Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2025-12-24 @ 2:46 PM
NCT ID:
NCT00057759
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Prior treatment on RTOG-9910 for intermediate relapse-risk stage II or III prostate cancer as determined by any of the following combinations of factors:
* T1b-4, Gleason score 2-6, and prostate-specific antigen (PSA) greater than 10 ng/mL but no greater than 100 ng/mL
* T1b-4, Gleason score 7, and PSA less than 20 ng/mL
* T1b-1c, Gleason score 8-10, and PSA less than 20 ng/mL
* Radiotherapy completed within the past 6 months to 5 years
* Pretreatment (before enrollment on this study) erectile dysfunction as measured by International Index of Erectile Function Question #1
* Erectile dysfunction before starting prostate cancer therapy allowed
* Patients without partners or without partners willing to participate allowed
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Zubrod 0-2
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Cardiovascular
* No myocardial infarction within the past year
Other
* No other invasive cancer within the past 5 years except localized basal cell or squamous cell skin cancer (stage 0-II)
* No anatomical genital abnormalities or concurrent conditions that would prohibit sexual intercourse or preclude study participation
* No other major medical or psychiatric illness that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* More than 6 months since prior androgen suppression (e.g., leuprolide or goserelin), antiandrogen (e.g., bicalutamide, flutamide, or nilutamide), or estrogenic (e.g., diethylstilbestrol) agents
Radiotherapy
* See Disease Characteristics
Surgery
* No prior penile implant
* No prior bilateral orchiectomy
Other
* No concurrent sildenafil
* No concurrent participation in another medical research study to treat prostate cancer
* No concurrent organic nitrate or requirement for nitrates (e.g., nitroglycerin as needed)
* No concurrent ketoconazole, itraconazole, or erythromycin
* No concurrent use of mechanical (vacuum) devices or intracorporeal, intraurethral, topical, or oral agents for erectile dysfunction
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00057759
Study Brief:
Protocol Section:
NCT00057759