An interventional study of Cryosurgery and Degarelix in Stage IV Prostate Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-12.
Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Not applicable, Interventional, and Treatment
This pilot phase II trial studies the side effects and how well pembrolizumab and cryosurgery work with short term androgen ablation to treat patients with prostate cancer that has traveled from the original tumor, through the body, and formed a small number of new tumors in other parts of the body (oligo-metastatic). Cryosurgery, also known as cryoablation or cryotherapy, kills tumor cells by freezing them. The process also incites an immune response within the ablated tumor. Giving monoclonal antibodies such as pembrolizumab which enhance a systemic anti-cancer immune response, may augment the effects of cryosurgery and increase tumor killing at distant (metastatic) sites.
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's enrollment of 12 is below the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is the lead sponsor of 572 studies on the registry; 73 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 67 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive standard of care degarelix SC once a month for 8 months. Within 1 month of receiving degarelix, patients receive pembrolizumab 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 pembrolizumab, patients undergo whole gland cryoablation of the prostate.
Procedure: Cryosurgery · Drug: Degarelix · Other: Laboratory Biomarker Analysis · Biological: Pembrolizumab
Undergo whole gland cryoablation
Also known as: CRYOABLATION, cryosurgical ablation
Given SC
Also known as: FE200486, Firmagon
Correlative studies
Given IV
Also known as: Keytruda, Lambrolizumab, MK-3475, SCH 900475
Number of Participants With PSA < 0.6 ng/mL
Time frame: At 1 year
Expression of PD-1
Number of participants with PD-1 expression in tumor tissue.
Time frame: Baseline
Expression of PD-L1
Number of participants with PD-L1 expression in tumor tissue.
Time frame: Baseline
| Milestone | Treatment (Pembrolizumab, Cryosurgery) |
|---|---|
| Started | 12 |
| Completed | 12 |
| Not completed | 0 |
| Participants | Treatment (Pembrolizumab, Cryosurgery) |
|---|---|
| Number of Participants With PSA < 0.6 ng/mL | 5 |
Number of participants with PD-1 expression in tumor tissue.
| Participants | Treatment (Pembrolizumab, Cryosurgery) |
|---|---|
| Expression of PD-1 | 1 |
Number of participants with PD-L1 expression in tumor tissue.
| Participants | Treatment (Pembrolizumab, Cryosurgery) |
|---|---|
| Expression of PD-L1 | 0 |
Collected over up to 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Pembrolizumab, Cryosurgery) | 0/12 (0%) | 0/12 (0%) | 12/12 (100%) |
| Event | Treatment (Pembrolizumab, Cryosurgery) |
|---|---|
| FatigueGeneral disorders | 8/12 |
| Hot flashesVascular disorders | 6/12 |
| PainMusculoskeletal and connective tissue disorders | 4/12 |
| EdemaBlood and lymphatic system disorders | 3/12 |
| Urinary urgencyRenal and urinary disorders | 3/12 |
| Urinary frequencyRenal and urinary disorders | 3/12 |
| Injection site reactionGeneral disorders | 3/12 |
| Groin PainGastrointestinal disorders | 3/12 |
| Urinary incontinenceRenal and urinary disorders | 2/12 |
| DepressionPsychiatric disorders | 2/12 |
| Age, Categorical(Participants) | Treatment (Pembrolizumab, Cryosurgery) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 6 |
| >=65 years | 6 |
| Sex: Female, Male(Participants) | Treatment (Pembrolizumab, Cryosurgery) |
|---|---|
| Female | 0 |
| Male | 12 |
| Race and Ethnicity Not Collected(Participants) | Treatment (Pembrolizumab, Cryosurgery) |
|---|
| Region of Enrollment(Participants) | Treatment (Pembrolizumab, Cryosurgery) |
|---|---|
| United States | 12 |
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins