N/A
N=12
Pembrolizumab and Cryosurgery in Treating Patients With Newly Diagnosed, Oligo-metastatic Prostate Cancer
Stage IV Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02489357 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Number of Participants With PSA < 0.6 ng/mL — 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cryosurgery (Procedure); Degarelix (Drug); Laboratory Biomarker Analysis (Other); Pembrolizumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With PSA < 0.6 ng/mL |
5 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Have histologically or cytologically diagnosed oligo-metastatic prostate cancer; oligo-metastatic disease is defined to reflect men with low volume disease; specifically, oligo-metastatic disease is defined as less than 5 extra-pelvic metastases; metastatic lesions may be lymph nodes
- Be willing and able to provide written informed consent/assent for the trial
- Have available tissue from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion
- Eastern Cooperative Oncology Group (ECOG) performance scale status of 0 or 1
- Demonstrate adequate organ function, all screening labs should be performed within 14 days of treatment initiation
- Absolute neutrophil count (ANC) >= 1,500/mcL
- Platelets >= 100,000/mcL
- Hemoglobin >= 9 g/dL or >= 5.6 mmol/L
- Serum creatinine OR measured or calculated creatinine clearance (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]) = = 60 mL/min for subject with creatinine levels > 1.5 X institutional upper limit of normal (ULN)
- Serum total bilirubin = 1.5 ULN
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) = 20) or urinary retention requiring a catheter
- Has contraindications to cryotherapy of the prostate, including: previous transurethral prostatic resection (TURP) with persistent transurethral resection (TUR) defect, existing peri-anal or recto-urethral fistula, previous external beam radiation therapy or brachytherapy, coagulopathy, inability to tolerate anesthesia (spinal or general), inability to tolerate transrectal ultrasound (i.e. history of previous abdominal perineal resection)
Data sourced from ClinicalTrials.gov (NCT02489357). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.