Phase II Trial of Focal Cryotherapy for Prostate Cancer

April 3, 2023 updated by: Singapore General Hospital
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 168753
        • Singapore General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Focal Cryotherapy
Focal Cryotherapy using 2 freeze-thaw cycles
Device: Focal Cryotherapy
Ablation of the cancer focus within the prostate using cryotherapy
Other Names:
  • Focal Therapy
  • Focal Cryoablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in EPIC (Expanded Prostate Composite Index) subdomain score at 1, 3, 6, 12 months compared to baseline
Time Frame: 1,3,6 and 12 months
1,3,6 and 12 months
Number of Participants with Treatment-Related Adverse Events assessed by the Clavien-Dindo Scale
Time Frame: at 3 months
at 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Infield (focally treated area) and Outfield (untreated area) positive biopsy rate at 12 months
Time Frame: at 12 months
at 12 months

Other Outcome Measures

Outcome Measure
Time Frame
Local Progression Rate as measured by follow-up mpMRI (multi parametric magnetic resonance imaging)
Time Frame: up to 10 years
up to 10 years
Metastatic Rate as measured by Bone Scan, CT or mpMRI
Time Frame: up to 10 years
up to 10 years
Death Rate
Time Frame: up to 10 years
up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Singapore General Hospital

Investigators

  • Principal Investigator: Kae Jack Tay, MBBS, Singapore General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Actual)

January 31, 2021

Study Completion (Anticipated)

March 1, 2041

Study Registration Dates

First Submitted

October 23, 2019

First Submitted That Met QC Criteria

October 23, 2019

First Posted (Actual)

October 25, 2019

Study Record Updates

Last Update Posted (Actual)

April 4, 2023

Last Update Submitted That Met QC Criteria

April 3, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/2482

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Clinical Trials on Focal Cryotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe