Prostate CancerCRIOAND2021NCT04891536
Salvage Cryotherapy for Recurrent Prostate Cancer After Radiation Therapy
A study testing Salvage cryoablation of the prostate (SCAP) in people with Prostate Cancer and Cryotherapy, run by Ignacio Puche Sanz at 2 sites in Spain.
Trial summary
The main objective of this project is to establish a shared comprehensive and systematic protocol for a multicenter prospective registry of patients undergoing salvage cryoablation of the prostate (SCAP). Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Prostate Cancer, Cryotherapy, Recurrent Prostate Cancer
- What is being tested?
- Salvage cryoablation of the prostate (SCAP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesSpain
- Study dates
- 1 May 2021to 1 May 2026
- Phase
- Interventional
- 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
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 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 ≤cT3a without affecting the bladder neck or the membranous urethra
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
2 sites in 1 country.
Spain2 sites, 2 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
About this study
Official title: Salvage Cryotherapy for Recurrent Prostate Cancer After Brachytherapy or Radiotherapy
The main objective of this project is to establish a shared comprehensive and systematic protocol for a multicenter prospective registry of patients undergoing salvage cryoablation of the prostate (SCAP).
Our study hypothesis is that SCAP constitutes an effective and safe approach to treat local prostate cancer recurrence after brachytherapy or external beam radiation therapy (EBRT).
Read the detailed description
Salvage cryoablation of the prostate has been proposed as an alternative to salvage radical prostatectomy, as it has a potentially lower risk of morbidity and equal efficacy. A recent systematic review assessed a total of 32 studies of SCAP (5.513 patients). The overwhelming majority of patients (93%) received whole-gland SCAP. The adjusted pooled analysis for 2-year BCR-free survival for SCAP was 67.49% (95% CI: 61.68-72.81%), and for 5-year BCR-free survival was 50.25% (95% CI: 44.10-56.40%).
Nevertheless, the evidence base relating to the use of SCAP is poor, with significant uncertainties relating to long-term oncological outcomes. One of the main limitations when these studies 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 only refer to biochemical-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.
Due to this lack of evidence, the EAU 2021 Guidelines recommend that SCAP should only be performed in selected patients in experienced centres as part of a clinical trial or well-designed prospective cohort study.
- Conditions
- Prostate Cancer, Cryotherapy, Recurrent Prostate Cancer
- Being tested
- Salvage cryoablation of the prostate (SCAP)
- Keywords
- PSMA/PET-CT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salvage cryoablation of the prostate (SCAP)Procedure or surgery
Cryotherapy of the prostate through transperineal freeezing needles
| Study group | Role | What they receive |
|---|---|---|
| Patients with histologically confirmed recurrent prostate cancer after primary radiation therapy | Experimental | Not described Receives: Procedure: Salvage cryoablation of the prostate (SCAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free rate
absence of disease in follow-up biopsy AND PET/PSMA
Measured: 1 year
ADT-free survival
Absence of androgen deprivation therapy need during follow-up
Measured: 5 years
Secondary outcomes (7)
Rate of incontinence
Measured by International Consultation on Incontienence Questionnaire short-form (ICIQ-SF)
Measured: 1 year
Rate of sexual disfunction
Measured by International Index Erectile Function (IIEF-25)
Measured: 1 year
Effect on urinary symptoms
Measured by International Prostate Symptoms Score (IPSS) and uroflowmetry
Measured: 1 year
Biochemical free survival
PSA
Measured: 5 years
Metastasis free survival
Metastasis detected in novel imaging modalities
Measured: 5 years
Performance of mpMRI and PET-CT for the detection of clinically significant recurrence.
Related to the histopathology observed
Measured: 1 year
Rate of metastasis detected by PET-CT
Metastais detected
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 posted18 May 2021
- Study start1 May 2021
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ignacio Puche Sanz
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Reina Sofia de Cordoba
- Responsible party
- Sponsor-investigator, Ignacio Puche Sanz, University Hospital Virgen de las Nieves
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891536
- Sponsor's protocol ID
- CRIOAND 0325-N-21
- Acronym
- CRIOAND2021
- Status last verified
- May 2021
- First submitted
- 9 May 2021
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salvage Cryotherapy for Recurrent Prostate Cancer After Brachytherapy or Radiotherapy
- ClinicalTrials.gov ID
- NCT04891536
- Acronym / sponsor ID
- CRIOAND2021 / CRIOAND 0325-N-21
- Conditions
- Prostate Cancer, Cryotherapy, Recurrent Prostate Cancer
- Keywords
- PSMA/PET-CT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ignacio Puche SanzUniversity, hospital or other
- Collaborators
- Hospital Universitario Reina Sofia de Cordoba
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 18 May 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 main objective of this project is to establish a shared comprehensive and systematic protocol for a multicenter prospective registry of patients undergoing salvage cryoablation of the prostate (SCAP).
Our study hypothesis is that SCAP constitutes an effective and safe approach to treat local prostate cancer recurrence after brachytherapy or external beam radiation therapy (EBRT).
Detailed description
Salvage cryoablation of the prostate has been proposed as an alternative to salvage radical prostatectomy, as it has a potentially lower risk of morbidity and equal efficacy. A recent systematic review assessed a total of 32 studies of SCAP (5.513 patients). The overwhelming majority of patients (93%) received whole-gland SCAP. The adjusted pooled analysis for 2-year BCR-free survival for SCAP was 67.49% (95% CI: 61.68-72.81%), and for 5-year BCR-free survival was 50.25% (95% CI: 44.10-56.40%).
Nevertheless, the evidence base relating to the use of SCAP is poor, with significant uncertainties relating to long-term oncological outcomes. One of the main limitations when these studies 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 only refer to biochemical-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.
Due to this lack of evidence, the EAU 2021 Guidelines recommend that SCAP should only be performed in selected patients in experienced centres as part of a clinical trial or well-designed prospective cohort study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with histologically confirmed recurrent prostate cancer after primary radiation therapy | Experimental | Procedure: Salvage cryoablation of the prostate (SCAP) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with local recurrence (with histological confirmation) after treatment with radiotherapy or brachytherapy without evidence of distant involvement evaluated 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 ≤cT3a without affecting the bladder neck or the membranous urethra
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 |
|---|---|---|
| Salvage cryoablation of the prostate (SCAP)Cryotherapy of the prostate through transperineal freeezing needles | Procedure or surgery | Patients with histologically confirmed recurrent prostate cancer after primary radiation therapy |
Primary outcome
Disease-free rate
Time frame: 1 year
absence of disease in follow-up biopsy AND PET/PSMA
ADT-free survival
Time frame: 5 years
Absence of androgen deprivation therapy need during follow-up
7 secondary outcomes
Rate of incontinence
Time frame: 1 year
Rate of sexual disfunction
Time frame: 1 year
Effect on urinary symptoms
Time frame: 1 year
Biochemical free survival
Time frame: 5 years
Metastasis free survival
Time frame: 5 years
Performance of mpMRI and PET-CT for the detection of clinically significant recurrence.
Time frame: 1 year
Rate of metastasis detected by PET-CT
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 18 May 2021.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salvage cryoablation of the prostate (SCAP) in people with Prostate Cancer and Cryotherapy, run by Ignacio Puche Sanz at 2 sites in Spain.
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 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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 Enrique Gómez-Gómez (958 56 76 65, enriquegomezgomez@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free rate (time frame: 1 year). The study lists 2 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 18 May 2021.