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NCT Number: NCT04138914

Phase II Trial of Focal Cryotherapy for Prostate Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Singapore General Hospital

Singapore, 168753

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Focal Cryotherapy

Device

Ablation of the cancer focus within the prostate using cryotherapy

Other names: Focal Therapy, Focal Cryoablation

Primary outcomes

  1. 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

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

    Time frame: at 3 months

Secondary outcomes

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

    Time frame: at 12 months

Other outcomes

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

    Time frame: up to 10 years

  2. Metastatic Rate as measured by Bone Scan, CT or mpMRI

    Time frame: up to 10 years

  3. Death Rate

    Time frame: up to 10 years

Sponsors and collaborators

Lead sponsor

Singapore General Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2041
First posted
Oct 25, 2019
Registry last updated
Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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