Prostate Cancer
Conditions
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.
Interventions
DEVICEFocal Cryotherapy
Ablation of the cancer focus within the prostate using cryotherapy
Sponsors
Singapore General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| Number of Participants with Treatment-Related Adverse Events assessed by the Clavien-Dindo Scale | at 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Infield (focally treated area) and Outfield (untreated area) positive biopsy rate at 12 months | at 12 months |
Other
| Measure | Time frame |
|---|---|
| Local Progression Rate as measured by follow-up mpMRI (multi parametric magnetic resonance imaging) | up to 10 years |
| Metastatic Rate as measured by Bone Scan, CT or mpMRI | up to 10 years |
| Death Rate | up to 10 years |
Countries
Singapore
Outcome results
None listed