Salvage Cryotherapy for Recurrent Prostate Cancer After Radiation Therapy

Launched by IGNACIO PUCHE SANZ · May 17, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called salvage cryotherapy for men with recurrent prostate cancer after they have already received radiation therapy. The goal of the trial is to see if salvage cryotherapy, which involves freezing the prostate tissue to destroy cancer cells, is a safe and effective way to treat cancer that comes back in the prostate area.

To participate in this trial, men between the ages of 65 and 74 who have a confirmed local recurrence of prostate cancer (meaning the cancer has returned but hasn't spread to other parts of the body) may be eligible. They should also have a life expectancy of more than 10 years, a prostate volume of less than 100cc, and a prostate-specific antigen (PSA) level of less than 10 ng/mL. Throughout the trial, participants will receive close monitoring and support as they undergo the salvage cryotherapy treatment. It’s important to note that men with confirmed cancer spread to other areas, major rectal surgery history, or certain urinary and rectal issues are not eligible for this study.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Patients with local recurrence (with histological confirmation) after treatment with radiotherapy or brachytherapy without evidence of distant involvement evaluated with PET/PSMA (if not available then Fluciclovine PET/CT or choline PET/CT must be performed).
• • Life expectancy \>10 years
• • Prostate volume \< 100cc
• • PSA\<10 ng/mL
• • mpMRI + fusion/systematic biopsy ≤cT3a without affecting the bladder neck or the membranous urethra
• Exclusion Criteria:
• • Patients with clinically confirmed distant metastasis
• • Any previous major rectal surgery
• • Clinically significant lower urinary tract or rectal anomalies
• • Existing urethral, rectal, or bladder fistulae