Trial Outcomes & Findings for Pembrolizumab and Cryosurgery in Treating Patients With Newly Diagnosed, Oligo-metastatic Prostate Cancer (NCT NCT02489357)

NCT ID: NCT02489357

Last Updated: 2021-11-12

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

12 participants

Primary outcome timeframe

At 1 year

Results posted on

2021-11-12

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Pembrolizumab, Cryosurgery) 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. Cryosurgery: Undergo whole gland cryoablation Degarelix: Given SC Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Pembrolizumab, Cryosurgery) n=12 Participants 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. Cryosurgery: Undergo whole gland cryoablation Degarelix: Given SC Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV
Age, Categorical <=18 years	0 Participants n=12 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=12 Participants
Age, Categorical >=65 years	6 Participants n=12 Participants
Sex: Female, Male Female	0 Participants n=12 Participants
Sex: Female, Male Male	12 Participants n=12 Participants
Region of Enrollment United States	12 Participants n=12 Participants

PRIMARY outcome

Timeframe: At 1 year

Population: Data was not collected in 1/12 participants due to lost to follow up before one year.

Outcome measures

Outcome measures
Measure	Treatment (Pembrolizumab, Cryosurgery) n=11 Participants 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. Cryosurgery: Undergo whole gland cryoablation Degarelix: Given SC Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV
Number of Participants With PSA < 0.6 ng/mL	5 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: 1 participant refused biopsy. Only 2/11 samples were evaluable for this outcome measure.

Number of participants with PD-1 expression in tumor tissue.

Outcome measures

Outcome measures
Measure	Treatment (Pembrolizumab, Cryosurgery) n=2 Participants 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. Cryosurgery: Undergo whole gland cryoablation Degarelix: Given SC Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV
Expression of PD-1	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: 1 participant refused biopsy. Only 2/11 samples were evaluable for this outcome measure.

Number of participants with PD-L1 expression in tumor tissue.

Outcome measures

Outcome measures
Measure	Treatment (Pembrolizumab, Cryosurgery) n=2 Participants 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. Cryosurgery: Undergo whole gland cryoablation Degarelix: Given SC Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV
Expression of PD-L1	0 Participants

Adverse Events

Treatment (Pembrolizumab, Cryosurgery)

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment (Pembrolizumab, Cryosurgery) n=12 participants at risk 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. Cryosurgery: Undergo whole gland cryoablation Degarelix: Given SC Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV
Blood and lymphatic system disorders Edema	25.0% 3/12 • Number of events 3 • up to 2 years
Renal and urinary disorders Urinary incontinence	16.7% 2/12 • Number of events 2 • up to 2 years
Renal and urinary disorders Urinary urgency	25.0% 3/12 • Number of events 3 • up to 2 years
Reproductive system and breast disorders Erectile Dysfunction	8.3% 1/12 • Number of events 1 • up to 2 years
Blood and lymphatic system disorders Anemia	8.3% 1/12 • Number of events 1 • up to 2 years
Psychiatric disorders Depression	16.7% 2/12 • Number of events 2 • up to 2 years
General disorders Fatigue	66.7% 8/12 • Number of events 8 • up to 2 years
Vascular disorders Hot flashes	50.0% 6/12 • Number of events 6 • up to 2 years
Gastrointestinal disorders Nausea	8.3% 1/12 • Number of events 1 • up to 2 years
Renal and urinary disorders Bladder spasm	8.3% 1/12 • Number of events 1 • up to 2 years
Renal and urinary disorders Urinary frequency	25.0% 3/12 • Number of events 3 • up to 2 years
General disorders Injection site reaction	25.0% 3/12 • Number of events 3 • up to 2 years
Gastrointestinal disorders Oral pain	8.3% 1/12 • Number of events 1 • up to 2 years
Skin and subcutaneous tissue disorders Pruritis	16.7% 2/12 • Number of events 3 • up to 2 years
Gastrointestinal disorders Constipation	16.7% 2/12 • Number of events 2 • up to 2 years
Skin and subcutaneous tissue disorders Maculo-papular Rash	16.7% 2/12 • Number of events 3 • up to 2 years
Nervous system disorders Dysgeusia	16.7% 2/12 • Number of events 2 • up to 2 years
Nervous system disorders Headache	16.7% 2/12 • Number of events 2 • up to 2 years
Gastrointestinal disorders Mucositis	8.3% 1/12 • Number of events 2 • up to 2 years
Psychiatric disorders Insomnia	8.3% 1/12 • Number of events 1 • up to 2 years
Musculoskeletal and connective tissue disorders Pain	33.3% 4/12 • Number of events 5 • up to 2 years
Reproductive system and breast disorders Penile pain	8.3% 1/12 • Number of events 1 • up to 2 years
General disorders Chills	8.3% 1/12 • Number of events 1 • up to 2 years
Renal and urinary disorders Nocturia	8.3% 1/12 • Number of events 1 • up to 2 years
Gastrointestinal disorders Dry mouth	8.3% 1/12 • Number of events 1 • up to 2 years
Psychiatric disorders Agitation	8.3% 1/12 • Number of events 1 • up to 2 years
Respiratory, thoracic and mediastinal disorders Voice alteration	8.3% 1/12 • Number of events 1 • up to 2 years
Renal and urinary disorders Hematuria	16.7% 2/12 • Number of events 2 • up to 2 years
Skin and subcutaneous tissue disorders Skin induration	8.3% 1/12 • Number of events 1 • up to 2 years
Gastrointestinal disorders Abdominal Pain	8.3% 1/12 • Number of events 1 • up to 2 years
Gastrointestinal disorders Groin Pain	25.0% 3/12 • Number of events 3 • up to 2 years
Metabolism and nutrition disorders Night sweats	8.3% 1/12 • Number of events 1 • up to 2 years
Musculoskeletal and connective tissue disorders Pain, extremities	16.7% 2/12 • Number of events 2 • up to 2 years

Additional Information

Emmanuel Antonarakis, MD

Johns Hopkins University/Sidney Kimmel Cancer Center

Phone: 410-502-7528

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place