Phase II Trial of Focal Cryotherapy for Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Phase II Trial of Focal Cryotherapy for Prostate Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04138914
• Other study ID #: 2018/2482
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: March 2041

Study information

• Verified date: April 2023
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: March 2041
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• Focal Cryotherapy
Ablation of the cancer focus within the prostate using cryotherapy

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Local Progression Rate as measured by follow-up mpMRI (multi parametric magnetic resonance imaging)		up to 10 years
Other	Metastatic Rate as measured by Bone Scan, CT or mpMRI		up to 10 years
Other	Death Rate		up to 10 years
Primary	Mean change in EPIC (Expanded Prostate Composite Index) subdomain score at 1, 3, 6, 12 months compared to baseline		1,3,6 and 12 months
Primary	Number of Participants with Treatment-Related Adverse Events assessed by the Clavien-Dindo Scale		at 3 months
Secondary	Infield (focally treated area) and Outfield (untreated area) positive biopsy rate at 12 months		at 12 months