Phase II Trial of Focal Cryotherapy for Prostate Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2041-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Focal Cryotherapy

Focal Cryotherapy using 2 freeze-thaw cycles

Group Type EXPERIMENTAL

Focal Cryotherapy

Intervention Type DEVICE

Ablation of the cancer focus within the prostate using cryotherapy

Interventions

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Focal Cryotherapy

Ablation of the cancer focus within the prostate using cryotherapy

Intervention Type DEVICE

Other Intervention Names

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Focal Therapy Focal Cryoablation

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No