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

Salvage Cryoablation of the Prostate (SCAP) vs High Intensity Focal Ultrasounds (HIFU) for Recurrent Prostate Cancer After Radiation Therapy

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.

Study Overview

• Status: Recruiting
• Conditions: Recurrent Prostate Cancer; Cryotherapy; High Intensity Focused Ultrasounds
• Intervention / Treatment: Procedure: Local treatment of the prostate (SCAP or HIFU)

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Ignacio Puche Sanz, MD PhD; Phone Number: 0034 958 02 00 00; Email: nacho.puchesanz@gmail.com

Study Locations

• France
  • Toulouse, France
    • Recruiting
    • Institut universitaire du cancer
    • Contact: Guillaume Ploussard, MD PhD; Phone Number: +33 5 31 15 50 50; Email: g.ploussard@gmail.com
• Spain
  • Seville, Spain
    • Recruiting
    • Hospital Universitario Virgen del Rocio
    • Contact: Ignacio Osman; Phone Number: +0034 955 01 20 00; Email: nachosman79@hotmail.com
  • Andalucía
    • Córdoba, Andalucía, Spain
      • Recruiting
      • Hospital Universitario Reina Sofia
      • Contact: Enrique Gómez-Gómez; Phone Number: 958 56 76 65; Email: enriquegomezgomez@yahoo.es
      • Principal Investigator: Enrique Gómez-Gómez
    • Granada, Andalucía, Spain
      • Recruiting
      • Hospital Universitario Virgen de las Nieves
      • Contact: Ignacio Puche-Sanz; Phone Number: 958 67 56 37; Email: nacho.puchesanz@gmail.com
      • Principal Investigator: Ignacio Puche-Sanz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Patients suffering local recurrence of prostate cancer after primary treatment with radiation therapy

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SCAP; Patients with recurrent prostate cancer undergoing SCAP	Procedure: Local 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)
HIFU; Patients with recurrent prostate cancer undergoing HIFU	Procedure: Local 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DFS-histology	Disease free survival (confirmed by follow-up biopsy)	1 year
DFS-image	Disease free survival (confirmed by follow-up PET-CT )	1 year
ADT-FS	Androgen deprivation therapy free survival.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BCR free survival	Time free of biochemical recurrence (PSA)	5 years
MFS-PET	Metastasis free survival. rate of patients without any metastasis detected on PET-CT.	5 years f-u
Complications rate	Rate of early and long-term complications	1 year
Continence	Change in continence scores (ICIQ-SF q)	1 year
Sexual function	Changes in sexual function (IIEF questionanaire)	1 year
Low urinary tract function	Changes in IPSS questionnaire	1 year

Collaborators and Investigators

• Sponsor: University Hospital Virgen de las Nieves
• Collaborators: Hospital Universitario Reina Sofia de Cordoba; Hospitales Universitarios Virgen del Rocío; Institut Universitaire du Cancer - Oncopole. Toulose. France
• Investigators: Principal Investigator: Ignacio Puche-Sanz, MD, PhD, University Hospital Virgen de las Nieves; Principal Investigator: Enrique Gomez-Gomez, MD, Hospital Universitario Reina Sofia de Cordoba

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): October 1, 2024

Study Registration Dates

• First Submitted: September 1, 2021
• First Submitted That Met QC Criteria: September 5, 2021
• First Posted (Actual): September 16, 2021

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 5, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Disease Attributes; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Recurrence
• Other Study ID Numbers: SALVPROST-YAU-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No