Neoplasms ProstateFIPCNCT02381990
MRI/Ultrasound Fusion Guided Prostate Cryotherapy
An observational study of Neoplasms Prostate and Cancer of the Prostate, run by Urological Research Network, LLC at 1 site in United States.
Trial summary
Registration of Prostate Cancer patients undergoing Prostate Cryotherapy guided by Mutiparametric-MRI (MP-MRI) highlighting biopsy confirmed regions. The primary outcome measure is 5 year oncological control. Secondary aim is lack of progression beyond the prostate gland. Read more about this study
- Who is it for?
- Ages 55 years and older, men only
- Conditions the study is for
- Neoplasms Prostate, Cancer of the Prostate
- What is being tested?
- FUSE IMAGE MRI GUIDED PROSTATE CRYOTHERAPY
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Aug 2033
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 55 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: As written in Initial Section
Who may be able to join
- Men between 55 and 65 years of age with a clinical diagnosis of prostate cancer with Low or Intermediate risk prostate cancer, and <50% positive core rate by prostate lobe
- Men older than 65 years of age with clinical diagnosis of prostate cancer <50% positive core rate by prostate lobe
- Absence of extra-capsular extension
- Absence of seminal vesicle invasion
- Absence of regional or distant metastatic disease
- Multiparametric MRI of the prostate performed either before the biopsy or >10 weeks after prostate biopsy
- Treated with Cryotherapy of the prostate
- Treatment based on co-registration between MP-MRI and Prostate Ultrasound
Who cannot join
- Prior treatment of prostate cancer in the form of surgery.
- Performance status greater than 0 based on ECOG criteria
- Mental status impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Urological Research Network
Miami Lakes, Florida, 33016
CIELO D GUERRA, BS, 305-515-9887, CIELO@BESTUROLOGY.NET
FERNANDO J BIANCO, MD
About this study
Official title: Office Based MRI/Ultrasound Guided Prostate Cryotherapy: Outcomes Registry
Registration of Prostate Cancer patients undergoing Prostate Cryotherapy guided by Mutiparametric-MRI (MP-MRI) highlighting biopsy confirmed regions. The primary outcome measure is 5 year oncological control. Secondary aim is lack of progression beyond the prostate gland. The aim of intervention is to eradicate prostate cancer disease in the treated area while imposing no or minimal deleterious effects in quality of life.
Read the detailed description
CLINICAL TRIAL OF OBSERVATION NATURE
PRIMARY OUTCOME
Cancer control of treated areas 5, 10, 15 years after intervention based on prostate biopsy of initial treated area, progression requiring conversion to radical prostate surgery or radiation or other forms of whole gland treatment (ej, HIFU), Metastatic Free survival: CT Scan and Bone Scans, Cancer-Specific and Overall Survival
SECONDARY OUTCOMES
Secondary Interventions focal interventions due to de-novo lesions. Focal or target therapy rescue with other technologies (ej HIFU); Short, Intermediate and Long-Term Urinary and Sexual Function changes in quality of life measured by validated inventories; Anxiety related to cancer and cancer control. Treatment tolerance to local anesthesia. Patient App compliance and activity to monitor care
DATA COLLECTION
- Complete H\&P, family history, past medical and surgical history, social history, allergies, and medications
- As of July 2016, voluntary measurement thru Focalyx App for smartphones and tablets
- Imaging Specifics Assessing Prostate, Seminal Vesicles and Urethral Contouring by Multi-parametric-MRI. Dominant lesions and secondary lesions contouring my MP-MRI.
- Procedure specific Co-Registration quality with ultrasound denoting quality
- Specific ablative description and digitalization of critical measures such as: ablation type (ej cryotherapy, equipment used) procedure, cryoprobes used, freeze/thaw cycles timing, temperatures at neurovascular bundles, denonvilliers fascia. Urethral warmer requirements
- Follow up information: 30 day perioperative outcomes (incidence of UTI, urinary retention, failure of local anesthetic, pain measures). 6 week, 3,6,9,12 month and then every 6 month measures of PSA, Testosterone levels, Urinary Function and Sexual Function inventories, Overall anxiety and regret related to diagnosis and treatment
- Uroflow and PVR measurements by 3 to 6 month of treatment
- MP MRI on a yearly basis, for years 2,3,4 after treatment, biopsy driven by new suspicious MRI findings
- MP MRI triggered by elevation in PSA velocity or PSA level 10% above diagnosis
- Transperineal Fusion Guided Prostate biopsy at 1st year - emphasis on treated areas, suspicious MRI areas
- Transperineal Fusion Guided Prostate biopsy at 5th year - emphasis on treated areas, suspicious MRI areas
- 5, 10, 15 Yr CT Scans, PET Scan/Bone Scan
SAFETY MEASURES
- Periodic evaluation of registry to ensure consistency in follow up
- Patient remainders of tests required
- Conditions
- Neoplasms Prostate, Cancer of the Prostate
- Being tested
- FUSE IMAGE MRI GUIDED PROSTATE CRYOTHERAPY
- Keywords
- Prostate, PSA, FUSION, Ultrasound, MRI, Cancer, Cryotherapy, Outcomes, Recurrence, QOL, Quality of Life, Urinary function, Sexual Function
- Medical subject headings
- Prostatic Neoplasms, Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FUSE IMAGE MRI GUIDED PROSTATE CRYOTHERAPYProcedure or surgery
Also called Intervention of Interest: Prostate Cryoablation
Biopsy proven Prostate Cancer is delimited and defined by MP-MRI. The MRI study is fused with transrectal ultrasound in realtime. The cryogenic "cryoprobes/devices" are employed to freeze and all "circuled or noted" cancer lesions. Two freeze 8 min/ thaw 10 min clycles are performed. Thermocouples are used to monitor treatment areas and safety margins
What is being measured
The primary outcome is the main question the study is designed to answer.
Oncological Control
Lack of prostate cancer presence in treated area after MRI/US FUSION Biopsy
Measured: 1 Year
Secondary outcomes (5)
Oncological Control
Lack of prostate cancer presence in the gland after MRI/US FUSION Biopsy
Measured: 1 Year
Oncological Control
Lack of prostate cancer presence in gland measured by MP-MRI
Measured: Yearly, up to 10 years
Urinary Functional Outcomes
Evaluation of urinary function outcomes when compared to baseline using expanded prostate composite index and AUA symptoms scores. Urinary function also by objective measurements - uroflow and post void residuals
Measured: Every 3 months up to 24 months
Perioperative Outcomes
Procedure tolerance, need for hospital admission or ER consultation, incidence of urinary tract infection, urinary retention, any significant side effect that may occur and perioperative survivel
Measured: 30 days
Sexual Functional Outcomes
Evaluation of sexual function outcomes when compared to baseline using Sexual Inventory for men questionnaires
Measured: Every 3 months up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startAug 2013
- Primary completionAug 2023 (estimated)
- Study completionAug 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Neoplasms ProstateStudies 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
- 5,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Urological Research Network, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- FERNANDO J BIANCO, MD, Principal investigator, UROLOGICAL RESEARCH NETWORKEUSEBIO LUNA, MD, Study director, UROLOGICAL RESEARCH NETWORKIsabel H Lopez, MD, Study director, UROLOGICAL RESEARCH NETWORK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381990
- Sponsor's protocol ID
- URN-13-1010
- Acronym
- FIPC
- Status last verified
- Jan 2023
- First submitted
- 12 Jan 2015
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Non identifiable pertinent information will be shared for other scientists to evaluate other pertinent questions
Publications
Moore CM, Kasivisvanathan V, Eggener S, Emberton M, Futterer JJ, Gill IS, Grubb Iii RL, Hadaschik B, Klotz L, Margolis DJ, Marks LS, Melamed J, Oto A, Palmer SL, Pinto P, Puech P, Punwani S, Rosenkrantz AB, Schoots IG, Simon R, Taneja SS, Turkbey B, Ukimura O, van der Meulen J, Villers A, Watanabe Y; START Consortium. Standards of reporting for MRI-targeted biopsy studies (START) of the prostate: recommendations from an International Working Group. Eur Urol. 2013 Oct;64(4):544-52. doi: 10.1016/j.eururo.2013.03.030. Epub 2013 Mar 20.
PubMed 23537686Bahn D, de Castro Abreu AL, Gill IS, Hung AJ, Silverman P, Gross ME, Lieskovsky G, Ukimura O. Focal cryotherapy for clinically unilateral, low-intermediate risk prostate cancer in 73 men with a median follow-up of 3.7 years. Eur Urol. 2012 Jul;62(1):55-63. doi: 10.1016/j.eururo.2012.03.006. Epub 2012 Mar 21.
PubMed 22445223Costa DN, Pedrosa I, Donato F Jr, Roehrborn CG, Rofsky NM. MR Imaging-Transrectal US Fusion for Targeted Prostate Biopsies: Implications for Diagnosis and Clinical Management. Radiographics. 2015 May-Jun;35(3):696-708. doi: 10.1148/rg.2015140058. Epub 2015 Mar 18.
PubMed 25786055Barentsz JO, Richenberg J, Clements R, Choyke P, Verma S, Villeirs G, Rouviere O, Logager V, Futterer JJ; European Society of Urogenital Radiology. ESUR prostate MR guidelines 2012. Eur Radiol. 2012 Apr;22(4):746-57. doi: 10.1007/s00330-011-2377-y. Epub 2012 Feb 10.
PubMed 22322308Siddiqui MM, Rais-Bahrami S, Turkbey B, George AK, Rothwax J, Shakir N, Okoro C, Raskolnikov D, Parnes HL, Linehan WM, Merino MJ, Simon RM, Choyke PL, Wood BJ, Pinto PA. Comparison of MR/ultrasound fusion-guided biopsy with ultrasound-guided biopsy for the diagnosis of prostate cancer. JAMA. 2015 Jan 27;313(4):390-7. doi: 10.1001/jama.2014.17942.
PubMed 25626035
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Office Based MRI/Ultrasound Guided Prostate Cryotherapy: Outcomes Registry
- ClinicalTrials.gov ID
- NCT02381990
- Acronym / sponsor ID
- FIPC / URN-13-1010
- Conditions
- Neoplasms Prostate, Cancer of the Prostate
- Keywords
- Prostate, PSA, FUSION, Ultrasound, MRI, Cancer, Cryotherapy, Outcomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Urological Research Network, LLCUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2033 (estimated)
- First posted
- 6 Mar 2015 (estimated)
- 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.
Registration of Prostate Cancer patients undergoing Prostate Cryotherapy guided by Mutiparametric-MRI (MP-MRI) highlighting biopsy confirmed regions. The primary outcome measure is 5 year oncological control. Secondary aim is lack of progression beyond the prostate gland. The aim of intervention is to eradicate prostate cancer disease in the treated area while imposing no or minimal deleterious effects in quality of life.
Detailed description
CLINICAL TRIAL OF OBSERVATION NATURE
PRIMARY OUTCOME
Cancer control of treated areas 5, 10, 15 years after intervention based on prostate biopsy of initial treated area, progression requiring conversion to radical prostate surgery or radiation or other forms of whole gland treatment (ej, HIFU), Metastatic Free survival: CT Scan and Bone Scans, Cancer-Specific and Overall Survival
SECONDARY OUTCOMES
Secondary Interventions focal interventions due to de-novo lesions. Focal or target therapy rescue with other technologies (ej HIFU); Short, Intermediate and Long-Term Urinary and Sexual Function changes in quality of life measured by validated inventories; Anxiety related to cancer and cancer control. Treatment tolerance to local anesthesia. Patient App compliance and activity to monitor care
DATA COLLECTION
- Complete H\&P, family history, past medical and surgical history, social history, allergies, and medications
- As of July 2016, voluntary measurement thru Focalyx App for smartphones and tablets
- Imaging Specifics Assessing Prostate, Seminal Vesicles and Urethral Contouring by Multi-parametric-MRI. Dominant lesions and secondary lesions contouring my MP-MRI.
- Procedure specific Co-Registration quality with ultrasound denoting quality
- Specific ablative description and digitalization of critical measures such as: ablation type (ej cryotherapy, equipment used) procedure, cryoprobes used, freeze/thaw cycles timing, temperatures at neurovascular bundles, denonvilliers fascia. Urethral warmer requirements
- Follow up information: 30 day perioperative outcomes (incidence of UTI, urinary retention, failure of local anesthetic, pain measures). 6 week, 3,6,9,12 month and then every 6 month measures of PSA, Testosterone levels, Urinary Function and Sexual Function inventories, Overall anxiety and regret related to diagnosis and treatment
- Uroflow and PVR measurements by 3 to 6 month of treatment
- MP MRI on a yearly basis, for years 2,3,4 after treatment, biopsy driven by new suspicious MRI findings
- MP MRI triggered by elevation in PSA velocity or PSA level 10% above diagnosis
- Transperineal Fusion Guided Prostate biopsy at 1st year - emphasis on treated areas, suspicious MRI areas
- Transperineal Fusion Guided Prostate biopsy at 5th year - emphasis on treated areas, suspicious MRI areas
- 5, 10, 15 Yr CT Scans, PET Scan/Bone Scan
SAFETY MEASURES
- Periodic evaluation of registry to ensure consistency in follow up
- Patient remainders of tests required
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 55 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- As written in Initial Section
Key inclusion criteria (8 listed)
- Men between 55 and 65 years of age with a clinical diagnosis of prostate cancer with Low or Intermediate risk prostate cancer, and <50% positive core rate by prostate lobe
- Men older than 65 years of age with clinical diagnosis of prostate cancer <50% positive core rate by prostate lobe
- Absence of extra-capsular extension
- Absence of seminal vesicle invasion
- Absence of regional or distant metastatic disease
Key exclusion criteria (3 listed)
- Prior treatment of prostate cancer in the form of surgery.
- Performance status greater than 0 based on ECOG criteria
- Mental status impairment
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 |
|---|---|---|
| FUSE IMAGE MRI GUIDED PROSTATE CRYOTHERAPYAlso: Intervention of Interest: Prostate CryoablationBiopsy proven Prostate Cancer is delimited and defined by MP-MRI. The MRI study is fused with transrectal ultrasound in realtime. The cryogenic "cryoprobes/devices" are employed to freeze and all "circuled or noted" cancer lesions. Two freeze 8 min/ thaw 10 min clycles are performed. Thermocouples are used to monitor treatment areas and safety margins | Procedure or surgery | – |
Primary outcome
Oncological Control
Time frame: 1 Year
Lack of prostate cancer presence in treated area after MRI/US FUSION Biopsy
5 secondary outcomes
Oncological Control
Time frame: 1 Year
Oncological Control
Time frame: Yearly, up to 10 years
Urinary Functional Outcomes
Time frame: Every 3 months up to 24 months
Perioperative Outcomes
Time frame: 30 days
Sexual Functional Outcomes
Time frame: Every 3 months up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Results publication: PubMed 23537686Moore CM, Kasivisvanathan V, Eggener S, Emberton M, Futterer JJ, Gill IS, Grubb Iii RL, Hadaschik B, Klotz L, Margolis DJ, Marks LS, Melamed J, Oto A, Palmer SL, Pinto P, Puech P, Punwani S, Rosenkrantz AB, Schoots IG, Simon R, Taneja SS, Turkbey B, Ukimura O, van der Meulen J, Villers A, Watanabe Y; START Consortium. Standards of reporting for MRI-targeted biopsy studies (START) of the prostate: recommendations from an International Working Group. Eur Urol. 2013 Oct;64(4):544-52. doi: 10.1016/j.eururo.2013.03.030. Epub 2013 Mar 20.
- Results publication: PubMed 22445223Bahn D, de Castro Abreu AL, Gill IS, Hung AJ, Silverman P, Gross ME, Lieskovsky G, Ukimura O. Focal cryotherapy for clinically unilateral, low-intermediate risk prostate cancer in 73 men with a median follow-up of 3.7 years. Eur Urol. 2012 Jul;62(1):55-63. doi: 10.1016/j.eururo.2012.03.006. Epub 2012 Mar 21.
- Results publication: PubMed 25786055Costa DN, Pedrosa I, Donato F Jr, Roehrborn CG, Rofsky NM. MR Imaging-Transrectal US Fusion for Targeted Prostate Biopsies: Implications for Diagnosis and Clinical Management. Radiographics. 2015 May-Jun;35(3):696-708. doi: 10.1148/rg.2015140058. Epub 2015 Mar 18.
- Results publication: PubMed 22322308Barentsz JO, Richenberg J, Clements R, Choyke P, Verma S, Villeirs G, Rouviere O, Logager V, Futterer JJ; European Society of Urogenital Radiology. ESUR prostate MR guidelines 2012. Eur Radiol. 2012 Apr;22(4):746-57. doi: 10.1007/s00330-011-2377-y. Epub 2012 Feb 10.
- Results publication: PubMed 25626035Siddiqui MM, Rais-Bahrami S, Turkbey B, George AK, Rothwax J, Shakir N, Okoro C, Raskolnikov D, Parnes HL, Linehan WM, Merino MJ, Simon RM, Choyke PL, Wood BJ, Pinto PA. Comparison of MR/ultrasound fusion-guided biopsy with ultrasound-guided biopsy for the diagnosis of prostate cancer. JAMA. 2015 Jan 27;313(4):390-7. doi: 10.1001/jama.2014.17942.
- Individual participant dataSharing planned: Yes. Non identifiable pertinent information will be shared for other scientists to evaluate other pertinent questions
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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.
FERNANDO J BIANCO, MD principal investigator
UROLOGICAL RESEARCH NETWORK
EUSEBIO LUNA, MD study director
UROLOGICAL RESEARCH NETWORK
Isabel H Lopez, MD study director
UROLOGICAL RESEARCH NETWORK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms Prostate and Cancer of the Prostate, run by Urological Research Network, LLC at 1 site in United States.
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 8 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CIELO D GUERRA, BS (305-515-9887, CIELO@BESTUROLOGY.NET), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oncological Control (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02381990, which also lists 5 linked publications.
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 26 Jan 2023.