Finding studies
Finding studies
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Lead
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
With
PRIMARY OBJECTIVES: I. Assess feasibility via the proportion of men reaching a low prostate-specific antigen (PSA) nadir (\< 0.6 ng/ml) at 1 year. II. Evaluate the safety of cryotherapy to the prostate combined with pembrolizumab. TERTIARY OBJECTIVES: I. To evaluate the effects of combination cryotherapy / pembrolizumab on programmed cell death 1 (PD-1) and programmed cell death 1 ligand 1 (PD-L1) expression in the prostate as assessed by biopsy performed 6 months post treatment. OUTLINE: Patients receive standard of care androgen ablation with degarelix subcutaneously (SC) once a month for 8 months. Within 1 month of receiving degarelix, patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Within 3 days of receiving the first dose of pembrolizumab, patients undergo whole gland cryoablation of the prostate. After completion of study treatment, patients are followed up at 30 days and then every 12 weeks for up to 1 year.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
