Search / Trial NCT06223295

Effectiveness of Focal Therapy in Men With Prostate Cancer

Launched by RADBOUD UNIVERSITY MEDICAL CENTER · Jan 15, 2024

Trial Information

Current as of October 04, 2024

Recruiting

Keywords

Prostate Neoplasm Focal Therapy Prostate Cancer

Description

In the Netherlands, most men with PCa are treated with radical whole-gland treatment, i.e. prostatectomy or a form of radiotherapy. The burden of complications such as incontinence and erectile dysfunction associated with radical treatment is considerable. A recent systematic review by our group has shown that focal therapy of PCa seems to reduce the burden of treatment side-effects in men with intermediate-risk disease, maintaining their quality of life without compromising oncological effectiveness. The costs of side-effects that can be prevented are estimated at €5456 per patient, resul...

Gender

MALE

Eligibility criteria

  • Inclusion Criteria:
  • * Gleason score of 7 (3 + 4 or 4 + 3; ISUP grade 2/3)
  • * PSA level of ≤ 20 ng/ml
  • * Clinical stage ≤ T2b disease
  • * Life expectancy of ≥ 10 years
  • * Men with a prostate size ≤ 5 cm in sagittal length and ≤ 6 cm in axial length
  • * Fit, eligible, and normally destined for radical surgery or radiotherapy
  • * No concomitant cancer
  • * No previous treatment of their prostate
  • * An understanding of the Dutch language sufficient to receive written and verbal information about the trial, its consent process and the study questionnaires
  • Exclusion Criteria:
  • * Unfit for general anesthesia or radical surgery
  • * Low volume low-risk disease (≤4mm Gleason score of ≤ 6 / ISUP grade 1)
  • * High-risk disease (Gleason score of ≥ 8 / ISUP grade \>3)
  • * Clinical T3 disease (extracapsular PCa)
  • * Men who have received previous active therapy for PCa.
  • * Men with evidence of extraprostatic disease.
  • * Men with an inability to tolerate a transrectal ultrasound.
  • * Cardiac pacemaker
  • * Metal implants/stents in the urethra or prostate.
  • * ASA ≥4
  • * Prostatic calcification/cysts that interfere with effective delivery of TULSA/HIFU based on MRCT.
  • * Men with renal impairment and a glomerular filtration rate (GFR) of \< 30 ml/minute/1.73 m2.
  • * Unable to give consent to participate in the trial, as judged by the attending clinicians

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Zwolle, Overijssel, Netherlands

Nieuwegein, Utrecht, Netherlands

Nijmegen, Gelderland, Netherlands

Amsterdam, Noord Holland, Netherlands

Amsterdam, , Netherlands

Etten Leur, Noord Brabant, Netherlands

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0