Phase II Trial of Focal Cryotherapy for Prostate Cancer

NCT04138914 | Active Not Recruiting FDA Device

• 1 other identifier: 2018/2482
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• Number of Participants with Treatment-Related Adverse Events assessed by the Clavien-Dindo Scale

  at 3 months

Secondary Outcomes (1)

• Infield (focally treated area) and Outfield (untreated area) positive biopsy rate at 12 months

  at 12 months

Other Outcomes (3)

• Local Progression Rate as measured by follow-up mpMRI (multi parametric magnetic resonance imaging)

  up to 10 years

• Metastatic Rate as measured by Bone Scan, CT or mpMRI

  up to 10 years

• Death Rate

  up to 10 years

Study Arms (1)

Focal Cryotherapy

EXPERIMENTAL

Focal Cryotherapy using 2 freeze-thaw cycles

Device: Focal Cryotherapy

Interventions

Focal Cryotherapy DEVICE

Ablation of the cancer focus within the prostate using cryotherapy

Also known as: Focal Therapy, Focal Cryoablation

Focal Cryotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, 168753, Singapore

Location

Related Publications (6)

• 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.

  PMID: 28349978 BACKGROUND

• 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.

  PMID: 28385075 BACKGROUND

• 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.

  PMID: 28654336 BACKGROUND

• 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.

  PMID: 29948045 BACKGROUND

• 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.

  PMID: 22445223 BACKGROUND

• Tan YG, Law YM, Ngo NT, Khor LY, Tan PH, Ong EHW, Yuen JSP, Ho HSS, Tuan JKL, Kanesvaran R, Gupta RT, Rozen S, Chua MLK, Polascik TJ, Tay KJ. Patient-reported functional outcomes and oncological control after primary focal cryotherapy for clinically significant prostate cancer: A Phase II mandatory biopsy-monitored study. Prostate. 2023 Jun;83(8):781-791. doi: 10.1002/pros.24517. Epub 2023 Mar 9.

  PMID: 36895163 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Kae Jack Tay, MBBS

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: October 25, 2019
• Study Start: March 1, 2019
• Primary Completion: January 31, 2021
• Study Completion (Estimated): March 1, 2041
• Last Updated: April 4, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)