Fuse Image MRI Guided Prostate Cryotherapy

  • STATUS
    Recruiting
  • End date
    Jun 21, 2023
  • participants needed
    5000
  • sponsor
    Urological Research Network, LLC
Updated on 10 October 2021
cryotherapy
metastasis
biopsy of prostate
multiparametric magnetic resonance imaging

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 years after intervention based on prostate biopsy of initial treated area

SECONDARY OUTCOMES

Lack of cancer presence or progression 5 years after initial intervention by MP-MRI imaging; urinary and sexual function changes in quality of life; anxiety related to cancer and cancer control, number of biopsies required during study period; need of further treatment for prostate cancer; treatment tolerance to local anesthesia

DATA COLLECTION

  • Complete H&P, family history, past medical and surgical history, social history, allergies, and medications
  • Procedure Specifics Assessing Prostate, Seminal Vesicles and Urethral Contouring by MP-MRI. Dominant lesions and secondary lesions contouring my MP-MRI. Co-Registration quality, date of 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

SAFETY MEASURES

  • Periodic evaluation of registry to ensure consistency in follow up
  • Patient remainders of tests required

Details
Condition Malignant neoplasm of prostate, Prostate Cancer, Prostate Cancer, Early, Recurrent, Prostatic disorder, Prostate Disorders, Prostate Disorders, Prostate Cancer, Early, Recurrent, Prostate Cancer, prostate carcinoma, prostate cancers
Treatment FUSE IMAGE MRI GUIDED PROSTATE CRYOTHERAPY
Clinical Study IdentifierNCT02381990
SponsorUrological Research Network, LLC
Last Modified on10 October 2021

Eligibility

Yes No Not Sure

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
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