Trial Outcomes & Findings for Comparative Health Research Outcomes of NOvel Surgery in Prostate Cancer (NCT NCT04049747)
NCT ID: NCT04049747
Last Updated: 2025-03-24
Results Overview
To assess the acceptance of randomisation to the allocated arm within CHRONOS A \& CHRONOS B separately using rates of compliance, and rates of withdrawal
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
12 months
Results posted on
2025-03-24
Participant Flow
CHRONOS-A: At a conservative rate the two-arm RCT was expected to recruit 60 patients in the Pilot Stage in 6 centres over 12-months. CHRONOS-B: The three-arm MAMS RCT was expected to recruit 60 patients in the Pilot Stage in 6 centres over 12-months
CHRONOS A Arms have been combined as the Study aim was to determine if patients would agree to partake in an RCT that randomly assigns them to focal therapy alone or radical therapy CHRONOS B Arms have been combined as the Study aim was to determine if patients would agree to partake in an RCT that randomly assigns them to focal therapy alone or focal therapy in combination with neoadjuvant
Participant milestones
| Measure |
CHRONOS A - Arm 1 (Control)
CHRONOS-A was a two arm RCT.
• Arm 1 (Control): 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 was allowed. In patients undergoing radical prostatectomy, cytoreduction a maximum of 6 months with medication was permissible, provided this was part of local practice.
|
CHRONOS A - Arm 2 (Intervention)
CHRONOS-B was a Multi-Arm Multi-Stage (MAMS) RCT.
• Arm 2 (Intervention): Neoadjuvant finasteride 5mg once daily for a minimum of 12 weeks followed by focal therapy (as per control arm).
|
CHRONOS B - Arm 3 (Control)
Focal therapy alone (high intensity focused ultrasound \[HIFU\] or cryotherapy as per physician and centre choice). A second treatment in-field, or a first focal ablation to an out-of-field progressive or de novo lesion will be allowed but will be regarded as failure events for the purpose of CHRONOS-B.
Radical therapy (radiotherapy or prostatectomy \[radiotherapy can be external beam or brachytherapy\]: Radical therapy (radiotherapy or prostatectomy \[radiotherapy can be external beam or brachytherapy\]
|
CHRONOS B - Arm 4 (Intervention)
Neoadjuvant finasteride 5mg once daily for a minimum of 12 weeks followed by focal therapy (as per CHRONOS B control arm).
Focal therapy after Finasteride 5Mg tablets for 12 weeks: finasteride 5mg tablets 12 weeks prior to focal therapy
|
CHRONOS B - Arm 5 (Intervention)
Neoadjuvant bicalutamide 50mg once daily therapy for a minimum of 12 weeks followed by focal therapy (as per control arm).
Focal therapy after Bicalutamide 50Mg tablets for 12 weeks: Bicalutamide 50mg per day - 12 weeks prior to focal therapy
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
22
|
21
|
21
|
|
Overall Study
COMPLETED
|
15
|
17
|
22
|
21
|
21
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Only CHRONOS A used 5ARI. This was an exclusion criteria for B
Baseline characteristics by cohort
| Measure |
CHRONOS A - Arm 1 (Control)
n=18 Participants
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.
Radical therapy (radiotherapy or prostatectomy \[radiotherapy can be external beam or brachytherapy\]: Radical therapy (radiotherapy or prostatectomy \[radiotherapy can be external beam or brachytherapy\]
|
CHRONOS A - Arm 2 (Intervention)
n=18 Participants
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.
Focal therapy: Focal therapy (high intensity focused ultrasound or cryotherapy)
|
CHRONOS B - Arm 3 (Control)
n=22 Participants
Focal therapy alone (high intensity focused ultrasound \[HIFU\] or cryotherapy as per physician and centre choice). A second treatment in-field, or a first focal ablation to an out-of-field progressive or de novo lesion will be allowed but will be regarded as failure events for the purpose of CHRONOS-B.
Radical therapy (radiotherapy or prostatectomy \[radiotherapy can be external beam or brachytherapy\]: Radical therapy (radiotherapy or prostatectomy \[radiotherapy can be external beam or brachytherapy\]
|
CHRONOS B - Arm 4 (Intervention):
n=21 Participants
Neoadjuvant finasteride 5mg once daily for a minimum of 12 weeks followed by focal therapy (as per CHRONOS B control arm).
Focal therapy after Finasteride 5Mg tablets for 12 weeks: finasteride 5mg tablets 12 weeks prior to focal therapy
|
CHRONOS B - Arm 5 (Intervention)
n=21 Participants
Neoadjuvant bicalutamide 50mg once daily therapy for a minimum of 12 weeks followed by focal therapy (as per control arm).
Focal therapy after Bicalutamide 50Mg tablets for 12 weeks: Bicalutamide 50mg per day - 12 weeks prior to focal therapy
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
68.78 years
STANDARD_DEVIATION 7.64 • n=18 Participants
|
69.28 years
STANDARD_DEVIATION 4.6 • n=18 Participants
|
64.55 years
STANDARD_DEVIATION 7.0 • n=22 Participants
|
66.52 years
STANDARD_DEVIATION 7.53 • n=21 Participants
|
66.71 years
STANDARD_DEVIATION 6.80 • n=21 Participants
|
66.8 years
STANDARD_DEVIATION 6.9 • n=100 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=18 Participants
|
18 Participants
n=18 Participants
|
22 Participants
n=22 Participants
|
21 Participants
n=21 Participants
|
21 Participants
n=21 Participants
|
100 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
White
|
8 Participants
n=18 Participants
|
13 Participants
n=18 Participants
|
14 Participants
n=22 Participants
|
17 Participants
n=21 Participants
|
15 Participants
n=21 Participants
|
67 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
Mixed
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=22 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=22 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=22 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=22 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
8 Participants
n=18 Participants
|
5 Participants
n=18 Participants
|
5 Participants
n=22 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=21 Participants
|
25 Participants
n=100 Participants
|
|
IMD Decile
Decile 1
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=22 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=100 Participants
|
|
IMD Decile
Decile 2
|
0 Participants
n=18 Participants
|
1 Participants
n=18 Participants
|
2 Participants
n=22 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=100 Participants
|
|
IMD Decile
Decile 3
|
1 Participants
n=18 Participants
|
1 Participants
n=18 Participants
|
1 Participants
n=22 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=100 Participants
|
|
IMD Decile
Decile 4
|
2 Participants
n=18 Participants
|
1 Participants
n=18 Participants
|
4 Participants
n=22 Participants
|
3 Participants
n=21 Participants
|
6 Participants
n=21 Participants
|
16 Participants
n=100 Participants
|
|
IMD Decile
Decile 5
|
2 Participants
n=18 Participants
|
2 Participants
n=18 Participants
|
4 Participants
n=22 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=21 Participants
|
15 Participants
n=100 Participants
|
|
IMD Decile
Decile 6
|
2 Participants
n=18 Participants
|
2 Participants
n=18 Participants
|
3 Participants
n=22 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=21 Participants
|
8 Participants
n=100 Participants
|
|
IMD Decile
Decile 7
|
2 Participants
n=18 Participants
|
4 Participants
n=18 Participants
|
1 Participants
n=22 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=21 Participants
|
12 Participants
n=100 Participants
|
|
IMD Decile
Decile 8
|
3 Participants
n=18 Participants
|
4 Participants
n=18 Participants
|
2 Participants
n=22 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=21 Participants
|
16 Participants
n=100 Participants
|
|
IMD Decile
Decile 9
|
3 Participants
n=18 Participants
|
1 Participants
n=18 Participants
|
4 Participants
n=22 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=21 Participants
|
12 Participants
n=100 Participants
|
|
IMD Decile
Decile 10
|
3 Participants
n=18 Participants
|
2 Participants
n=18 Participants
|
1 Participants
n=22 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=21 Participants
|
11 Participants
n=100 Participants
|
|
IMD Decile
Missing from eCRF
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=100 Participants
|
|
Digital Rectal Examination
Yes
|
6 Participants
n=18 Participants
|
9 Participants
n=18 Participants
|
7 Participants
n=22 Participants
|
7 Participants
n=21 Participants
|
8 Participants
n=21 Participants
|
37 Participants
n=100 Participants
|
|
Digital Rectal Examination
Normal Findings
|
3 Participants
n=18 Participants
|
5 Participants
n=18 Participants
|
4 Participants
n=22 Participants
|
3 Participants
n=21 Participants
|
6 Participants
n=21 Participants
|
21 Participants
n=100 Participants
|
|
Digital Rectal Examination
Abnormal Findings
|
3 Participants
n=18 Participants
|
4 Participants
n=18 Participants
|
3 Participants
n=22 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=21 Participants
|
16 Participants
n=100 Participants
|
|
Digital Rectal Examination
No
|
12 Participants
n=18 Participants
|
8 Participants
n=18 Participants
|
15 Participants
n=22 Participants
|
14 Participants
n=21 Participants
|
13 Participants
n=21 Participants
|
62 Participants
n=100 Participants
|
|
Digital Rectal Examination
Missing from eCRF
|
0 Participants
n=18 Participants
|
1 Participants
n=18 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=100 Participants
|
|
Current Medication
Yes
|
11 Participants
n=18 Participants
|
12 Participants
n=18 Participants
|
13 Participants
n=22 Participants
|
15 Participants
n=21 Participants
|
12 Participants
n=21 Participants
|
63 Participants
n=100 Participants
|
|
Current Medication
No
|
5 Participants
n=18 Participants
|
3 Participants
n=18 Participants
|
9 Participants
n=22 Participants
|
6 Participants
n=21 Participants
|
9 Participants
n=21 Participants
|
32 Participants
n=100 Participants
|
|
Current Medication
Missing from eCRF
|
2 Participants
n=18 Participants
|
3 Participants
n=18 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=100 Participants
|
|
5 alpha-reductase inhibitor
Yes over (or equal to) 6 months ago
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=22 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=100 Participants
|
|
5 alpha-reductase inhibitor
Yes within 6 months
|
0 Participants
n=18 Participants
|
1 Participants
n=18 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=100 Participants
|
|
5 alpha-reductase inhibitor
No
|
16 Participants
n=18 Participants
|
14 Participants
n=18 Participants
|
22 Participants
n=22 Participants
|
20 Participants
n=21 Participants
|
21 Participants
n=21 Participants
|
93 Participants
n=100 Participants
|
|
5 alpha-reductase inhibitor
Missing from eCRF
|
2 Participants
n=18 Participants
|
3 Participants
n=18 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=100 Participants
|
|
Tumour Grade
Gleason 3+3
|
1 Participants
n=18 Participants
|
1 Participants
n=18 Participants
|
2 Participants
n=22 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=21 Participants
|
6 Participants
n=100 Participants
|
|
Tumour Grade
Gleason 3+4
|
14 Participants
n=18 Participants
|
13 Participants
n=18 Participants
|
16 Participants
n=22 Participants
|
16 Participants
n=21 Participants
|
17 Participants
n=21 Participants
|
76 Participants
n=100 Participants
|
|
Tumour Grade
Gleason 4+3
|
3 Participants
n=18 Participants
|
4 Participants
n=18 Participants
|
4 Participants
n=22 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=21 Participants
|
18 Participants
n=100 Participants
|
|
Local Stage
Clinical T2/Radiological stage <T3a
|
18 Participants
n=18 Participants
|
18 Participants
n=18 Participants
|
20 Participants
n=22 Participants
|
19 Participants
n=21 Participants
|
18 Participants
n=21 Participants
|
93 Participants
n=100 Participants
|
|
Local Stage
Radiological T3a
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
2 Participants
n=22 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=21 Participants
|
7 Participants
n=100 Participants
|
|
Previous or current 5ARI use?
Yes
|
0 Participants
n=18 Participants • Only CHRONOS A used 5ARI. This was an exclusion criteria for B
|
1 Participants
n=18 Participants • Only CHRONOS A used 5ARI. This was an exclusion criteria for B
|
0 Participants
Only CHRONOS A used 5ARI. This was an exclusion criteria for B
|
0 Participants
Only CHRONOS A used 5ARI. This was an exclusion criteria for B
|
0 Participants
Only CHRONOS A used 5ARI. This was an exclusion criteria for B
|
1 Participants
n=36 Participants • Only CHRONOS A used 5ARI. This was an exclusion criteria for B
|
|
Previous or current 5ARI use?
No
|
18 Participants
n=18 Participants • Only CHRONOS A used 5ARI. This was an exclusion criteria for B
|
17 Participants
n=18 Participants • Only CHRONOS A used 5ARI. This was an exclusion criteria for B
|
0 Participants
Only CHRONOS A used 5ARI. This was an exclusion criteria for B
|
0 Participants
Only CHRONOS A used 5ARI. This was an exclusion criteria for B
|
0 Participants
Only CHRONOS A used 5ARI. This was an exclusion criteria for B
|
35 Participants
n=36 Participants • Only CHRONOS A used 5ARI. This was an exclusion criteria for B
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The count of participants recruited and randomised per month per centre (CHRONOS-A and CHRONOS-B separately)
To assess the acceptance of randomisation to the allocated arm within CHRONOS A \& CHRONOS B separately using rates of compliance, and rates of withdrawal
Outcome measures
| Measure |
CHRONOS A - Arm 1 (Control)
n=18 Participants
• Arm 1 (Control): 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 was allowed. In patients undergoing radical prostatectomy, cytoreduction a maximum of 6 months with medication was permissible, provided this was part of local practice.
|
CHRONOS A - Arm 2 (Intervention)
n=18 Participants
• Arm 2 (Intervention): 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 was allowed as part of the focal therapy intervention.
|
CHRONOS B - Arm 3 (Control)
n=22 Participants
• Arm 1 (Control): Focal therapy alone (high intensity focused ultrasound \[HIFU\] or cryotherapy as per physician and centre choice). A second treatment in-field, or a first focal ablation to an out-of-field progressive or de novo lesion was allowed but were regarded as failure events for the purpose of CHRONOS-B.
|
CHRONOS B - Arm 4 (Intervention):
n=21 Participants
• Arm 2 (Intervention): Neoadjuvant finasteride 5mg once daily for a minimum of 12 weeks followed by focal therapy (as per control arm).
|
CHRONOS B - Arm 5 (Intervention)
n=21 Participants
Arm 3 (Intervention): Neoadjuvant bicalutamide 50mg once daily therapy for a minimum of 12 weeks followed by focal therapy (as per control arm).
|
|---|---|---|---|---|---|
|
Pilot: Acceptance of Randomisation to Allocated Arm Within CHRONOS A & CHRONOS B
King's College Hospital NHS Foundation Trust
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Pilot: Acceptance of Randomisation to Allocated Arm Within CHRONOS A & CHRONOS B
Charing Cross Hospital
|
4 Participants
|
0 Participants
|
11 Participants
|
10 Participants
|
11 Participants
|
|
Pilot: Acceptance of Randomisation to Allocated Arm Within CHRONOS A & CHRONOS B
University Hospital Southampton NHS Foundation Trust
|
11 Participants
|
8 Participants
|
8 Participants
|
9 Participants
|
5 Participants
|
|
Pilot: Acceptance of Randomisation to Allocated Arm Within CHRONOS A & CHRONOS B
Sunderland Royal Hospital
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Pilot: Acceptance of Randomisation to Allocated Arm Within CHRONOS A & CHRONOS B
Ashford & St Peter's Hospitals NHS Foundation Trust
|
0 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Pilot: Acceptance of Randomisation to Allocated Arm Within CHRONOS A & CHRONOS B
Royal Marsden Hospital NHS Foundation Trust
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Pilot: Acceptance of Randomisation to Allocated Arm Within CHRONOS A & CHRONOS B
Hampshire Hospital NHS Foundation Trust
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Pilot: Acceptance of Randomisation to Allocated Arm Within CHRONOS A & CHRONOS B
Kingston Hospital NHS Foundation Trust
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Pilot: Acceptance of Randomisation to Allocated Arm Within CHRONOS A & CHRONOS B
West Middlesex University Hospital
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Pilot: Acceptance of Randomisation to Allocated Arm Within CHRONOS A & CHRONOS B
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Recruitment rates of CHRONOS-A and CHRONOS-B and their corresponding 95% confidence intervals
To estimate the recruitment rate to CHRONOS A \& CHRONOS B and their corresponding 95% confidence intervals The recruitment rate is defined as number recruited (consented) over total number of patients approached.
Outcome measures
| Measure |
CHRONOS A - Arm 1 (Control)
n=211 Participants
• Arm 1 (Control): 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 was allowed. In patients undergoing radical prostatectomy, cytoreduction a maximum of 6 months with medication was permissible, provided this was part of local practice.
|
CHRONOS A - Arm 2 (Intervention)
n=211 Participants
• Arm 2 (Intervention): 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 was allowed as part of the focal therapy intervention.
|
CHRONOS B - Arm 3 (Control)
n=148 Participants
• Arm 1 (Control): Focal therapy alone (high intensity focused ultrasound \[HIFU\] or cryotherapy as per physician and centre choice). A second treatment in-field, or a first focal ablation to an out-of-field progressive or de novo lesion was allowed but were regarded as failure events for the purpose of CHRONOS-B.
|
CHRONOS B - Arm 4 (Intervention):
n=148 Participants
• Arm 2 (Intervention): Neoadjuvant finasteride 5mg once daily for a minimum of 12 weeks followed by focal therapy (as per control arm).
|
CHRONOS B - Arm 5 (Intervention)
n=148 Participants
Arm 3 (Intervention): Neoadjuvant bicalutamide 50mg once daily therapy for a minimum of 12 weeks followed by focal therapy (as per control arm).
|
|---|---|---|---|---|---|
|
Pilot: Recruitment Rate to CHRONOS A & CHRONOS B and Their Corresponding 95% Confidence Intervals
|
8.5 percentage of participants
Interval 5.1 to 13.1
|
8.5 percentage of participants
Interval 5.1 to 13.1
|
14.9 percentage of participants
Interval 9.6 to 21.6
|
14.2 percentage of participants
Interval 9.0 to 20.9
|
14.2 percentage of participants
Interval 9.0 to 20.9
|
PRIMARY outcome
Timeframe: 12 monthsTo determine the treatment compliance of patients to receiving the treatment they have been allocated to through randomisation within CHRONOS A only and corresponding 95% confidence interval. CHRONOS B results provided in a separate table
Outcome measures
| Measure |
CHRONOS A - Arm 1 (Control)
n=18 Participants
• Arm 1 (Control): 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 was allowed. In patients undergoing radical prostatectomy, cytoreduction a maximum of 6 months with medication was permissible, provided this was part of local practice.
|
CHRONOS A - Arm 2 (Intervention)
n=18 Participants
• Arm 2 (Intervention): 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 was allowed as part of the focal therapy intervention.
|
CHRONOS B - Arm 3 (Control)
• Arm 1 (Control): Focal therapy alone (high intensity focused ultrasound \[HIFU\] or cryotherapy as per physician and centre choice). A second treatment in-field, or a first focal ablation to an out-of-field progressive or de novo lesion was allowed but were regarded as failure events for the purpose of CHRONOS-B.
|
CHRONOS B - Arm 4 (Intervention):
• Arm 2 (Intervention): Neoadjuvant finasteride 5mg once daily for a minimum of 12 weeks followed by focal therapy (as per control arm).
|
CHRONOS B - Arm 5 (Intervention)
Arm 3 (Intervention): Neoadjuvant bicalutamide 50mg once daily therapy for a minimum of 12 weeks followed by focal therapy (as per control arm).
|
|---|---|---|---|---|---|
|
Pilot: Treatment Compliance to CHRONOS - A
|
72.2 percentage of participants
Interval 46.5 to 90.3
|
88.9 percentage of participants
Interval 65.3 to 98.6
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 monthsTo determine the treatment compliance of patients to receiving the treatment they have been allocated to through randomisation within CHRONOS B only and corresponding 95% confidence interval CHRONOS A results provided in a separate table
Outcome measures
| Measure |
CHRONOS A - Arm 1 (Control)
n=22 Participants
• Arm 1 (Control): 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 was allowed. In patients undergoing radical prostatectomy, cytoreduction a maximum of 6 months with medication was permissible, provided this was part of local practice.
|
CHRONOS A - Arm 2 (Intervention)
n=21 Participants
• Arm 2 (Intervention): 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 was allowed as part of the focal therapy intervention.
|
CHRONOS B - Arm 3 (Control)
n=21 Participants
• Arm 1 (Control): Focal therapy alone (high intensity focused ultrasound \[HIFU\] or cryotherapy as per physician and centre choice). A second treatment in-field, or a first focal ablation to an out-of-field progressive or de novo lesion was allowed but were regarded as failure events for the purpose of CHRONOS-B.
|
CHRONOS B - Arm 4 (Intervention):
• Arm 2 (Intervention): Neoadjuvant finasteride 5mg once daily for a minimum of 12 weeks followed by focal therapy (as per control arm).
|
CHRONOS B - Arm 5 (Intervention)
Arm 3 (Intervention): Neoadjuvant bicalutamide 50mg once daily therapy for a minimum of 12 weeks followed by focal therapy (as per control arm).
|
|---|---|---|---|---|---|
|
Pilot: Treatment Compliance (CHRONOS-B)
|
100 percentage of participants
Interval 84.6 to 100.0
|
100 percentage of participants
Interval 83.9 to 100.0
|
100 percentage of participants
Interval 83.9 to 100.0
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: CHRONOS B- Arm 3 was not included in the analysis as it was the control and therefore non-IMP. CHRONOS A - Arm 1 \& Arm 2 not included as they are non-IMP
To determine patients drug compliance to allocated IMP treatment within randomisation of CHRONOS-B Arm 4 and Arm 5 only as CHRONOS -B Arm 3 is non-IMP. CHRONOS Arm A is not included as both arms are non-IMP
Outcome measures
| Measure |
CHRONOS A - Arm 1 (Control)
n=21 Participants
• Arm 1 (Control): 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 was allowed. In patients undergoing radical prostatectomy, cytoreduction a maximum of 6 months with medication was permissible, provided this was part of local practice.
|
CHRONOS A - Arm 2 (Intervention)
n=21 Participants
• Arm 2 (Intervention): 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 was allowed as part of the focal therapy intervention.
|
CHRONOS B - Arm 3 (Control)
• Arm 1 (Control): Focal therapy alone (high intensity focused ultrasound \[HIFU\] or cryotherapy as per physician and centre choice). A second treatment in-field, or a first focal ablation to an out-of-field progressive or de novo lesion was allowed but were regarded as failure events for the purpose of CHRONOS-B.
|
CHRONOS B - Arm 4 (Intervention):
• Arm 2 (Intervention): Neoadjuvant finasteride 5mg once daily for a minimum of 12 weeks followed by focal therapy (as per control arm).
|
CHRONOS B - Arm 5 (Intervention)
Arm 3 (Intervention): Neoadjuvant bicalutamide 50mg once daily therapy for a minimum of 12 weeks followed by focal therapy (as per control arm).
|
|---|---|---|---|---|---|
|
Drug Compliance to CHRONOS-B Only
Returned empty blister packs
|
33.3 percentage of participants
Interval 14.6 to 57.0
|
23.8 percentage of participants
Interval 8.2 to 47.2
|
—
|
—
|
—
|
|
Drug Compliance to CHRONOS-B Only
Patients given the IMP
|
100 percentage of participants
Interval 83.9 to 100.0
|
100 percentage of participants
Interval 83.9 to 100.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Randomisation rates of CHRONOS-A and CHRONOS-B and their corresponding 95% confidence intervals
To estimate the randomisation rate to CHRONOS A \& CHRONOS B and their corresponding 95% confidence intervals The Randomisation rate is defined as number of randomised patients over total number of patients recruited (consented)
Outcome measures
| Measure |
CHRONOS A - Arm 1 (Control)
n=18 Participants
• Arm 1 (Control): 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 was allowed. In patients undergoing radical prostatectomy, cytoreduction a maximum of 6 months with medication was permissible, provided this was part of local practice.
|
CHRONOS A - Arm 2 (Intervention)
n=18 Participants
• Arm 2 (Intervention): 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 was allowed as part of the focal therapy intervention.
|
CHRONOS B - Arm 3 (Control)
n=22 Participants
• Arm 1 (Control): Focal therapy alone (high intensity focused ultrasound \[HIFU\] or cryotherapy as per physician and centre choice). A second treatment in-field, or a first focal ablation to an out-of-field progressive or de novo lesion was allowed but were regarded as failure events for the purpose of CHRONOS-B.
|
CHRONOS B - Arm 4 (Intervention):
n=21 Participants
• Arm 2 (Intervention): Neoadjuvant finasteride 5mg once daily for a minimum of 12 weeks followed by focal therapy (as per control arm).
|
CHRONOS B - Arm 5 (Intervention)
n=21 Participants
Arm 3 (Intervention): Neoadjuvant bicalutamide 50mg once daily therapy for a minimum of 12 weeks followed by focal therapy (as per control arm).
|
|---|---|---|---|---|---|
|
Pilot: Randomisation Rate to CHRONOS A & CHRONOS B and Their Corresponding 95% Confidence Intervals
|
48.6 percentage of participants
Interval 31.9 to 65.6
|
48.6 percentage of participants
Interval 31.9 to 65.6
|
34.4 percentage of participants
Interval 22.9 to 47.3
|
32.8 percentage of participants
Interval 21.6 to 45.7
|
32.8 percentage of participants
Interval 21.6 to 45.7
|
Adverse Events
CHRONOS A - Arm 1 (Control)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
CHRONOS A - Arm 2 (Intervention) Focal Therapy Alone
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
CHRONOS B - Arm 1 (Control) Focal Therapy Alone
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
CHRONOS B - Arm 2 (Intervention) Neoadjuvant Finasteride 5mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
CHRONOS B - Arm 3 (Intervention) Neoadjuvant Bicalutamide 50mg
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CHRONOS A - Arm 1 (Control)
n=18 participants at risk
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.
Radical therapy (radiotherapy or prostatectomy \[radiotherapy can be external beam or brachytherapy\]: Radical therapy (radiotherapy or prostatectomy \[radiotherapy can be external beam or brachytherapy\]
|
CHRONOS A - Arm 2 (Intervention) Focal Therapy Alone
n=18 participants at risk
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.
Focal therapy: Focal therapy (high intensity focused ultrasound or cryotherapy)
|
CHRONOS B - Arm 1 (Control) Focal Therapy Alone
n=22 participants at risk
Focal therapy alone (high intensity focused ultrasound \[HIFU\] or cryotherapy as per physician and centre choice). A second treatment in-field, or a first focal ablation to an out-of-field progressive or de novo lesion will be allowed but will be regarded as failure events for the purpose of CHRONOS-B.
Radical therapy (radiotherapy or prostatectomy \[radiotherapy can be external beam or brachytherapy\]: Radical therapy (radiotherapy or prostatectomy \[radiotherapy can be external beam or brachytherapy\]
|
CHRONOS B - Arm 2 (Intervention) Neoadjuvant Finasteride 5mg
n=21 participants at risk
Neoadjuvant finasteride 5mg once daily for a minimum of 12 weeks followed by focal therapy (as per CHRONOS B control arm).
Focal therapy after Finasteride 5Mg tablets for 12 weeks: finasteride 5mg tablets 12 weeks prior to focal therapy
|
CHRONOS B - Arm 3 (Intervention) Neoadjuvant Bicalutamide 50mg
n=21 participants at risk
Neoadjuvant bicalutamide 50mg once daily therapy for a minimum of 12 weeks followed by focal therapy (as per control arm).
Focal therapy after Bicalutamide 50Mg tablets for 12 weeks: Bicalutamide 50mg per day - 12 weeks prior to focal therapy
|
|---|---|---|---|---|---|
|
Renal and urinary disorders
Iatrogenic scrotal oedema (Primary)
|
0.00%
0/18 • 1 year, 10 months
|
5.6%
1/18 • Number of events 1 • 1 year, 10 months
|
0.00%
0/22 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
Renal and urinary disorders
Acute Urinary retention
|
5.6%
1/18 • Number of events 1 • 1 year, 10 months
|
0.00%
0/18 • 1 year, 10 months
|
0.00%
0/22 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
Renal and urinary disorders
Paraphimosis
|
5.6%
1/18 • Number of events 1 • 1 year, 10 months
|
0.00%
0/18 • 1 year, 10 months
|
0.00%
0/22 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
Renal and urinary disorders
urosepsis
|
0.00%
0/18 • 1 year, 10 months
|
0.00%
0/18 • 1 year, 10 months
|
4.5%
1/22 • Number of events 1 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
Renal and urinary disorders
Bacterial Cellulitis and Related Condition
|
0.00%
0/18 • 1 year, 10 months
|
0.00%
0/18 • 1 year, 10 months
|
4.5%
1/22 • Number of events 1 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
Cardiac disorders
Pleuritic chest pain
|
0.00%
0/18 • 1 year, 10 months
|
0.00%
0/18 • 1 year, 10 months
|
4.5%
1/22 • Number of events 1 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
Renal and urinary disorders
Visible haematuria
|
0.00%
0/18 • 1 year, 10 months
|
0.00%
0/18 • 1 year, 10 months
|
0.00%
0/22 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
|
Metabolism and nutrition disorders
Torsades de Pointes
|
0.00%
0/18 • 1 year, 10 months
|
0.00%
0/18 • 1 year, 10 months
|
0.00%
0/22 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/18 • 1 year, 10 months
|
0.00%
0/18 • 1 year, 10 months
|
0.00%
0/22 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
|
Gastrointestinal disorders
Infection due to common bile duct stones
|
0.00%
0/18 • 1 year, 10 months
|
0.00%
0/18 • 1 year, 10 months
|
0.00%
0/22 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
|
Renal and urinary disorders
Common bile duct stones
|
0.00%
0/18 • 1 year, 10 months
|
0.00%
0/18 • 1 year, 10 months
|
0.00%
0/22 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
9.5%
2/21 • Number of events 2 • 1 year, 10 months
|
|
Cardiac disorders
Aortic stenosis
|
0.00%
0/18 • 1 year, 10 months
|
0.00%
0/18 • 1 year, 10 months
|
0.00%
0/22 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
Other adverse events
| Measure |
CHRONOS A - Arm 1 (Control)
n=18 participants at risk
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.
Radical therapy (radiotherapy or prostatectomy \[radiotherapy can be external beam or brachytherapy\]: Radical therapy (radiotherapy or prostatectomy \[radiotherapy can be external beam or brachytherapy\]
|
CHRONOS A - Arm 2 (Intervention) Focal Therapy Alone
n=18 participants at risk
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.
Focal therapy: Focal therapy (high intensity focused ultrasound or cryotherapy)
|
CHRONOS B - Arm 1 (Control) Focal Therapy Alone
n=22 participants at risk
Focal therapy alone (high intensity focused ultrasound \[HIFU\] or cryotherapy as per physician and centre choice). A second treatment in-field, or a first focal ablation to an out-of-field progressive or de novo lesion will be allowed but will be regarded as failure events for the purpose of CHRONOS-B.
Radical therapy (radiotherapy or prostatectomy \[radiotherapy can be external beam or brachytherapy\]: Radical therapy (radiotherapy or prostatectomy \[radiotherapy can be external beam or brachytherapy\]
|
CHRONOS B - Arm 2 (Intervention) Neoadjuvant Finasteride 5mg
n=21 participants at risk
Neoadjuvant finasteride 5mg once daily for a minimum of 12 weeks followed by focal therapy (as per CHRONOS B control arm).
Focal therapy after Finasteride 5Mg tablets for 12 weeks: finasteride 5mg tablets 12 weeks prior to focal therapy
|
CHRONOS B - Arm 3 (Intervention) Neoadjuvant Bicalutamide 50mg
n=21 participants at risk
Neoadjuvant bicalutamide 50mg once daily therapy for a minimum of 12 weeks followed by focal therapy (as per control arm).
Focal therapy after Bicalutamide 50Mg tablets for 12 weeks: Bicalutamide 50mg per day - 12 weeks prior to focal therapy
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
1/14 • Number of events 1 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
|
Immune system disorders
Allergic reaction to Penicillin
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
|
Cardiac disorders
Aortic stenosis
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
|
Infections and infestations
Bacterial Cellulitis and Related Conditions
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
Renal and urinary disorders
Blood from urethral meatus when straining
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
Infections and infestations
Campylobacter
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
|
Infections and infestations
Chest infection
|
0.00%
0/14 • 1 year, 10 months
|
6.2%
1/16 • Number of events 1 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
Infections and infestations
Complications of urinary catheter
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
9.5%
2/21 • Number of events 2 • 1 year, 10 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
Immune system disorders
COVID
|
0.00%
0/14 • 1 year, 10 months
|
6.2%
1/16 • Number of events 1 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
|
General disorders
Dry ongoing cough, Chest xray clear
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
|
Renal and urinary disorders
Dry Orgasm
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
Renal and urinary disorders
Ejaculatory dysfunction
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
|
Renal and urinary disorders
Elective (planned) parathyroidectomy
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
|
Renal and urinary disorders
Epididymo-orchitis
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
Renal and urinary disorders
Erectile Dysfunction
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
28.6%
6/21 • Number of events 6 • 1 year, 10 months
|
14.3%
3/21 • Number of events 3 • 1 year, 10 months
|
28.6%
6/21 • Number of events 6 • 1 year, 10 months
|
|
Renal and urinary disorders
Failed removal of common bile duct stones
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
|
General disorders
Fatigue
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
9.5%
2/21 • Number of events 2 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
Renal and urinary disorders
Haemtospermia
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/14 • 1 year, 10 months
|
6.2%
1/16 • Number of events 1 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
Renal and urinary disorders
Iatrogenic Scrotal Oedema
|
0.00%
0/14 • 1 year, 10 months
|
6.2%
1/16 • Number of events 1 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
Infections and infestations
Infection following tooth extraction
|
0.00%
0/14 • 1 year, 10 months
|
6.2%
1/16 • Number of events 1 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
General disorders
Knee Replacement
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
|
Renal and urinary disorders
Low urinary flow rate
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
Renal and urinary disorders
Lower Urinary Tract Symptoms
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
14.3%
3/21 • Number of events 3 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
General disorders
Nocturia
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
General disorders
Painful nipples
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
|
Renal and urinary disorders
Painless swelling and mild bruising of scrotal and penile skin
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
Blood and lymphatic system disorders
pancytopenia
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
Renal and urinary disorders
Paraphimosis
|
7.1%
1/14 • Number of events 1 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
Renal and urinary disorders
bladder malignancy
|
7.1%
1/14 • Number of events 1 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
Renal and urinary disorders
patient required TURP after urosepsis and retention
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
Renal and urinary disorders
Penile numbness
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
Renal and urinary disorders
Penile tip pain
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
|
Cardiac disorders
Pleuritic Chest Pain - Bilateral pulmonary emboli on CT imaging
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
Renal and urinary disorders
Post HIFU Prostate Inflammation
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
Psychiatric disorders
Post traumatic stress disorder
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
|
Renal and urinary disorders
Prostatitis
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
|
General disorders
Reaction to Ciprofloxacin (Nausea and Vomiting)
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
Renal and urinary disorders
Rectal fissure
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
|
Renal and urinary disorders
Removal of stones from common bile duct
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
|
Renal and urinary disorders
Severe LUTS
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
Psychiatric disorders
Short term memory loss
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
|
Cardiac disorders
stroke
|
0.00%
0/14 • 1 year, 10 months
|
6.2%
1/16 • Number of events 1 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
Renal and urinary disorders
Suspected common bile duct stone/pancreatitis,serum amylase raised
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
|
Renal and urinary disorders
Sweaty testicles
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
Renal and urinary disorders
Swollen testicles
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
Cardiac disorders
Torsades de Pointes
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
|
Renal and urinary disorders
Urgency of micturition
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
|
Renal and urinary disorders
Urinary Retention
|
7.1%
1/14 • Number of events 1 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
14.3%
3/21 • Number of events 3 • 1 year, 10 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/14 • 1 year, 10 months
|
6.2%
1/16 • Number of events 1 • 1 year, 10 months
|
9.5%
2/21 • Number of events 2 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
42.9%
9/21 • Number of events 9 • 1 year, 10 months
|
|
Renal and urinary disorders
Urine leaking around catheter - ?catheter blocked, requires flushing.
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
Infections and infestations
UTI, epididymo-orchitis
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
|
Renal and urinary disorders
Visible haematuria
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
9.5%
2/21 • Number of events 2 • 1 year, 10 months
|
|
General disorders
Worsening night sweats
|
0.00%
0/14 • 1 year, 10 months
|
0.00%
0/16 • 1 year, 10 months
|
4.8%
1/21 • Number of events 1 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
0.00%
0/21 • 1 year, 10 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place