SCAP vs HIFU for Recurrent Prostate Cancer After Radiation Therapy

Recurrent Prostate Cancer Clinical Trial

— SALVPROST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05044754
• Other study ID #: SALVPROST-YAU-21
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: October 1, 2024

Study information

• Verified date: September 2021
• Source: University Hospital Virgen de las Nieves
• Contact: Ignacio Puche Sanz, MD PhD
• Phone: 0034 958 02 00 00
• Email: nacho.puchesanz[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cryotherapy
• Prostatic Neoplasms
• Recurrent Prostate Cancer

Intervention

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)

Locations

Country	Name	City	State
France	Institut Universitaire du Cancer	Toulouse
Spain	Hospital Universitario Reina Sofía	Córdoba	Andalucía
Spain	Hospital Universitario Virgen de las Nieves	Granada	Andalucía
Spain	Hospital Universitario Virgen del Rocio	Seville

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital Virgen de las Nieves	Hospital Universitario Reina Sofia de Cordoba, Hospitales Universitarios Virgen del Rocío, Institut Universitaire du Cancer - Oncopole. Toulose. France

Countries where clinical trial is conducted

France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DFS-histology	Disease free survival (confirmed by follow-up biopsy)	1 year
Primary	DFS-image	Disease free survival (confirmed by follow-up PET-CT )	1 year
Primary	ADT-FS	Androgen deprivation therapy free survival.	5 years
Secondary	BCR free survival	Time free of biochemical recurrence (PSA)	5 years
Secondary	MFS-PET	Metastasis free survival. rate of patients without any metastasis detected on PET-CT.	5 years f-u
Secondary	Complications rate	Rate of early and long-term complications	1 year
Secondary	Continence	Change in continence scores (ICIQ-SF q)	1 year
Secondary	Sexual function	Changes in sexual function (IIEF questionanaire)	1 year
Secondary	Low urinary tract function	Changes in IPSS questionnaire	1 year