NCT00931528 · STUDY IN CONTEXT

Tadalafil in Preventing Erectile Dysfunction in Patients With Prostate Cancer Treated With Radiation Therapy

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

EF is measured by Question 1 of the International Index of Erectile Function (IIEF). The IIEF is a validated 15-item for measuring patient-reported erectile function. Question 1 asks "How often were you able to get an erection during sexual activity?" Responses ranged from 0=no sexual activity, to 5=Almost always or always. Higher scores indicated better functioning. All patients have erectile function prior to initiation of RT, indicated by a score of 3, 4, or 5 on IIEF Q1. Patients with a lower IIEF Q1 score at weeks 28-30 than at baseline will have less erectile function and be categorized as nonresponders. Patients with similar or improved erectile function will be categorized as responders (maintaining). Patient-related predictors of at erectile function at this time point are also reported with this outcome measure.

All randomized eligible patients with IIEF at both baseline and 30 week time point.

→

secondary · POSTED

The International Index of Erectile Function (IIEF) is a validated 15-item for measuring patient-reported erectile function. Question 1 asks "How often were you able to get an erection during sexual activity?" Responses ranged from 0=no sexual activity, to 5=Almost always or always. Higher scores indicated better functioning. All patients have erectile function prior to initiation of RT, indicated by a score of 3, 4, or 5. Patients with a lower IIEF Q1 score at weeks 28-30 than at baseline will have less erectile function and be categorized as nonresponders. Patients with similar or improved erectile function will be categorized as responders (maintaining). Patient-related predictors of at erectile function at Years 1 and 2 are also reported with this outcome measure.

All randomized eligible patients with IIEF at both baseline and corresponding time point.

→

secondary · POSTED

The IIEF is a validated 15-item for measuring patient-reported erectile function. A score of 0-5 is given to each of the 15 questions that examine 5 main domains of male sexual function: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Domain scores are the sum of each item. The erectile function domain has 5 items with a score range of 1-30, orgasmic function has 2 items with a score range of 0-10, sexual desire has 2 items with a score range of 0-10, intercourse satisfaction has 3 items with a score range of 0-15, and overall satisfaction has 2 items with a score range of 2-10. Total score ranges from 0-70, with higher scores indicated better functioning. Change from baseline is calculated by subtracting baseline score from score at the time point of interest.

Eligible patients with IIEF at baseline and corresponding time points.

→

secondary · POSTED

The Sexual Adjustment Questionnaire (SAQ) is a 20-item questionnaire with an overall score range between 8 and 100 including the following domains: desire, ranging between 5 and 30; dysfunction, 0 and 25; activity, 0 and 10; satisfaction, 1 and 10; and fatigue, 1 and 5. The change in SAQ score is calculated by subtracting the baseline score from the follow-up score. A positive change indicates an improvement in sexual well-being.

Eligible patients with data at baseline and corresponding time point

→

secondary · POSTED

The SAQ-P is an 18-item questionnaire with an overall score range between 0 and 90 including the following domains: desire, dysfunction, activity, satisfaction, and fatigue. The change in SAQ score is calculated by subtracting the baseline score from the follow-up score. A positive change indicates an improvement in sexual well-being.

Consenting partners of randomized eligible patients with data at baseline and corresponding time point

→

secondary · POSTED

The Locke Marital Adjustment Test (LMAT) is a 16-item questionnaire with scores ranging from 48 to 138 for participants. Higher scores indicate greater sexual function, sexual wellbeing, or marital adjustment. The change in LMAT score is calculated by subtracting the baseline score from the follow-up score.

Eligible patients with data at baseline and time point of interest.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

Patient-reported symptom or function measure · Percentage of Patients Maintaining Spontaneous (Off-drug) Erectile Function (EF) at Weeks 28-30 After Initiation of Radiation Therapy (RT)

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-prostate-cancer
nct id: NCT00931528
qol key: qol-0000
source section id: NCT00931528-om-0000
source outcome index: 0
instrument: Patient-reported symptom or function measure
instrument basis: matched 'patient-reported' in the study's own wording
scale title: Percentage of Patients Maintaining Spontaneous (Off-drug) Erectile Function (EF) at Weeks 28-30 After Initiation of Radiation Therapy (RT)
measure definition: EF is measured by Question 1 of the International Index of Erectile Function (IIEF). The IIEF is a validated 15-item for measuring patient-reported erectile function. Question 1 asks "How often were you able to get an erection during sexual activity?" Responses ranged from 0=no sexual activity, to 5=Almost always or always. Higher scores indicated better functioning. All patients have erectile function prior to initiation of RT, indicated by a score of 3, 4, or 5 on IIEF Q1. Patients with a lower IIEF Q1 score at weeks 28-30 than at baseline will have less erectile function and be categorized as nonresponders. Patients with similar or improved erectile function will be categorized as responders (maintaining). Patient-related predictors of at erectile function at this time point are also reported with this outcome measure.
time frame: Baseline and 30 weeks from the start of radiation therapy
analysis role: primary
reporting status: POSTED
higher is better: 1
direction quote: Higher scores indicated better
population note: All randomized eligible patients with IIEF at both baseline and 30 week time point.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Patient-reported symptom or function measure · Percentage of Patients Maintaining Spontaneous (Off-drug) EF at Years 1 and 2 After Initiation of RT

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-prostate-cancer
nct id: NCT00931528
qol key: qol-0001
source section id: NCT00931528-om-0001
source outcome index: 1
instrument: Patient-reported symptom or function measure
instrument basis: matched 'patient-reported' in the study's own wording
scale title: Percentage of Patients Maintaining Spontaneous (Off-drug) EF at Years 1 and 2 After Initiation of RT
measure definition: The International Index of Erectile Function (IIEF) is a validated 15-item for measuring patient-reported erectile function. Question 1 asks "How often were you able to get an erection during sexual activity?" Responses ranged from 0=no sexual activity, to 5=Almost always or always. Higher scores indicated better functioning. All patients have erectile function prior to initiation of RT, indicated by a score of 3, 4, or 5. Patients with a lower IIEF Q1 score at weeks 28-30 than at baseline will have less erectile function and be categorized as nonresponders. Patients with similar or improved erectile function will be categorized as responders (maintaining). Patient-related predictors of at erectile function at Years 1 and 2 are also reported with this outcome measure.
time frame: Baseline, 1 and 2 years from the start of tadalafil or placebo
analysis role: secondary
reporting status: POSTED
higher is better: 1
direction quote: Higher scores indicated better
population note: All randomized eligible patients with IIEF at both baseline and corresponding time point.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Patient-reported symptom or function measure · Overall Sexual Function as Measured by Change From Baseline in the International Index of Erectile Function (IIEF)

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-prostate-cancer
nct id: NCT00931528
qol key: qol-0002
source section id: NCT00931528-om-0002
source outcome index: 2
instrument: Patient-reported symptom or function measure
instrument basis: matched 'patient-reported' in the study's own wording
scale title: Overall Sexual Function as Measured by Change From Baseline in the International Index of Erectile Function (IIEF)
measure definition: The IIEF is a validated 15-item for measuring patient-reported erectile function. A score of 0-5 is given to each of the 15 questions that examine 5 main domains of male sexual function: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Domain scores are the sum of each item. The erectile function domain has 5 items with a score range of 1-30, orgasmic function has 2 items with a score range of 0-10, sexual desire has 2 items with a score range of 0-10, intercourse satisfaction has 3 items with a score range of 0-15, and overall satisfaction has 2 items with a score range of 2-10. Total score ranges from 0-70, with higher scores indicated better functioning. Change from baseline is calculated by subtracting baseline score from score at the time point of interest.
time frame: Baseline, week 30, and years 1 and 2 from start of treatment
analysis role: secondary
reporting status: POSTED
higher is better: 1
direction quote: higher scores indicated better
population note: Eligible patients with IIEF at baseline and corresponding time points.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

FACT · Radiotherapy Factors Associated With Spontaneous (Off-drug) EF at Weeks 28-30 and Years 1 and 2 After Initiation of RT

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-prostate-cancer
nct id: NCT00931528
qol key: qol-0007
source section id: NCT00931528-om-0007
source outcome index: 7
instrument: FACT
instrument basis: matched 'factors' in the study's own wording
scale title: Radiotherapy Factors Associated With Spontaneous (Off-drug) EF at Weeks 28-30 and Years 1 and 2 After Initiation of RT
measure definition: Source null
time frame: Baseline, week 30 and years 1 and 2 after the start of treatment
analysis role: exploratory
reporting status: NOT_POSTED
higher is better: Source null
direction quote: Source null
population note: Source null
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-prostate-cancer
nct id: NCT00931528
trial label: Tadalafil in Preventing Erectile Dysfunction in Patients With Prostate Cancer Treated With Radiation Therapy
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 2
qol Count: 4

outcomes

release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00931528
outcome key
om-0000
source section id
NCT00931528-om-0000
source outcome index
0
endpoint
Percentage of Patients Maintaining Spontaneous (Off-drug) Erectile Function (EF) at Weeks 28-30 After Initiation of Radiation Therapy (RT)
endpoint definition
EF is measured by Question 1 of the International Index of Erectile Function (IIEF). The IIEF is a validated 15-item for measuring patient-reported erectile function. Question 1 asks "How often were you able to get an erection during sexual activity?" Responses ranged from 0=no sexual activity, to 5=Almost always or always. Higher scores indicated better functioning. All patients have erectile function prior to initiation of RT, indicated by a score of 3, 4, or 5 on IIEF Q1. Patients with a lower IIEF Q1 score at weeks 28-30 than at baseline will have less erectile function and be categorized as nonresponders. Patients with similar or improved erectile function will be categorized as responders (maintaining). Patient-related predictors of at erectile function at this time point are also reported with this outcome measure.
time origin
Baseline and 30 weeks from the start of radiation therapy
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All randomized eligible patients with IIEF at both baseline and 30 week time point.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00931528
outcome key
om-0001
source section id
NCT00931528-om-0001
source outcome index
1
endpoint
Percentage of Patients Maintaining Spontaneous (Off-drug) EF at Years 1 and 2 After Initiation of RT
endpoint definition
The International Index of Erectile Function (IIEF) is a validated 15-item for measuring patient-reported erectile function. Question 1 asks "How often were you able to get an erection during sexual activity?" Responses ranged from 0=no sexual activity, to 5=Almost always or always. Higher scores indicated better functioning. All patients have erectile function prior to initiation of RT, indicated by a score of 3, 4, or 5. Patients with a lower IIEF Q1 score at weeks 28-30 than at baseline will have less erectile function and be categorized as nonresponders. Patients with similar or improved erectile function will be categorized as responders (maintaining). Patient-related predictors of at erectile function at Years 1 and 2 are also reported with this outcome measure.
time origin
Baseline, 1 and 2 years from the start of tadalafil or placebo
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All randomized eligible patients with IIEF at both baseline and corresponding time point.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00931528
outcome key
om-0002
source section id
NCT00931528-om-0002
source outcome index
2
endpoint
Overall Sexual Function as Measured by Change From Baseline in the International Index of Erectile Function (IIEF)
endpoint definition
The IIEF is a validated 15-item for measuring patient-reported erectile function. A score of 0-5 is given to each of the 15 questions that examine 5 main domains of male sexual function: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Domain scores are the sum of each item. The erectile function domain has 5 items with a score range of 1-30, orgasmic function has 2 items with a score range of 0-10, sexual desire has 2 items with a score range of 0-10, intercourse satisfaction has 3 items with a score range of 0-15, and overall satisfaction has 2 items with a score range of 2-10. Total score ranges from 0-70, with higher scores indicated better functioning. Change from baseline is calculated by subtracting baseline score from score at the time point of interest.
time origin
Baseline, week 30, and years 1 and 2 from start of treatment
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible patients with IIEF at baseline and corresponding time points.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00931528
outcome key
om-0003
source section id
NCT00931528-om-0003
source outcome index
3
endpoint
Overall Patient Sexual Satisfaction as Measured by Change From Baseline in the Sexual Adjustment Questionnaire (SAQ) Score
endpoint definition
The Sexual Adjustment Questionnaire (SAQ) is a 20-item questionnaire with an overall score range between 8 and 100 including the following domains: desire, ranging between 5 and 30; dysfunction, 0 and 25; activity, 0 and 10; satisfaction, 1 and 10; and fatigue, 1 and 5. The change in SAQ score is calculated by subtracting the baseline score from the follow-up score. A positive change indicates an improvement in sexual well-being.
time origin
Baseline, week 30 and years 1 and 2 after the start of treatment
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible patients with data at baseline and corresponding time point
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00931528
outcome key
om-0004
source section id
NCT00931528-om-0004
source outcome index
4
endpoint
Overall Partner Sexual Satisfaction as Measured by Change From Baseline in the Sexual Adjustment Questionnaire-Partner (SAQ-P) Score
endpoint definition
The SAQ-P is an 18-item questionnaire with an overall score range between 0 and 90 including the following domains: desire, dysfunction, activity, satisfaction, and fatigue. The change in SAQ score is calculated by subtracting the baseline score from the follow-up score. A positive change indicates an improvement in sexual well-being.
time origin
Baseline, week 30 and years 1 and 2 after the start of treatment
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Consenting partners of randomized eligible patients with data at baseline and corresponding time point
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00931528
outcome key
om-0005
source section id
NCT00931528-om-0005
source outcome index
5
endpoint
Patient Marital Adjustment as Measured by the Locke's Marital Adjustment Test
endpoint definition
The Locke Marital Adjustment Test (LMAT) is a 16-item questionnaire with scores ranging from 48 to 138 for participants. Higher scores indicate greater sexual function, sexual wellbeing, or marital adjustment. The change in LMAT score is calculated by subtracting the baseline score from the follow-up score.
time origin
Baseline, week 30 and years 1 and 2 after the start of treatment
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible patients with data at baseline and time point of interest.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00931528
outcome key
om-0000
arm key
OG000
arm label
Tadalafil
regimen
Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil once daily for 24 weeks.
analyzed count
80
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00931528-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00931528
outcome key
om-0000
arm key
OG001
arm label
Placebo
regimen
Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
analyzed count
61
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00931528-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00931528
outcome key
om-0001
arm key
OG000
arm label
Tadalafil
regimen
Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil once daily for 24 weeks.
analyzed count
109
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00931528-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00931528
outcome key
om-0001
arm key
OG001
arm label
Placebo
regimen
Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
analyzed count
108
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00931528-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00931528
outcome key
om-0002
arm key
OG000
arm label
Tadalafil
regimen
Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.
analyzed count
109
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00931528-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00931528
outcome key
om-0002
arm key
OG001
arm label
Placebo
regimen
Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
analyzed count
108
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00931528-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00931528
outcome key
om-0003
arm key
OG000
arm label
Tadalafil
regimen
Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil once daily for 24 weeks.
analyzed count
63
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00931528-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00931528
outcome key
om-0003
arm key
OG001
arm label
Placebo
regimen
Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
analyzed count
51
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00931528-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00931528
outcome key
om-0004
arm key
OG000
arm label
Tadalafil
regimen
Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil once daily for 24 weeks.
analyzed count
42
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00931528-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00931528
outcome key
om-0004
arm key
OG001
arm label
Placebo
regimen
Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
analyzed count
40
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00931528-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00931528
outcome key
om-0005
arm key
OG000
arm label
Tadalafil
regimen
Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.
analyzed count
61
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00931528-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00931528
outcome key
om-0005
arm key
OG001
arm label
Placebo
regimen
Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
analyzed count
60
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00931528-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00931528
harm key
EG000
source section id
NCT00931528-ae
event group key
EG000
event group label
Tadalafil
serious affected
3
serious at risk
111
other affected
85
other at risk
111
frequency threshold
5
collection period
Source null
event definition
Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00931528
harm key
EG001
source section id
NCT00931528-ae
event group key
EG001
event group label
Placebo
serious affected
4
serious at risk
108
other affected
76
other at risk
108
frequency threshold
5
collection period
Source null
event definition
Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00931528
qol key
qol-0000
source section id
NCT00931528-om-0000
source outcome index
0
instrument
Patient-reported symptom or function measure
instrument basis
matched 'patient-reported' in the study's own wording
scale title
Percentage of Patients Maintaining Spontaneous (Off-drug) Erectile Function (EF) at Weeks 28-30 After Initiation of Radiation Therapy (RT)
measure definition
EF is measured by Question 1 of the International Index of Erectile Function (IIEF). The IIEF is a validated 15-item for measuring patient-reported erectile function. Question 1 asks "How often were you able to get an erection during sexual activity?" Responses ranged from 0=no sexual activity, to 5=Almost always or always. Higher scores indicated better functioning. All patients have erectile function prior to initiation of RT, indicated by a score of 3, 4, or 5 on IIEF Q1. Patients with a lower IIEF Q1 score at weeks 28-30 than at baseline will have less erectile function and be categorized as nonresponders. Patients with similar or improved erectile function will be categorized as responders (maintaining). Patient-related predictors of at erectile function at this time point are also reported with this outcome measure.
time frame
Baseline and 30 weeks from the start of radiation therapy
analysis role
primary
reporting status
POSTED
higher is better
1
direction quote
Higher scores indicated better
population note
All randomized eligible patients with IIEF at both baseline and 30 week time point.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00931528
qol key
qol-0001
source section id
NCT00931528-om-0001
source outcome index
1
instrument
Patient-reported symptom or function measure
instrument basis
matched 'patient-reported' in the study's own wording
scale title
Percentage of Patients Maintaining Spontaneous (Off-drug) EF at Years 1 and 2 After Initiation of RT
measure definition
The International Index of Erectile Function (IIEF) is a validated 15-item for measuring patient-reported erectile function. Question 1 asks "How often were you able to get an erection during sexual activity?" Responses ranged from 0=no sexual activity, to 5=Almost always or always. Higher scores indicated better functioning. All patients have erectile function prior to initiation of RT, indicated by a score of 3, 4, or 5. Patients with a lower IIEF Q1 score at weeks 28-30 than at baseline will have less erectile function and be categorized as nonresponders. Patients with similar or improved erectile function will be categorized as responders (maintaining). Patient-related predictors of at erectile function at Years 1 and 2 are also reported with this outcome measure.
time frame
Baseline, 1 and 2 years from the start of tadalafil or placebo
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
Higher scores indicated better
population note
All randomized eligible patients with IIEF at both baseline and corresponding time point.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00931528
qol key
qol-0002
source section id
NCT00931528-om-0002
source outcome index
2
instrument
Patient-reported symptom or function measure
instrument basis
matched 'patient-reported' in the study's own wording
scale title
Overall Sexual Function as Measured by Change From Baseline in the International Index of Erectile Function (IIEF)
measure definition
The IIEF is a validated 15-item for measuring patient-reported erectile function. A score of 0-5 is given to each of the 15 questions that examine 5 main domains of male sexual function: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Domain scores are the sum of each item. The erectile function domain has 5 items with a score range of 1-30, orgasmic function has 2 items with a score range of 0-10, sexual desire has 2 items with a score range of 0-10, intercourse satisfaction has 3 items with a score range of 0-15, and overall satisfaction has 2 items with a score range of 2-10. Total score ranges from 0-70, with higher scores indicated better functioning. Change from baseline is calculated by subtracting baseline score from score at the time point of interest.
time frame
Baseline, week 30, and years 1 and 2 from start of treatment
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher scores indicated better
population note
Eligible patients with IIEF at baseline and corresponding time points.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00931528
qol key
qol-0007
source section id
NCT00931528-om-0007
source outcome index
7
instrument
FACT
instrument basis
matched 'factors' in the study's own wording
scale title
Radiotherapy Factors Associated With Spontaneous (Off-drug) EF at Weeks 28-30 and Years 1 and 2 After Initiation of RT
measure definition
Source null
time frame
Baseline, week 30 and years 1 and 2 after the start of treatment
analysis role
exploratory
reporting status
NOT_POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

setting source links

Preserved source evidence · Not medical advice