NCT05044754

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2021

Typical duration for all trials

Geographic Reach
2 countries

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 16, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

2 years

First QC Date

September 1, 2021

Last Update Submit

September 5, 2021

Conditions

CryotherapyHigh Intensity Focused UltrasoundsRecurrent Prostate Cancer

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (6)

  • BCR free survival

    5 years

  • MFS-PET

    5 years f-u

  • Complications rate

    1 year

  • Continence

    1 year

  • Sexual function

    1 year

  • +1 more secondary outcomes

Study Arms (2)

SCAP

Patients with recurrent prostate cancer undergoing SCAP

Procedure: 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)

Interventions

Local treatment of the prostate (SCAP or HIFU)PROCEDURE

Once the local involvement of the recurrent prostate cancer is confirmed, patient will undergo local treatment of the prostate (SCAP or HIFU)

HIFUSCAP

Eligibility Criteria

Age18 Years - 90 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Institut Universitaire du Cancer

Toulouse, France

RECRUITING

Hospital Universitario Reina Sofía

Córdoba, Andalusia, Spain

RECRUITING

Hospital Universitario Virgen de las Nieves

Granada, Andalusia, Spain

RECRUITING

Hospital Universitario Virgen del Rocio

Seville, Spain

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

SREBP cleavage-activating protein

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Ignacio Puche-Sanz, MD, PhD

    University Hospital Virgen de las Nieves

    PRINCIPAL INVESTIGATOR

  • Enrique Gomez-Gomez, MD

    Hospital Universitario Reina Sofia de Cordoba

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ignacio Puche Sanz, MD PhD

CONTACT

0034 958 02 00 00nacho.puchesanz@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD Urologist

Study Record Dates

First Submitted

September 1, 2021

First Posted

September 16, 2021

Study Start

October 1, 2021

Primary Completion

October 1, 2023

Study Completion

October 1, 2024

Last Updated

September 16, 2021

Record last verified: 2021-09

Locations

FR(1)ES(3)