MRI/Ultrasound Fusion Guided Prostate Cryotherapy

NCT02381990 | Recruiting DMC

• 1 other identifier: URN-13-1010
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms Prostate; Cancer of the Prostate

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Oncological Control

  Lack of prostate cancer presence in treated area after MRI/US FUSION Biopsy

  1 Year

Secondary Outcomes (5)

• Oncological Control

  1 Year

• Oncological Control

  Yearly, up to 10 years

• Urinary Functional Outcomes

  Every 3 months up to 24 months

• Perioperative Outcomes

  30 days

• Sexual Functional Outcomes

  Every 3 months up to 24 months

Other Outcomes (1)

• Secondary Treatment Requirement

  Yearly, up to 10 years

Interventions

FUSE IMAGE MRI GUIDED PROSTATE CRYOTHERAPY PROCEDURE

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

Also known as: Intervention of Interest: Prostate Cryoablation

Eligibility Criteria

• Age: 55 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

As written in Initial Section

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Urological Research Network, LLC: lead

Study Sites (1)

Urological Research Network

Miami Lakes, Florida, 33016, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 23537686 RESULT

• 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.

  PMID: 22445223 RESULT

• 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.

  PMID: 25786055 RESULT

• 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.

  PMID: 22322308 RESULT

• 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.

  PMID: 25626035 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• FERNANDO J BIANCO, MD

  UROLOGICAL RESEARCH NETWORK

  PRINCIPAL INVESTIGATOR

• EUSEBIO LUNA, MD

  UROLOGICAL RESEARCH NETWORK

  STUDY DIRECTOR

• Isabel H Lopez, MD

  UROLOGICAL RESEARCH NETWORK

  STUDY DIRECTOR

Central Study Contacts

CIELO D GUERRA, BS

CONTACT

305-515-9887; CIELO@BESTUROLOGY.NET

LUANDA SIANO, PA

CONTACT

305-822-7227; LUANDA@BESTUROLOGY.NET

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2015
• First Posted: March 6, 2015
• Study Start: August 1, 2013
• Primary Completion: August 1, 2023
• Study Completion (Estimated): August 1, 2033
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)