CryotherapySALVPROSTNCT05044754
SCAP vs HIFU for Recurrent Prostate Cancer After Radiation Therapy
An observational study of Cryotherapy and High Intensity Focused Ultrasounds, run by University Hospital Virgen de las Nieves at 4 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Cryotherapy, High Intensity Focused Ultrasounds, Recurrent Prostate Cancer
- What is being tested?
- Local treatment of the prostate (SCAP or HIFU)
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 Oct 2021to 1 Oct 2024
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering local recurrence of prostate cancer after primary treatment with radiation therapy
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Spain3 sites, 3 recruiting
- Recruiting
Hospital Universitario Reina Sofía
Córdoba, Andalusia
Enrique Gómez-Gómez, 958 56 76 65, enriquegomezgomez@yahoo.es
Enrique Gómez-Gómez
- Recruiting
Hospital Universitario Virgen de las Nieves
Granada, Andalusia
Ignacio Puche-Sanz, 958 67 56 37, nacho.puchesanz@gmail.com
Ignacio Puche-Sanz
- Recruiting
Hospital Universitario Virgen del Rocio
Seville
Ignacio Osman, +0034 955 01 20 00, nachosman79@hotmail.com
France1 site, 1 recruiting
- Recruiting
Institut Universitaire du Cancer
Toulouse
Guillaume Ploussard, MD PhD, +33 5 31 15 50 50, g.ploussard@gmail.com
About this study
Official title: 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.
- Being tested
- Local treatment of the prostate (SCAP or HIFU)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local treatment of the prostate (SCAP or HIFU)Procedure or surgery
Once the local involvement of the recurrent prostate cancer is confirmed, patient will undergo local treatment of the prostate (SCAP or HIFU)
| Study group | Role | What they receive |
|---|---|---|
| SCAP | Patients with recurrent prostate cancer undergoing SCAP Receives: Procedure: Local treatment of the prostate (SCAP or HIFU) | |
| HIFU | Patients with recurrent prostate cancer undergoing HIFU Receives: Procedure: Local treatment of the prostate (SCAP or HIFU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS-histology
Disease free survival (confirmed by follow-up biopsy)
Measured: 1 year
DFS-image
Disease free survival (confirmed by follow-up PET-CT )
Measured: 1 year
ADT-FS
Androgen deprivation therapy free survival.
Measured: 5 years
Secondary outcomes (6)
BCR free survival
Time free of biochemical recurrence (PSA)
Measured: 5 years
MFS-PET
Metastasis free survival. rate of patients without any metastasis detected on PET-CT.
Measured: 5 years f-u
Complications rate
Rate of early and long-term complications
Measured: 1 year
Continence
Change in continence scores (ICIQ-SF q)
Measured: 1 year
Sexual function
Changes in sexual function (IIEF questionanaire)
Measured: 1 year
Low urinary tract function
Changes in IPSS questionnaire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start1 Oct 2021 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CryotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Hospital Virgen de las Nieves
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Reina Sofia de Cordoba, Hospitales Universitarios Virgen del Rocío, Institut Universitaire du Cancer de Toulouse
- Responsible party
- Principal investigator, Ignacio Puche Sanz, University Hospital Virgen de las Nieves
- Investigators
- Ignacio Puche-Sanz, MD, PhD, Principal investigator, University Hospital Virgen de las NievesEnrique Gomez-Gomez, MD, Principal investigator, Hospital Universitario Reina Sofia de Cordoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044754
- Sponsor's protocol ID
- SALVPROST-YAU-21
- Acronym
- SALVPROST
- Status last verified
- Sep 2021
- First submitted
- 1 Sep 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salvage Cryoablation of the Prostate (SCAP) vs High Intensity Focal Ultrasounds (HIFU) for Recurrent Prostate Cancer After Radiation Therapy
- ClinicalTrials.gov ID
- NCT05044754
- Acronym / sponsor ID
- SALVPROST / SALVPROST-YAU-21
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital Virgen de las NievesUniversity, hospital or other
- Collaborators
- Hospital Universitario Reina Sofia de Cordoba, Hospitales Universitarios Virgen del Rocío, Institut Universitaire du Cancer de Toulouse
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCAP | – | Procedure: Local treatment of the prostate (SCAP or HIFU)Patients with recurrent prostate cancer undergoing SCAP |
| HIFU | – | Procedure: Local treatment of the prostate (SCAP or HIFU)Patients with recurrent prostate cancer undergoing HIFU |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering local recurrence of prostate cancer after primary treatment with radiation therapy
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Procedure or surgery | HIFU, SCAP |
Primary outcome
DFS-histology
Time frame: 1 year
Disease free survival (confirmed by follow-up biopsy)
DFS-image
Time frame: 1 year
Disease free survival (confirmed by follow-up PET-CT )
ADT-FS
Time frame: 5 years
Androgen deprivation therapy free survival.
6 secondary outcomes
BCR free survival
Time frame: 5 years
MFS-PET
Time frame: 5 years f-u
Complications rate
Time frame: 1 year
Continence
Time frame: 1 year
Sexual function
Time frame: 1 year
Low urinary tract function
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ignacio Puche-Sanz, MD, PhD principal investigator
University Hospital Virgen de las Nieves
Enrique Gomez-Gomez, MD principal investigator
Hospital Universitario Reina Sofia de Cordoba
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cryotherapy and High Intensity Focused Ultrasounds, run by University Hospital Virgen de las Nieves at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ignacio Puche Sanz, MD PhD (0034 958 02 00 00, nacho.puchesanz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFS-histology (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.