Trial Outcomes & Findings for PROState Pathway Embedded Comparative Trial (NCT NCT04400656)
NCT ID: NCT04400656
Last Updated: 2025-06-18
Results Overview
Number of men who consented to inclusion in PROSPECT Study out of total number of patients approached at the original point of contact by the research team.
Recruitment status
COMPLETED
Target enrollment
139 participants
Primary outcome timeframe
from baseline to 23 months
Results posted on
2025-06-18
Participant Flow
Acceptability and Feasibility sample size: 80 patients. However the actual cohort sample will not be restricted as the overall number needed will be dependent on future randomised interventions and therefore there is no maximum number. If the feasibility number is met then we will continue recruiting for the entire recruitment period with no upper limit on numbers and continue beyond the existing recruitment period if further funding allows and pending approval by REC.
Participant milestones
| Measure |
Acceptability and Feasibility Group
Men who have been referred for further investigation due to elevated PSA, lower urinary tract symptoms or abnormal rectal examinations
|
|---|---|
|
Overall Study
STARTED
|
139
|
|
Overall Study
COMPLETED
|
139
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
37 entries missing from eCRF
Baseline characteristics by cohort
| Measure |
Feasibility Group - Age, Ethnicity, BMI, PSA DRE & WHO Performance Status
n=139 Participants
Feasibility Group- patients referred for prostate investigations.
Age, Ethnicity, BMI, PSA DRE \& WHO Performance Status
|
|---|---|
|
Age, Continuous
|
66.4 years
STANDARD_DEVIATION 7.4 • n=139 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=139 Participants
|
|
Sex: Female, Male
Male
|
139 Participants
n=139 Participants
|
|
Race/Ethnicity, Customized
White
|
116 participants
n=139 Participants
|
|
Race/Ethnicity, Customized
Mixed / Multiple Ethnic Groups
|
2 participants
n=139 Participants
|
|
Race/Ethnicity, Customized
Asian / Asian British
|
7 participants
n=139 Participants
|
|
Race/Ethnicity, Customized
Black / African / Caribbean / Black British
|
4 participants
n=139 Participants
|
|
Race/Ethnicity, Customized
Other Ethnic Group
|
5 participants
n=139 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
5 participants
n=139 Participants
|
|
BMI
|
26.31 kg/m^2
STANDARD_DEVIATION 5.14 • n=102 Participants • 37 entries missing from eCRF
|
|
PSA
|
6.41 ng/mL
STANDARD_DEVIATION 3.28 • n=138 Participants • 1 entry missing from eCRF
|
|
DRE
No
|
96 participants
n=129 Participants • 10 entries missing from eCRF
|
|
DRE
Yes- (but DRE result missing)
|
1 participants
n=129 Participants • 10 entries missing from eCRF
|
|
DRE
Yes-Abnormal
|
7 participants
n=129 Participants • 10 entries missing from eCRF
|
|
DRE
Yes-Evidence for Locally Advanced/Metastatic Disease
|
1 participants
n=129 Participants • 10 entries missing from eCRF
|
|
DRE
Yes-Normal
|
24 participants
n=129 Participants • 10 entries missing from eCRF
|
|
WHO Performance Status
0
|
125 participants
n=138 Participants • 1 entry missing from the eCRF
|
|
WHO Performance Status
1
|
10 participants
n=138 Participants • 1 entry missing from the eCRF
|
|
WHO Performance Status
2
|
3 participants
n=138 Participants • 1 entry missing from the eCRF
|
PRIMARY outcome
Timeframe: from baseline to 23 monthsPopulation: Number analysed in the approached rate refers to the number of patients reffered to the study but may not have joined the study.
Number of men who consented to inclusion in PROSPECT Study out of total number of patients approached at the original point of contact by the research team.
Outcome measures
| Measure |
Acceptability Endpoint - Consent Rate
n=384 Participants
Proportion of patients who consented to inclusion in PROSPECT cohort out of total number of patients approached
|
Completeness of EQ5D-5L Data - Proportion Completed
Participants will be given a standard Quality of Life Questionnaire (EQ5D-5L) at the point at which they consent to inclusion into PROSPECT. We will calculate the completeness of this data one year after opening and on an ongoing basis.
|
|---|---|---|
|
Number of Men Who Consented to Inclusion in PROSPECT Study Out of Total Number of Patients Approached
|
36.2 percentage of participants
Interval 31.4 to 41.2
|
—
|
PRIMARY outcome
Timeframe: from baseline to 23 monthsEvaluation of the number of men approached to enter the PROSPECT Study from the number of men referred to the participating centres for investigation of prostate cancer.
Outcome measures
| Measure |
Acceptability Endpoint - Consent Rate
n=462 Participants
Proportion of patients who consented to inclusion in PROSPECT cohort out of total number of patients approached
|
Completeness of EQ5D-5L Data - Proportion Completed
Participants will be given a standard Quality of Life Questionnaire (EQ5D-5L) at the point at which they consent to inclusion into PROSPECT. We will calculate the completeness of this data one year after opening and on an ongoing basis.
|
|---|---|---|
|
Number of Participants Approached for the Study From the Number of Patients Referred to the Study Team by Other Participating Centres
|
83.1 percentage of participants
Interval 79.4 to 86.4
|
—
|
PRIMARY outcome
Timeframe: Questionnaire was completed at baseline - 0 months, visit 1 - 6 months, visit 2 -12 months and visit 3 -18 months.Population: Number of patients who responded/started the questionnaire \& number of patients who completed the questionnaire
Number of Participants who complete a given standard Quality of Life Questionnaire (EQ5D-5L) at the point at which they consent to inclusion into PROSPECT. (Baseline Visit)
Outcome measures
| Measure |
Acceptability Endpoint - Consent Rate
n=139 Participants
Proportion of patients who consented to inclusion in PROSPECT cohort out of total number of patients approached
|
Completeness of EQ5D-5L Data - Proportion Completed
n=139 Participants
Participants will be given a standard Quality of Life Questionnaire (EQ5D-5L) at the point at which they consent to inclusion into PROSPECT. We will calculate the completeness of this data one year after opening and on an ongoing basis.
|
|---|---|---|
|
Number of Participants Who Complete a Questionnaire on the Quality of Life (EQ5D-5L)
Visit 1 (6 months)
|
96 Participants
|
96 Participants
|
|
Number of Participants Who Complete a Questionnaire on the Quality of Life (EQ5D-5L)
Visit 2 (12 months)
|
95 Participants
|
93 Participants
|
|
Number of Participants Who Complete a Questionnaire on the Quality of Life (EQ5D-5L)
Visit 3 (18 months)
|
24 Participants
|
24 Participants
|
|
Number of Participants Who Complete a Questionnaire on the Quality of Life (EQ5D-5L)
Visit 0 (Baseline)
|
109 Participants
|
109 Participants
|
PRIMARY outcome
Timeframe: Questionnaire was completed at baseline - 0 months, visit 1 - 6 months, visit 2 -12 months and visit 3 -18 months.Population: Number of patients who responded/started the questionnaire \& number of patients who completed the questionnaire
Number of Participants who completed a given standard Quality of Life Questionnaire (EPIC-26) at the point at which they consent to inclusion into PROSPECT. (Baseline Visit)
Outcome measures
| Measure |
Acceptability Endpoint - Consent Rate
n=139 Participants
Proportion of patients who consented to inclusion in PROSPECT cohort out of total number of patients approached
|
Completeness of EQ5D-5L Data - Proportion Completed
n=139 Participants
Participants will be given a standard Quality of Life Questionnaire (EQ5D-5L) at the point at which they consent to inclusion into PROSPECT. We will calculate the completeness of this data one year after opening and on an ongoing basis.
|
|---|---|---|
|
Number of Participants Who Complete a Questionnaire on Quality of Life (EPIC-26)
Visit 0 (Baseline)
|
110 Participants
|
107 Participants
|
|
Number of Participants Who Complete a Questionnaire on Quality of Life (EPIC-26)
Visit 1 (6 months)
|
96 Participants
|
96 Participants
|
|
Number of Participants Who Complete a Questionnaire on Quality of Life (EPIC-26)
Visit 2 (12 months)
|
93 Participants
|
87 Participants
|
|
Number of Participants Who Complete a Questionnaire on Quality of Life (EPIC-26)
Visit 3 (18 months)
|
24 Participants
|
22 Participants
|
PRIMARY outcome
Timeframe: Questionnaire was completed at baseline - 0 months, visit 1 - 6 months, visit 2 -12 months and visit 3 -18 months.Population: Number of patients who responded/started the questionnaire \& number of patients who completed the questionnaire
Number of Participants who complete a given standard Quality of Life Questionnaire (IPSS) at the point at which they consent to inclusion into PROSPECT.
Outcome measures
| Measure |
Acceptability Endpoint - Consent Rate
n=139 Participants
Proportion of patients who consented to inclusion in PROSPECT cohort out of total number of patients approached
|
Completeness of EQ5D-5L Data - Proportion Completed
n=139 Participants
Participants will be given a standard Quality of Life Questionnaire (EQ5D-5L) at the point at which they consent to inclusion into PROSPECT. We will calculate the completeness of this data one year after opening and on an ongoing basis.
|
|---|---|---|
|
Number of Participants Who Complete a Questionnaire on Quality of Life (IPSS)
Visit 0 (Baseline)
|
109 Participants
|
107 Participants
|
|
Number of Participants Who Complete a Questionnaire on Quality of Life (IPSS)
Visit 1 (6 months)
|
97 Participants
|
96 Participants
|
|
Number of Participants Who Complete a Questionnaire on Quality of Life (IPSS)
Visit 2 (12 months)
|
93 Participants
|
92 Participants
|
|
Number of Participants Who Complete a Questionnaire on Quality of Life (IPSS)
Visit 3 (18 months)
|
24 Participants
|
23 Participants
|
PRIMARY outcome
Timeframe: Questionnaire was completed at baseline - 0 months, visit 1 - 6 months, visit 2 -12 months and visit 3 -18 months.Population: Number of patients who responded/started the questionnaire \& number of patients who completed the questionnaire
Number of Participants who completed a given standard Quality of Life Questionnaire (IIEF-15) at the point at which they consent to inclusion into PROSPECT. (Baseline Visit)
Outcome measures
| Measure |
Acceptability Endpoint - Consent Rate
n=139 Participants
Proportion of patients who consented to inclusion in PROSPECT cohort out of total number of patients approached
|
Completeness of EQ5D-5L Data - Proportion Completed
n=139 Participants
Participants will be given a standard Quality of Life Questionnaire (EQ5D-5L) at the point at which they consent to inclusion into PROSPECT. We will calculate the completeness of this data one year after opening and on an ongoing basis.
|
|---|---|---|
|
Number of Participants Who Complete a Questionnaire on Quality of Life (IIEF-15)
Visit 0 (Baseline)
|
107 Participants
|
99 Participants
|
|
Number of Participants Who Complete a Questionnaire on Quality of Life (IIEF-15)
Visit 1 (6 months)
|
96 Participants
|
88 Participants
|
|
Number of Participants Who Complete a Questionnaire on Quality of Life (IIEF-15)
Visit 2 (12 months)
|
91 Participants
|
86 Participants
|
|
Number of Participants Who Complete a Questionnaire on Quality of Life (IIEF-15)
Visit 3 (18 months)
|
23 Participants
|
20 Participants
|
Adverse Events
Summary of Adverse Events
Serious events: 3 serious events
Other events: 78 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Summary of Adverse Events
n=139 participants at risk
Summary of Adverse events from Feasibility Group
|
|---|---|
|
Surgical and medical procedures
Incision and drainage, hospital admission
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Injury, poisoning and procedural complications
Left Ring Finger fracture
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Psychiatric disorders
Psychosis
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
Other adverse events
| Measure |
Summary of Adverse Events
n=139 participants at risk
Summary of Adverse events from Feasibility Group
|
|---|---|
|
General disorders
Abnormal gait
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Psychiatric disorders
Anxiety
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
General disorders
Ataxia
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
General disorders
Back pain
|
1.4%
2/139 • Number of events 2 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Infections and infestations
COVID 19 infection
|
1.4%
2/139 • Number of events 2 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Renal and urinary disorders
Catheter pain
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Infections and infestations
Cellulitis
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Psychiatric disorders
Cognitive dysfunction
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Immune system disorders
Community acquired pneumonia
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Gastrointestinal disorders
Constipation
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Vascular disorders
Deep vein thrombosis
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Psychiatric disorders
Depression
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Gastrointestinal disorders
Diarrhoea and vomiting
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Renal and urinary disorders
Erectile Dysfunction
|
5.0%
7/139 • Number of events 7 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Gastrointestinal disorders
Faecal Frequency
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
General disorders
Fatigue
|
2.2%
3/139 • Number of events 3 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Gastrointestinal disorders
Flare of ulcerative Colitis
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Skin and subcutaneous tissue disorders
Groin abscess
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Renal and urinary disorders
Haematospermia
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Renal and urinary disorders
Haematuria
|
1.4%
2/139 • Number of events 2 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
General disorders
Head injury
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
General disorders
Headaches
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Renal and urinary disorders
High post void residual volumes
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Injury, poisoning and procedural complications
Hip sprain
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
General disorders
Hot flashes
|
2.2%
3/139 • Number of events 3 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Surgical and medical procedures
Inguinal Hernia repair
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Psychiatric disorders
Intermittent Confusion
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
General disorders
Knee pain
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Injury, poisoning and procedural complications
Left Ring Finger fracture
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
General disorders
Leg pain
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
General disorders
Loss of balance
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Renal and urinary disorders
Low urinary flow rate
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Renal and urinary disorders
Lower urinary tract symptoms
|
4.3%
6/139 • Number of events 6 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Renal and urinary disorders
Nocturia
|
1.4%
2/139 • Number of events 2 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Renal and urinary disorders
Perineal pain
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Renal and urinary disorders
Poor urinary flow
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Psychiatric disorders
Post traumatic epilepsy
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Psychiatric disorders
Post traumatic stress disorder
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Infections and infestations
Prostatitis
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Psychiatric disorders
Psychosis
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Renal and urinary disorders
Pyelonephritis
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Renal and urinary disorders
Recurrent Urinary Tract Infections
|
1.4%
2/139 • Number of events 2 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Renal and urinary disorders
Reduced ejaculatory volume
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Eye disorders
Retinal detachment
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
General disorders
Right groin pain
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Injury, poisoning and procedural complications
Sprained ankle
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Renal and urinary disorders
Stress Urinary Incontinence
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Surgical and medical procedures
Total hip arthroplasty
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Vascular disorders
Transient Ischaemic Attack
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Musculoskeletal and connective tissue disorders
Tremor
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Renal and urinary disorders
Urinary incontinence
|
1.4%
2/139 • Number of events 2 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
Gastrointestinal disorders
Watery stool
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
General disorders
Weight gain
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
General disorders
Worsening shortness of breath
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
|
General disorders
calf swelling
|
0.72%
1/139 • Number of events 1 • 23 months
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place