Status:
COMPLETED
Comparative Health Research Outcomes of NOvel Surgery in Prostate Cancer
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Prostate Cancer UK
Imperial Clinical Trials Unit (ICTU)
Conditions:
Prostate Cancer
Non-metastatic Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief 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 c...
Detailed Description
AIM: CHRONOS-A Pilot: To determine if men will agree to participate in a randomised controlled trial that randomly assigns them to focal therapy alone or radical therapy (radiotherapy or prostatecto...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04049747
Start Date
December 11 2019
End Date
March 20 2023
Last Update
March 24 2025
Active Locations (10)
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1
King's College Hospital NHS Foundation Trust
Brixton, London, United Kingdom, SE5 9RS
2
West Middlesex Hospital
Isleworth, Middlesex, United Kingdom, TW7 6AF
3
Newcastle upon Tyne Hospitals NHS Foundation Trust
High Heaton, Newcastle Upon Tyne, United Kingdom, NE7 7DN
4
Ashford & St Peter's Hospitals (ASPH) NHS Foundation Trust
Chertsey, Surrey, United Kingdom, KT16 0PZ