MRI/Ultrasound Fusion Guided Prostate Cryotherapy

Cancer of the Prostate Clinical Trial

— FIPC  

Official title:

Office Based MRI/Ultrasound Guided Prostate Cryotherapy: Outcomes Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02381990
• Other study ID #: URN-13-1010
• Status: Recruiting
• Start date: August 2013
• Est. completion date: August 2033

Study information

• Verified date: January 2023
• Source: Urological Research Network, LLC
• Contact: CIELO D GUERRA, BS
• Phone: 305-515-9887
• Email: CIELO[@]BESTUROLOGY.NET
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: August 2033
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of the Prostate
• Neoplasms Prostate
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Urological Research Network	Miami Lakes	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Urological Research Network, LLC

Country where clinical trial is conducted

United States, 

References & Publications (5)

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 — View Citation

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 2 — View Citation

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 201 — View Citation

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, Ukimu — View Citation

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 th — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Secondary Treatment Requirement	Type of treatments required after initial intervention over time	Yearly, up to 10 years
Primary	Oncological Control	Lack of prostate cancer presence in treated area after MRI/US FUSION Biopsy	1 Year
Secondary	Oncological Control	Lack of prostate cancer presence in the gland after MRI/US FUSION Biopsy	1 Year
Secondary	Oncological Control	Lack of prostate cancer presence in gland measured by MP-MRI	Yearly, up to 10 years
Secondary	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	Every 3 months up to 24 months
Secondary	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	30 days
Secondary	Sexual Functional Outcomes	Evaluation of sexual function outcomes when compared to baseline using Sexual Inventory for men questionnaires	Every 3 months up to 24 months