Phase II Trial of Focal Cryotherapy for Prostate Cancer

Sponsor
Singapore General Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04138914
Collaborator
(none)
30
1
1
264
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Focal Cryotherapy
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Trial of Focal Cryotherapy for Prostate Cancer
Actual Study Start Date :
Mar 1, 2019
Actual Primary Completion Date :
Jan 31, 2021
Anticipated Study Completion Date :
Mar 1, 2041

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. 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]

    2. Number of Participants with Treatment-Related Adverse Events assessed by the Clavien-Dindo Scale [at 3 months]

    Secondary Outcome Measures

    1. Infield (focally treated area) and Outfield (untreated area) positive biopsy rate at 12 months [at 12 months]

    Other Outcome Measures

    1. Local Progression Rate as measured by follow-up mpMRI (multi parametric magnetic resonance imaging) [up to 10 years]

    2. Metastatic Rate as measured by Bone Scan, CT or mpMRI [up to 10 years]

    3. Death Rate [up to 10 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Singapore General Hospital Singapore Singapore 168753

    Sponsors and Collaborators

    • Singapore General Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Singapore General Hospital
    ClinicalTrials.gov Identifier:
    NCT04138914
    Other Study ID Numbers:
    • 2018/2482
    First Posted:
    Oct 25, 2019
    Last Update Posted:
    Oct 1, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 1, 2021