Phase II Trial of Focal Cryotherapy for Prostate Cancer

Singapore Health Services (SingHealth)

Status: Active, not recruiting

Conditions: Prostate Cancer

Treatments: Device: Focal Cryotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04138914

2018/2482

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Focal Cryotherapy

Experimental group

Description:

Focal Cryotherapy using 2 freeze-thaw cycles

Treatment:

Device: Focal Cryotherapy