Leuprolide will be administered at a dose of 22.5 mg SQ (Eligard)/IM Lupron every 12 weeks prior to RP (Study weeks, 1 and 13).
Icahn School of Medicine at Mount Sinai
New York, New York, United States
RECRUITINGProportion of patients who achieve Minimal residual disease (MRD)
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.
Time frame: at time of surgery (At Week 17)
Complete pathological response (pCR)
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.
Time frame: After Week 17
Proportion of patients who had had their tumor downstaged
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.
Time frame: at time of surgery (At Week 17)
Adverse events assessed by NCI CTCAE (v.5.0).
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.
Time frame: Week 1 to Week 16, Week 19 to Week 52
Biochemical progression free survival bPES
bPFS is defined as the time from baseline to first evidence of biochemical progression based on PSA level or death, whichever occurs first.
Time frame: Week 22 and until 5 years after Week 17
Metastasis free survival (MFS)
Metastasis free survival (MFS) defined as time from enrollment to detection of metastasis or death, whichever occurs first.
Time frame: Week 17 and until 5 years after Week 17
Tumor Volumes
Median tumor volumes assessed by MRI at baseline and before surgery (and the corresponding change in median tumor volume from baseline to before surgery).
Time frame: Week 0 to Week 17
Immunological responses in blood
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.
Time frame: Week 0 to Week 52
Whole exome-sequencing (WES)
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.
Time frame: Week 0 to Week 17
RNA sequencing (RNA-seq)
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.
Time frame: Week 0 to Week 17
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