Cryotherapy, High Intensity Focused Ultrasounds, Recurrent Prostate Cancer
Conditions
Brief summary
The evidence base relating to the use of SCAP and HIFU is poor, with significant uncertainties relating to long-term oncological outcomes. One of the main limitations when the few studies reported are analyzed is the lack of information about the histopathology both before starting treatment and at the time of recurrence after cryotherapy. The vast majority of studies refer only to BCR-free survival as end point, thus limiting interpretation of real oncological performance of this technique. Furthermore, side effects vary widely from study to study and there are uncertainties about the real morbidity associated to cryotherapy in the salvage setting. Another important hot issue in this scenario is the potential benefit that new imaging and diagnosis techniques (MRI, targeted biopsy, PSMA) may add for a more accurate indication. This could provide the possibility of better results for SCAP. The clinical value of this new diagnostic tools is unknown in this scenario and needs to be explored.
Interventions
PROCEDURELocal treatment of the prostate (SCAP or HIFU)
Once the local involvement of the recurrent prostate cancer is confirmed, patient will undergo local treatment of the prostate (SCAP or HIFU)
Sponsors
Hospital Universitario Reina Sofia de Cordoba
Hospitales Universitarios Virgen del Rocío
Institut Universitaire du Cancer de Toulouse
University Hospital Virgen de las Nieves
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients with local recurrence (with histological confirmation) after treatment with radiotherapy or brachytherapy without evidence of distant involvement evaluated preferably 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 (template suppl 1) o mpMRI ≤cT3a without affecting the bladder neck or the membranous urethra so that the continence mechanisms of the sphincter are not compromised.
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DFS-histology | 1 year | Disease free survival (confirmed by follow-up biopsy) |
| DFS-image | 1 year | Disease free survival (confirmed by follow-up PET-CT ) |
| ADT-FS | 5 years | Androgen deprivation therapy free survival. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Continence | 1 year | Change in continence scores (ICIQ-SF q) |
| BCR free survival | 5 years | Time free of biochemical recurrence (PSA) |
| Low urinary tract function | 1 year | Changes in IPSS questionnaire |
| Sexual function | 1 year | Changes in sexual function (IIEF questionanaire) |
| MFS-PET | 5 years f-u | Metastasis free survival. rate of patients without any metastasis detected on PET-CT. |
| Complications rate | 1 year | Rate of early and long-term complications |
Countries
France, Spain
Contacts
Primary ContactIgnacio Puche Sanz, MD PhD
Outcome results
None listed