Clinical trial NCT05044754: SCAP vs HIFU for Recurrent Prostate Cancer After Radiation Therapy
Official title: Salvage Cryoablation of the Prostate (SCAP) vs High Intensity Focal Ultrasounds (HIFU) for Recurrent Prostate Cancer After Radiation Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cryotherapy
High Intensity Focused Ultrasounds
Recurrent Prostate Cancer
Lead sponsor: University Hospital Virgen de las Nieves
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Reina Sofia de Cordoba
name: Hospitales Universitarios Virgen del Rocío
name: Institut Universitaire du Cancer de Toulouse
First posted: 2021-09-16
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering local recurrence of prostate cancer after primary treatment with radiation therapy

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.


Eligibility criteria: 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

Primary outcomes:
measure: DFS-histology
timeFrame: 1 year
measure: DFS-image
timeFrame: 1 year
measure: ADT-FS
timeFrame: 5 years
Secondary outcomes:
measure: BCR free survival
timeFrame: 5 years
measure: MFS-PET
timeFrame: 5 years f-u
measure: Complications rate
timeFrame: 1 year
measure: Continence
timeFrame: 1 year
measure: Sexual function
timeFrame: 1 year
measure: Low urinary tract function
timeFrame: 1 year
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Institut Universitaire du Cancer
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
state: Andalucía
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
state: Andalucía
city: Seville
country: Spain
facility: Hospital Universitario Virgen del Rocio
Study officials:
affiliation: University Hospital Virgen de las Nieves
name: Ignacio Puche-Sanz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Reina Sofia de Cordoba
name: Enrique Gomez-Gomez, MD
role: PRINCIPAL_INVESTIGATOR
References: