Trial Outcomes & Findings for Intensity-Modulated Radiation Therapy With or Without Decreased Radiation Dose to Erectile Tissue in Treating Patients With Stage II Prostate Cancer (NCT NCT00084552)
NCT ID: NCT00084552
Last Updated: 2021-02-25
Results Overview
Postage Stamp Test -A row of stamps is placed around the base of the penis and the ends are moistened and joined. If the circle is broken in the morning then the subject was recorded as having had a nocturnal erection International Index of Erectile Function (IIEF) Questionnaire * 15-item questionnaire that measures erectile function * Includes companion questionnaire which measures how the partner feels her sexual relationship with the patient has changed since his cancer diagnosis and therapy
COMPLETED
NA
116 participants
5 year duration after completion of radiotherapy
2021-02-25
Participant Flow
Participant milestones
| Measure |
Standard IMRT (S-IMRT)
Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.
radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.
|
Erectile Tissue Sparing IMRT (ETS-IMRT)
Patients undergo IMRT with dose restriction to erectile tissue once daily 5 days a week for approximately 7.5 weeks.
radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
62
|
|
Overall Study
COMPLETED
|
54
|
62
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intensity-Modulated Radiation Therapy With or Without Decreased Radiation Dose to Erectile Tissue in Treating Patients With Stage II Prostate Cancer
Baseline characteristics by cohort
| Measure |
s-IMRT
n=54 Participants
Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.
radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.
|
ETS-IMRT
n=62 Participants
Patients undergo IMRT with dose restriction to erectile tissue once daily 5 days a week for approximately 7.5 weeks.
radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.
|
Total
n=116 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
62 years
n=7 Participants
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
44 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=5 Participants
|
62 participants
n=7 Participants
|
116 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 year duration after completion of radiotherapyPopulation: Some patients did not submit follow-up questionnaires at 24 months post-treatment
Postage Stamp Test -A row of stamps is placed around the base of the penis and the ends are moistened and joined. If the circle is broken in the morning then the subject was recorded as having had a nocturnal erection International Index of Erectile Function (IIEF) Questionnaire * 15-item questionnaire that measures erectile function * Includes companion questionnaire which measures how the partner feels her sexual relationship with the patient has changed since his cancer diagnosis and therapy
Outcome measures
| Measure |
s-IMRT
n=37 Participants
Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.
radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.
|
ETS-IMRT
n=48 Participants
Patients undergo IMRT with dose restriction to erectile tissue once daily 5 days a week for approximately 7.5 weeks.
radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.
|
|---|---|---|
|
Erectile Dysfunction Rates
|
27 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: 2 years after treatmentPatients without documented failure will undergo needle biopsy of the prostate. A minimum of 12 core biopsies will be taken and additional biopsies will be taken from any suspicious areas (ultrasound or palpation) and/or the original site of biopsy confirmation of prostate cancer at diagnosis. The 12 biopsy sites include sextant, bilateral lateral base, bilateral lateral mid-gland and bilateral transition zone. These data will enable us to evaluate the extent of disease eradication, as well as the prognostic significance of positive biopsies in otherwise palpably normal prostate glands after treatment.
Outcome measures
| Measure |
s-IMRT
n=54 Participants
Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.
radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.
|
ETS-IMRT
n=62 Participants
Patients undergo IMRT with dose restriction to erectile tissue once daily 5 days a week for approximately 7.5 weeks.
radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.
|
|---|---|---|
|
Percentage of Patients With Freedom From Biochemical Failure
|
90.7 percentage of participants
|
91.8 percentage of participants
|
SECONDARY outcome
Timeframe: 5 years after treatmentOutcome measures
| Measure |
s-IMRT
n=54 Participants
Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.
radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.
|
ETS-IMRT
n=62 Participants
Patients undergo IMRT with dose restriction to erectile tissue once daily 5 days a week for approximately 7.5 weeks.
radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.
|
|---|---|---|
|
Acute GI Toxicity
|
1 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 5 years after treatmentOutcome measures
| Measure |
s-IMRT
n=54 Participants
Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.
radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.
|
ETS-IMRT
n=62 Participants
Patients undergo IMRT with dose restriction to erectile tissue once daily 5 days a week for approximately 7.5 weeks.
radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.
|
|---|---|---|
|
Acute GU Toxicity
|
20 Participants
|
27 Participants
|
Adverse Events
s-IMRT
ETS-IMRT
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place