N/A
Completed N=100
Comparative Health Research Outcomes of NOvel Surgery in Prostate Cancer
Prostate Cancer · Non-metastatic Prostate Cancer · Prostate adenocarcinoma
Source: ClinicalTrials.gov NCT04049747 ↗
Enrolled (actual)
100
Serious AEs
8.0%
Results posted
Mar 2025
Primary outcomePrimary: Pilot: Acceptance of Randomisation to Allocated Arm Within CHRONOS A & CHRONOS B — 4; 0; 11; 10 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pilot: Acceptance of Randomisation to Allocated Arm Within CHRONOS A & CHRONOS B |
4; 0; 11; 10; 11; 11 | — |
| PRIMARY Pilot: Recruitment Rate to CHRONOS A & CHRONOS B and Their Corresponding 95% Confidence Intervals |
8.5; 8.5; 14.9; 14.2; 14.2 | — |
| PRIMARY Pilot: Treatment Compliance to CHRONOS - A |
72.2; 88.9 | — |
| PRIMARY Pilot: Treatment Compliance (CHRONOS-B) |
100; 100; 100 | — |
| PRIMARY Drug Compliance to CHRONOS-B Only |
33.3; 23.8; 100; 100 | — |
| PRIMARY Pilot: Randomisation Rate to CHRONOS A & CHRONOS B and Their Corresponding 95% Confidence Intervals |
48.6; 48.6; 34.4; 32.8; 32.8 | — |
Eligibility Criteria
Inclusion Criteria
- PSA /=6mm cancer core length in any one core. Patients with Gleason 4+4=8 in some cores but where the overall Gleason score is 7 will be included.
- Bilateral histologically proven prostate cancer is permissible provided the following criteria are met:
- The index lesion to be treated if focal therapy is used meets the above histological criteria.
- The patient may have a PIRADS or Likert score 3, 4, 5 mpMRI lesion on the same hemi-gland (either right/left or anterior/posterior) as the histological index lesion
- Secondary areas of Gleason 3+3=6 of /=50% of one lobe will require central review prior to enrolment. Final decisions on suitability of focal therapy will lie with the trial central review in these cases.
- No restriction exists in CHRONOS-A on previous or current use of 5-alpha reductase inhibitors or anti-androgens or LHRH agonists or LHRH antagonists.
- Age at least 18 years of age
- Participants must be fit to undergo all procedures listed in the protocol as judged by clinical team
Exclusion Criteria
- Previous or current LHRH agonist or LHRH antagonist or anti-androgen use in CHRONOS-B.
- Patients already established on a 5 alpha-reductase inhibitor (finasteride or dutasteride) who wish to go into CHRONOS-B will need to discontinue this for at least 6 months prior to randomisation. (NB: testosterone supplementation is permitted)
- Previous treatment for prostate cancer
- Life expectancy is likely to be less than 10 years
- Unable to give informed consent
Data sourced from ClinicalTrials.gov (NCT04049747). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.