SCAP vs HIFU for Recurrent Prostate Cancer After Radiation Therapy (SALVPROST)

University Hospital Virgen de las Nieves

Status: Enrolling

Conditions: Cryotherapy; High Intensity Focused Ultrasounds; Recurrent Prostate Cancer

Treatments: Procedure: Local treatment of the prostate (SCAP or HIFU)

Study type: Observational

Funder types: Other

Identifiers

NCT05044754

SALVPROST-YAU-21

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Male

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 2 patient groups

SCAP

Description:

Patients with recurrent prostate cancer undergoing SCAP

Treatment:

Procedure: Local treatment of the prostate (SCAP or HIFU)

HIFU

Description:

Patients with recurrent prostate cancer undergoing HIFU

Treatment:

Procedure: Local treatment of the prostate (SCAP or HIFU)