SALVPROST: SCAP vs HIFU for Recurrent Prostate Cancer After Radiation Therapy

• Sponsor: University Hospital Virgen de las Nieves (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05044754
• Collaborator: Hospital Universitario Reina Sofia de Cordoba (Other), Hospitales Universitarios Virgen del Rocío (Other), Institut Universitaire du Cancer - Oncopole. Toulose. France (Other)
• Enrollment: 50
• Locations: 4
• Anticipated Duration (Months): 36
• Patients Per Site: 12.5
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cryotherapy; High Intensity Focused Ultrasounds; Recurrent Prostate Cancer	Procedure: Local treatment of the prostate (SCAP or HIFU)

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Salvage Cryoablation of the Prostate (SCAP) vs High Intensity Focal Ultrasounds (HIFU) for Recurrent Prostate Cancer After Radiation Therapy
• Anticipated Study Start Date: Oct 1, 2021
• Anticipated Primary Completion Date: Oct 1, 2023
• Anticipated Study Completion Date: Oct 1, 2024

Arms and Interventions

Arm	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)

Outcome Measures

Primary Outcome Measures

1. DFS-histology [1 year]

   Disease free survival (confirmed by follow-up biopsy)

2. DFS-image [1 year]

   Disease free survival (confirmed by follow-up PET-CT )

3. ADT-FS [5 years]

   Androgen deprivation therapy free survival.

Secondary Outcome Measures

1. BCR free survival [5 years]

   Time free of biochemical recurrence (PSA)

2. MFS-PET [5 years f-u]

   Metastasis free survival. rate of patients without any metastasis detected on PET-CT.

3. Complications rate [1 year]

   Rate of early and long-term complications

4. Continence [1 year]

   Change in continence scores (ICIQ-SF q)

5. Sexual function [1 year]

   Changes in sexual function (IIEF questionanaire)

6. Low urinary tract function [1 year]

   Changes in IPSS questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: Male
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Universitaire du Cancer	Toulouse		France
2	Hospital Universitario Reina Sofía	Córdoba	Andalucía	Spain
3	Hospital Universitario Virgen de las Nieves	Granada	Andalucía	Spain
4	Hospital Universitario Virgen del Rocio	Seville		Spain

Sponsors and Collaborators

• University Hospital Virgen de las Nieves
• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ignacio Puche Sanz, MD PhD Urologist, University Hospital Virgen de las Nieves
• ClinicalTrials.gov Identifier: NCT05044754
• Other Study ID Numbers: SALVPROST-YAU-21
• First Posted: Sep 16, 2021
• Last Update Posted: Sep 16, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prostatic Neoplasms; Recurrence

Study Results

No Results Posted as of Sep 16, 2021