Clinical trial NCT04138914: Phase II Trial of Focal Cryotherapy for Prostate Cancer
Official title: Phase II Trial of Focal Cryotherapy for Prostate Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The current standard of care treatment for prostate cancer confined to the prostate is surgical removal or irradiation of the entire prostate gland. This is effective at curing cancer but result in damage to critical adjacent structures such as the urinary sphincter muscle and erectile nerves resulting in impaired urinary continence and erectile dysfunction. The concept of focal therapy is to treat just the dangerous focus of cancer in the prostate while monitoring the rest of the gland, thus avoiding impairment of urinary continence and erectile function. We aim to evaluate the degree of preservation of continence and erectile function and early oncological outcomes in patients undergoing focal therapy of the prostate using cold energy or cryo- ablation. In this study, we seek to evaluate patient reported outcomes in urinary, sexual, bowel and general health areas at fixed time points after focal cryo-ablation in selected patients with low-volume, localized cancer. The primary goal of this study is to demonstrate whether there is a deterioration of scores in these health areas over 1 year of follow-up. The secondary goal is to measure cancer control at 1 year re-biopsy. Further goals include longer follow-up to monitor cancer progression rates and impact on patient survival.


Eligibility criteria: Inclusion criteria:

* PSA (prostate specific antigen) ≤ 20
* Biopsy Gleason score ≤ 4+4
* mpMRI shows no gross extracapsular extension
* mpMRI shows index lesion volume \< 3 ml
* ≤ 2 biopsy confirmed lesions on mpMRI

Exclusion criteria:

* American Society of Anesthesiologist score \>3
* Very high grade cancer (Gleason score \> 4+4)
* \>2 index lesions
* Multifocal cancer (any other Gleason \>3+3 present and/or Gleason 3+3 at \> 3 biopsy cores at another site) - Not eligible for mpMRI
* Not fit for robotic transperineal saturation biopsy

Primary outcomes:
measure: Mean change in EPIC (Expanded Prostate Composite Index) subdomain score at 1, 3, 6, 12 months compared to baseline
timeFrame: 1,3,6 and 12 months
measure: Number of Participants with Treatment-Related Adverse Events assessed by the Clavien-Dindo Scale
timeFrame: at 3 months
Secondary outcomes:
measure: Infield (focally treated area) and Outfield (untreated area) positive biopsy rate at 12 months
timeFrame: at 12 months
Other outcomes:
measure: Local Progression Rate as measured by follow-up mpMRI (multi parametric magnetic resonance imaging)
timeFrame: up to 10 years
measure: Metastatic Rate as measured by Bone Scan, CT or mpMRI
timeFrame: up to 10 years
measure: Death Rate
timeFrame: up to 10 years
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Kae Jack Tay, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tay KJ, Scheltema MJ, Ahmed HU, Barret E, Coleman JA, Dominguez-Escrig J, Ghai S, Huang J, Jones JS, Klotz LH, Robertson CN, Sanchez-Salas R, Scionti S, Sivaraman A, de la Rosette J, Polascik TJ. Patient selection for prostate focal therapy in the era of active surveillance: an International Delphi Consensus Project. Prostate Cancer Prostatic Dis. 2017 Sep;20(3):294-299. doi: 10.1038/pcan.2017.8. Epub 2017 Mar 28.
citation: Tay KJ, Polascik TJ, Elshafei A, Tsivian E, Jones JS. Propensity Score-Matched Comparison of Partial to Whole-Gland Cryotherapy for Intermediate-Risk Prostate Cancer: An Analysis of the Cryo On-Line Data Registry Data. J Endourol. 2017 Jun;31(6):564-571. doi: 10.1089/end.2016.0830.
citation: Tay KJ, Cheng CWS, Lau WKO, Khoo J, Thng CH, Kwek JW. Focal Therapy for Prostate Cancer with In-Bore MR-guided Focused Ultrasound: Two-Year Follow-up of a Phase I Trial-Complications and Functional Outcomes. Radiology. 2017 Nov;285(2):620-628. doi: 10.1148/radiol.2017161650. Epub 2017 Jun 26.
citation: Tay KJ, Amin MB, Ghai S, Jimenez RE, Kench JG, Klotz L, Montironi R, Muto S, Rastinehad AR, Turkbey B, Villers A, Polascik TJ. Surveillance after prostate focal therapy. World J Urol. 2019 Mar;37(3):397-407. doi: 10.1007/s00345-018-2363-y. Epub 2018 Jun 9.
citation: Bahn D, de Castro Abreu AL, Gill IS, Hung AJ, Silverman P, Gross ME, Lieskovsky G, Ukimura O. Focal cryotherapy for clinically unilateral, low-intermediate risk prostate cancer in 73 men with a median follow-up of 3.7 years. Eur Urol. 2012 Jul;62(1):55-63. doi: 10.1016/j.eururo.2012.03.006. Epub 2012 Mar 21.