Prostate cancer MedDRA version: 20.0 Level: LLT Classification code 10001186 Term: Adenocarcinoma of prostate System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Finasteride
Product Name: Finasteride
Pharmaceutical Form: Tablet
INN or Proposed INN: finasteride
Concentration unit: mg milligram(s)
Concentration type: equal
Trade Name: Bicalutamide
P
Sponsors
Imperial Joint Research Compliance Office
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Prostate cancer confirmed on biopsy of Gleason 6 or Gleason 7 overall 2) Serum PSA (prostate specific antigen) less than or equal to 20ng/ml 3) Stage =65 years) yes F.1.3.1 Number of subjects for this age range 450
Exclusion criteria
Exclusion criteria: 1) Previous prostate cancer treatment 2) Life expectancy less than 10 years 3) Unable to consent to participation in the trial 4) Previous or current use of current LHRH agonist or LHRH antagonist or anti-androgen use in CHRONOS-B 5) Less than 6 months of discontinuation of 5 alpha-reductase inhibitor use in CHRONOS-B
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Our initial CHRONOS trial will be a pilot study. If successful, we will apply for funding for a full main study which will run through if and when funding is approved. We have therefore described the objectives for both phases of CHRONOS, and for both CHRONOS-A and CHRONOS-B. Pilot study: 1)To determine patient acceptance to randomisaton 2) To coniduct an embedded qualitative study of patient and clinician acceptance and experience of the linked RCT CHRONOS design 3) To establish the feasibility of an economic evaluation alongside the main trial 4) To determine the acceptability and completeness of resource use and utility measures (EQ- 5D- 5L) 5) To identify the relevant NHS and non-NHS resource use to be collected alongside the main trial 6) To identify the relevant items to populate the Cost and Consequences framework 7) To perform preliminary analysis of pattern of missing data Main study: CHRONOS A: To evaluate cancer control rates of focal therapy compared to standard of care ;Secondary Objective: Disease Control To determine the histological, biochemical and oncological disease control for men undergoing radical therapy, focal therapy with neo/adjuvant treatments Adverse events and functional outcomes To determine the adverse events and functional outcomes after radical therapy, focal therapy or focal therapy with neo/adjuvant treatments Health Economics To establish the NHS costs of the different interventions To determine the Cost per QALYs (CUA), cost per PFS/FFS (CEA) and cost and consequences (CCA) To determine acceptability and completeness of resource use and utility measures (EQ-5D-5L) Qualitative Analyse the patient experience of consent and recruitment, including reasons for declining participation. To analyse participants' motivation to accept randomisation to and compliance with an intervention, which may or may not include neoadjuvant and adjuvant treatments. To review patients' understanding and experience of each trial arm | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Determine the adverse events associated with radical therapy, focal therapy and focal therapy with neo/adjuvant treatments. 2) Determine the cost per QALY, cost per progression/ failure free survival and cost and consequences 3) To estimate the incremental cost per quality adjusted life year (QALYs) gained over the estimated lifetime of participants for focal therapy compared to radical therapy 4) To estimate the incremental cost per quality adjusted life year (QALYs) gained over the estimated lifetime of participants for focal therapy compared to focal therapy with a neoadjuvant and/or adjuvant strategies 5) Patient experience of consent and recruitment, including reasons for declining participation 6) Participants' motivation to accept randomisation to and compliance with an intervention, which may or may not include neoadjuvant and adjuvant treatments. 7) Patients' understanding and experience of each trial arm 8) Patients' experience of toxicities focusing on erectile dysfunction and urinary symptoms 9) Patients' attitudes to the predicted survival rate 10) Potential improvements to recruitment processes 11) To evaluate cancer infiltrating immune cells and immune gene signatures following ablation;Timepoint(s) of evaluation of this end point: Toxicities will be evaluated throughout the follow-up period. Progression/ failure free survival will be evaluated throughout the 5 year follow up period, and specific analysis wlil be determined at 1 year in patients undergoing focal therapy. Determination for reasons to decline enrolment into the study will be as close to declining visit as possible. All other end points will be evaluated over the 5 year follow-up period. | — |
Countries
United Kingdom
Contacts
Public ContactProfessor Hashim Ahmed
Imperial College London
Outcome results
None listed