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Comparative Health Research Outcomes of NOvel Surgery in Prostate Cancer

NCT04049747 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-03-24

Study results available
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Summary

Men diagnosed with significant cancer confined to the prostate currently undergo radical therapy directed to the whole prostate (radiotherapy or prostatectomy). These provide good cancer control but can cause significant side effects.

Focal Therapy involves targeting the cancer alone, whilst leaving healthy prostate gland alone. Case series have shown similar cancer control over 5 years with a much better side effect profile. However, there have been no randomised control trials (RCTs) comparing the success in cancer control and the quality of life in patients that undergo radical therapy vs those that undergo focal therapy. Further, there is a need to assess the use of additional therapies that may improve the cancer control outcomes following focal therapy. By having a trials platform with two RCTs (CHRONOS-A and CHRONOS-B) that reflect best patient and physician preferences/ equipoise, the investigators aim to answer these questions.

To improve acceptability, recruitment and compliance, the investigators have an embedded study aimed at reviewing clinician and patient perspectives and trial acceptability. CHRONOS-A will compare radical therapy to focal therapy, whilst CHRONOS-B will compare focal therapy alone to focal therapy with various therapies targeting the testosterone pathway that can shrink the cancer before it is treated. The investigators think this might improve outcomes further for men that definitely want focal therapy.

Conditions

Interventions

PROCEDURE

Radical therapy (radiotherapy or prostatectomy [radiotherapy can be external beam or brachytherapy]

Radical therapy (radiotherapy or prostatectomy \[radiotherapy can be external beam or brachytherapy\]

PROCEDURE

Focal therapy

Focal therapy (high intensity focused ultrasound or cryotherapy)

PROCEDURE

Focal therapy after Finasteride 5Mg tablets for 12 weeks

finasteride 5mg tablets 12 weeks prior to focal therapy

PROCEDURE

Focal therapy after Bicalutamide 50Mg tablets for 12 weeks

Bicalutamide 50mg per day - 12 weeks prior to focal therapy

Sponsors & Collaborators

  • Prostate Cancer UK

    collaborator OTHER

  • Imperial Clinical Trials Unit (ICTU)

    collaborator UNKNOWN

  • Imperial College London

    lead OTHER

Principal Investigators

  • Hashim Ahmed · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-11
Primary Completion
2023-03-20
Completion
2023-03-20

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04049747 on ClinicalTrials.gov