MRI/Ultrasound Fusion Guided Prostate Cryotherapy (FIPC)

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ClinicalTrials.gov Identifier: NCT02381990

Recruitment Status : Recruiting

First Posted : March 6, 2015

Last Update Posted : January 26, 2023

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Sponsor:

Information provided by (Responsible Party):

Urological Research Network, LLC

Study Description

Brief 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. 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.

Condition or disease	Intervention/treatment
Neoplasms Prostate Cancer of the Prostate	Procedure: FUSE IMAGE MRI GUIDED PROSTATE CRYOTHERAPY

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

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Study Type :	Observational [Patient Registry]
Estimated Enrollment :	5000 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Target Follow-Up Duration:	10 Years
Official Title:	Office Based MRI/Ultrasound Guided Prostate Cryotherapy: Outcomes Registry
Actual Study Start Date :	August 2013
Estimated Primary Completion Date :	August 2023
Estimated Study Completion Date :	August 2033

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Prostate cancer

MedlinePlus related topics: Prostate Cancer

U.S. FDA Resources

Groups and Cohorts

Intervention Details:

Procedure: FUSE IMAGE MRI GUIDED PROSTATE CRYOTHERAPY
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

Other Name: Intervention of Interest: Prostate Cryoablation

Outcome Measures

Primary Outcome Measures :

Oncological Control [ Time Frame: 1 Year ]
Lack of prostate cancer presence in treated area after MRI/US FUSION Biopsy

Secondary Outcome Measures :

Oncological Control [ Time Frame: 1 Year ]
Lack of prostate cancer presence in the gland after MRI/US FUSION Biopsy
Oncological Control [ Time Frame: Yearly, up to 10 years ]
Lack of prostate cancer presence in gland measured by MP-MRI
Urinary Functional Outcomes [ Time Frame: Every 3 months up to 24 months ]
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
Perioperative Outcomes [ Time Frame: 30 days ]
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
Sexual Functional Outcomes [ Time Frame: Every 3 months up to 24 months ]
Evaluation of sexual function outcomes when compared to baseline using Sexual Inventory for men questionnaires

Other Outcome Measures:

Secondary Treatment Requirement [ Time Frame: Yearly, up to 10 years ]
Type of treatments required after initial intervention over time

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	55 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

As written in Initial Section

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Prior treatment of prostate cancer in the form of surgery.
Performance status greater than 0 based on ECOG criteria
Mental status impairment

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02381990

Contacts

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Contact: CIELO D GUERRA, BS	305-515-9887	CIELO@BESTUROLOGY.NET
Contact: LUANDA SIANO, PA	305-822-7227	LUANDA@BESTUROLOGY.NET

Locations

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United States, Florida
Urological Research Network	Recruiting
Miami Lakes, Florida, United States, 33016
Contact: CIELO D GUERRA, BS 305-515-9887 CIELO@BESTUROLOGY.NET
Principal Investigator: FERNANDO J BIANCO, MD
Sub-Investigator: EDWARD L GHEILER, MD
Sub-Investigator: ARIEL M KAUFMAN, MD
Sub-Investigator: EUSEBIO J LUNA, MD

Sponsors and Collaborators

Urological Research Network, LLC

Investigators

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Principal Investigator:	FERNANDO J BIANCO, MD	UROLOGICAL RESEARCH NETWORK
Study Director:	EUSEBIO LUNA, MD	UROLOGICAL RESEARCH NETWORK
Study Director:	Isabel H Lopez, MD	UROLOGICAL RESEARCH NETWORK

More Information

Additional Information:

Publications of Results:

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.

Bahn 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.

Costa 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.

Barentsz 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.

Siddiqui 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.

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Responsible Party:	Urological Research Network, LLC
ClinicalTrials.gov Identifier:	NCT02381990
Other Study ID Numbers:	URN-13-1010
First Posted:	March 6, 2015 Key Record Dates
Last Update Posted:	January 26, 2023
Last Verified:	January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	Non identifiable pertinent information will be shared for other scientists to evaluate other pertinent questions

Keywords provided by Urological Research Network, LLC:


Prostate PSA FUSION Ultrasound MRI Cancer	Cryotherapy Outcomes Recurrence QOL, Quality of Life Urinary function Sexual Function

Additional relevant MeSH terms:

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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms	Genital Diseases, Male Genital Diseases Urogenital Diseases Prostatic Diseases Male Urogenital Diseases

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