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Intervention Trial Evaluating Focal Therapy Using High Intensity Focused Ultrasound for the Treatment of Prostate Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE2/PHASE3

Intervention Trial Evaluating Focal Therapy Using High Intensity Focused Ultrasound for the Treatment of Prostate Cancer

NCT02265159•University of Zurich

View on ClinicalTrials.gov

Summary

The investigators aim to evaluate cancer control, genitourinary, rectal and overall health-related quality of life outcomes and effectiveness of focal therapy for localised prostate cancer using High Intensity Focused Ultrasound (HIFU).

Eligibility

Age

40 - 99 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Histologically proven prostate cancer on trans-rectal or transperineal template prostate biopsies
•Template biopsy:
•* unilateral disease (Gleason ≤4+3)
•* bilateral disease: presence of clinically significant cancer in both sides (Gleason ≤4+3) OR clinically insignificant disease with a burden of \>50% of biopsy cores taken on that side, OR bilateral clinically insignificant disease and \<50% of biopsy cores positive on any one side but with dominant disease burden on one side
•Stage T1-T2cN0M0 disease, as determined by local guidelines (radiological T3a permitted)
•Serum PSA ≤15
•Life expectancy of ≥10 years
•Signed informed consent by patient
•An understanding of the German language sufficient to understand written and verbal information about the trial and consent process

Exclusion Criteria

•Men who have had androgen suppression/hormone treatment within the previous 12 months for their prostate cancer
•Men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging
•Men with an inability to tolerate a transrectal ultrasound
•Men with latex allergies as the HIFU probe is covered with a latex condom sheath prior to insertion into the back passage
•Men who have undergone prior significant rectal surgery preventing insertion of trans-rectal HIFU probe (decided on the type of surgery in individual cases)
•Men who have had previous HIFU, cryosurgery, thermal or microwave therapy to the prostate.
•Men who have undergone a Transurethral Resection of the Prostate (TURP) for symptomatic lower urinary tract symptoms within 6 months. These patients may be included within the trial if deferred from consenting and screening until at least 6 months following the TURP.
•Men not fit for major surgery as assessed by a Consultant Anaesthetist
•Men unable to have pelvic MRI scanning (severe claustrophobia, permanent cardiac pacemaker, metallic implant etc likely to contribute significant artefact to images)
•Presence of metal implants/stents in the urethra
+2 more criteria

Locations (1)

Klinik für Urologie, Universitätsspital Zürich

Zurich, Canton of Zurich, Switzerland

Key Dates

Start Date

May 1, 2014

Primary Completion Date

May 1, 2020

Completion Date

May 1, 2020

Last Updated

October 27, 2016

Enrollment

100

ESTIMATED participants

Conditions

Prostate Cancer

Interventions

Focal Therapy Using High Intensity Focused Ultrasound

PROCEDURE

Contacts

Daniel Eberli, PD Dr. PhD

CONTACT

+41 44 255 95 49 Daniel.Eberli@usz.ch

Ashkan Mortezavi, Dr.

CONTACT

+41 44 255 11 11 Ashkan.Mortezavi@usz.ch

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06842498

Metastatic Castration-Resistant Prostate Cancer

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RECRUITINGPHASE2

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

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Metastatic Prostate Adenocarcinoma With Neuroendocrine DifferentiationMetastatic Prostate Neuroendocrine Carcinoma+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 27, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Intervention Trial Evaluating Focal Therapy Using High Intensity Focused Ultrasound for the Treatment of Prostate Cancer

Inclusion Criteria

Exclusion Criteria

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

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PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC