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- Treatment
- Interventional
- Randomized
- Procedure
- Imperial College London
- 18 Years -
Study Purpose
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.
Intervention
Procedure : Radical therapy (radiotherapy or prostatectomy [radiotherapy can be external beam or brachytherapy]
Procedure : Focal therapy
Procedure : Focal therapy after Finasteride 5Mg tablets for 12 weeks
Procedure : Focal therapy after Bicalutamide 50Mg tablets for 12 weeks
Eligibility Requirements
PSA \</=20ng/ml
Patients must have undergone a diagnostic pre-biopsy MRI compliant with national uro-radiology consensus guidelines. Dynamic contrast enhancement using gadolinium is not required at diagnostic stage. However, contrast enhancement MRI will be required in those men who undergo focal therapy prior to focal therapy as a baseline for comparison during follow-up. In the absence of a compliant MRI (for clinical or other reasons), a transperineal template mapping biopsy using a 5-10 mm sampling frame will be required
Histologically proven prostate adenocarcinoma
Overall Gleason score of 7 (either 3+4=7 or 4+3=7) of any length or Gleason 3+3=6 provided \>/=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 \</=5mm cancer outside of the treatment field can be monitored, if present, and patient undergoes focal therapy.
* If a Likert or PIRADS score 3,4 or 5 mpMRI lesion is present in an area outside of the treatment field with a negative biopsy for cancer then pathology must be reviewed and confirm the presence of inflammation or atrophy if the patient is to undergo focal therapy\*
Radiological stage T2b/T3a will require central review regarding suitability for focal therapy.
Index tumour volume, as seen on mpMRI if carried out, will be restricted to 50% of one lobe for either unilateral or bilateral ablation, patients with tumour volume \>/=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
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
Recruiting status
Recruiting
Estimated enrollment
2450
Study start date
Dec 11, 2019
Study end date
May 31, 2027
Last updated
Mar 23, 2025
Primary purpose
Treatment
Design
Interventional
Intervention
Procedure
Study phase
NA
Allocation
Randomized
Sponsor:
Imperial College London
Collaborator:
Prostate Cancer UK
Imperial Clinical Trials Unit (ICTU)
Investigator:
Hashim Ahmed
N/A
NCT04049747
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