Clinical trial · Interventional
Comparative Health Research Outcomes of NOvel Surgery in Prostate Cancer
Imperial Prostate 4: Comparative Health Research Outcomes of NOvel Surgery in Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-metastatic Prostate Cancer | — | UNRESOLVED | — |
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Focal therapy | Procedure | — | UNRESOLVED |
| Focal therapy after Bicalutamide 50Mg tablets for 12 weeks | Procedure | — | UNRESOLVED |
| Focal therapy after Finasteride 5Mg tablets for 12 weeks | Procedure | — | UNRESOLVED |
| Radical therapy (radiotherapy or prostatectomy [radiotherapy can be external beam or brachytherapy] | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- CHRONOS A - Arm 1 (Control)
- description
- Radical therapy (radiotherapy or prostatectomy \[radiotherapy can be external beam or brachytherapy\]). In patients undergoing radiotherapy a maximum of 6-months neo-adjuvant hormonal therapy will be allowed. In patients undergoing radical prostatectomy, cytoreduction of maximum 6 months with medication will be permissible, provided this is part of local practice.
- interventionNames
- Procedure: Radical therapy (radiotherapy or prostatectomy [radiotherapy can be external beam or brachytherapy]
- type
- EXPERIMENTAL
- label
- CHRONOS A - Arm 2 (Intervention)
- description
- Focal therapy alone (high intensity focused ultrasound \[HIFU\] or cryotherapy as per physician and centre choice). A second focal therapy session in-field, or a first focal therapy session to an out-of-field progressive or de novo lesion will be allowed as part of the focal therapy intervention.
- interventionNames
- Procedure: Focal therapy
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 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
References
Publications (1)
- DERIVEDReddy D, Shah TT, Dudderidge T, McCracken S, Arya M, Dobbs C, Emberton M, Fiorentino F, Day E, Prevost AT, Staffurth J, Sydes M, Winkler M, Ahmed HU. Comparative Healthcare Research Outcomes of Novel Surgery in prostate cancer (IP4-CHRONOS): A prospective, multi-centre therapeutic phase II parallel Randomised Control Trial. Contemp Clin Trials. 2020 Jun;93:105999. doi: 10.1016/j.cct.2020.105999. Epub 2020 Apr 14. PMID 32302790