Cryotherapy for recurrent prostate cancer after radiation therapy
Salvage Cryotherapy for Recurrent Prostate Cancer After Brachytherapy or Radiotherapy
NA · University Hospital Virgen de las Nieves · NCT04891536
This study is testing if a treatment called cryotherapy can be a safe and effective option for men with prostate cancer that comes back after radiation therapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Male |
| Sponsor | University Hospital Virgen de las Nieves (other) |
| Drugs / interventions | radiation |
| Locations | 2 sites (Córdoba, Andalucía and 1 other locations) |
| Trial ID | NCT04891536 on ClinicalTrials.gov |
What this trial studies
This project aims to create a comprehensive protocol for a multicenter registry of patients undergoing salvage cryoablation of the prostate (SCAP) for local recurrence of prostate cancer after radiation therapy. The study hypothesizes that SCAP is a safe and effective alternative to salvage radical prostatectomy, potentially offering lower morbidity with comparable efficacy. A systematic review has shown promising 2-year and 5-year biochemical recurrence-free survival rates, but there is a significant need for more robust evidence regarding long-term outcomes and side effects. The study will address these gaps by collecting detailed histopathological data and patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically confirmed local recurrence of prostate cancer after radiation therapy, with no evidence of distant metastasis and specific clinical criteria.
Not a fit: Patients with clinically confirmed distant metastasis or significant urinary tract anomalies may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive treatment option for patients with recurrent prostate cancer, potentially improving their quality of life and treatment outcomes.
How similar studies have performed: While previous studies have shown promising results for salvage cryoablation, this study aims to fill significant gaps in the evidence base, making it a novel and necessary investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Córdoba, Andalucía and 1 other locations
- Hospital Universitario Reina Sofía — Córdoba, Andalucía, Spain (RECRUITING)
- Hospital Universitario Virgen de las Nieves — Granada, Andalucía, Spain (RECRUITING)
Study contacts
- Study coordinator: Enrique Gómez-Gómez
- Email: enriquegomezgomez@yahoo.es
- Phone: 958 56 76 65
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer, Cryotherapy, Recurrent Prostate Cancer, PSMA/PET-CT