Men with a new diagnosis of low- and intermediate-risk prostate cancer Cancer Malignant neoplasm of prostate
Conditions
Interventions
Current interventions as of 24/06/2025:
For men randomised within 6 months of their diagnosis date, it is likely their standard active surveillance assessments will align with their FINESSE Trial foll
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
Male
Age
50 Years to 75 Years
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 24/06/2024: 1. Male participants: 1.1. Aged 50 to 75 years 1.2. With an estimated life expectancy of 10 years or more 1.3. Those who have opted for Active Surveillance as their preferred prostate cancer therapy. 2. Willing and able to provide written informed consent or, if appropriate, have an acceptable individual capable of giving consent on their behalf 3. Fit enough and suitable for radical treatment 4. Eastern Oncology Performance (ECOG) status = 1 5. Histopathological diagnosis of low or intermediate risk adenocarcinoma of the prostate in the last 24 months (from the date of histology to the date of the patient’s randomisation) 6. Gleason grade group = 2 (i.e. Gleason grade = 3+4=7) 7. Radiological stage =T2c cN0 cM0 as defined by MRI imaging within the last 12 months (from the date of the MRI scan to the date of the patient’s randomisation). A copy of the MRI scan and report confirming eligibility will be required. In this study, MX will be treated as M0, and NX will be treated as N0. 8. PSA =20ng/ml. The result must be within 3 months of the date of the patient’s randomisation 9. PSA Density =0.2 ng/ml. NB: For the PSA density result to be valid, the PSA test from which the serum PSA level value is taken must be dated within the last three months, and the MRI scan from which the prostate volume is taken must be dated within the last 12 months 10. Biopsy criteria (route can be trans-rectal or trans-perineal, but must have been within the last 24 months of the patient’s randomisation date) Previous participant inclusion criteria as of 12/12/2023 to 24/06/2025: 1. Male participants: 1.1. Aged 50 to 75 years old 1.2. With an estimated life expectancy of 10 years or more 1.3. Have opted for Active Surveillance as their preferred prostate cancer therapy 2. Willing and able to provide written informed consent or if appropriate, have an acceptable individual capable of giving consent on their behalf 3. Fit enough and suitable for radical treatment 4. Eastern Oncology Performance (ECOG) status = 1 (See figure one below) 5. Histopathological diagnosis of low or intermediate-risk adenocarcinoma of the prostate in the last 24 months (from the date of histology to the date of the patient’s randomisation) 6. Gleason grade group = 2 (i.e. Gleason grade = 3+4=7) 7. Radiological stage =T2c cN0 cM0 as defined by bpMRI/mpMRI imaging within the last 12 months (from the date of the bpMRI/mpMRI scan to the date of the patient’s randomisation). A copy of the bpMRI/mpMRI scan, and report confirming eligibility will be required. In this study, MX will be treated as M0, and NX will be treated as N0. 8. PSA =20ng/ml. The result must be within 3 months of the date of the patient’s randomisation. 9. PSA Density =0.2 ng/ml. The result must be within 3 months of the date of the patient’s randomisation 10. Biopsy criteria (route can be trans-rectal or trans-perineal, but must have been within the last 24 months of the patient’s randomisation date) regardless of biopsy strategy: 10.1. Maximum cancer core length is = 10mm 10.2. =3cores involved with cancer Previous participant inclusion criteria as of 16/11/2021 to 12/12/2023: 1. Male subjects aged 50 to 75 years with an estimated life expectancy of 10 years or more, who have opted for Active Surveillance as their preferred prostate cancer therapy 2. Willing and able to provide written informed consent or if appropriate, have an acceptable individual cap
Exclusion criteria
Exclusion criteria: 1. Those not fit for radical treatment 2. Those who have previously received treatment for prostate cancer (including radiotherapy, hormone therapy, brachytherapy or surgery) 3. Whose life expectancy is < 10 years 4. Either current or recent (=12 months) treatment with finasteride or dutasteride 5. Currently enrolled or has been a participant within the last 30 days, in any other investigational drug or device study 6. Men not willing to comply with the procedural requirements of this protocol 7. Known allergy/sensitivity to, or intolerance of, finasteride or other 5-alpha reductase inhibitors, e.g., dutasteride. Known allergy to any excipients of finasteride 8. Any malignancy (other than non-melanoma skin cancer) that has not been in complete remission for five years 9. Any serious co-existent medical condition that would make repeat prostate biopsy hazardous 10. All contraindications to finasteride including concomitant therapy with any medication that may interact with finasteride 11. Any rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption 12. Men trying for a baby or with a pregnant partner
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 24/06/2025: Adherence to active surveillance in men with low or intermediate prostate cancer with and without 2 years of finasteride during follow-up of between 2 and 5 years from randomisation. Adherence is defined as men who have received neither radical nor palliative treatment, and have remained progression-free under surveillance, at each time point. Previous primary outcome measure: Adherence with Active Surveillance at 2 and 5 years after diagnosis. Adherence is defined as the absence of a change in treatment to radical therapy or treatment of advanced disease, measured using patient records. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 24/06/2025: 1. Time until cessation of AS due to: 1.1. ADT and/or chemotherapy initiation 1.2. Radical Prostatectomy 1.3. Radical Radiotherapy initiation 1.4. Other treatment, including watchful waiting 1.5. Death from prostate cancer 2. Participant's death from prostate cancer 3. Changes in MRI appearances of the prostate over time in men with/without finasteride measured using MRI scan results at baseline, 12 and 36 months study follow-up timepoints 4. Views of patients and healthcare professionals regarding the use of finasteride within active surveillance for this disease were measured using semi-structured one-to-one interviews led by a trained interviewer, with selected individuals during the follow-up phase (months 36 to 48 inclusive). 5. The rate of intervention for symptoms related to benign prostate enlargement (defined as the use of oral medication (such as alpha blocker, PDE5 inhibitor or anti-cholinergic) or endoscopic prostate surgery (such as TURP, Urolift, Green light laser TURP, steam treatment, HOLEP or other)), measured using patient self-reporting 6. Overall (all-cause) mortality measured using data collected on death in the electronic case report forms (eCRF) completed by sites Previous secondary outcome measures: 1. Quality of life measured using EQ-5D-5L, EORTC QLQ C30, EPIC, EORTC QLQ FA12, Memorial Anxiety Scale PC, DASS 21, completed at 3, 6, 12, 18, 24, 36, 48 and 60 months 2. Compliance with and tolerability of finasteride measured in the Finasteride arm by summary of tablets returned count (median and minimum, maximum) at the end of treatment 3. Satisfaction and quality of decision-making measured using Decisional Conflict Scale, Subjective decision quality scale, Decisional regret scale at 3, 6, 12, 18, 24, 36, 48 and 60 4. Side effects of finasteride measured using the count of adverse events in Finasteride arm. All adverse events occurring during the 3-5 year follow-up of the study 5. Pr | — |
Countries
England, United Kingdom
Contacts
Public ContactJim;Roseann Catto;Kealy
;
Outcome results
None listed