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 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT00002651
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed adenocarcinoma of the prostate
* Metastatic stage IV (stage D2)
* Any number of bone metastases by bone scan allowed
* Unequivocal visceral organ metastases (liver, brain, or lung) allowed
* No suspected second primary tumors unless metastases are histologically confirmed, including special stains (e.g., prostate specific antigen \[PSA\] and prostatic alkaline phosphatase \[PAP\])
* For entry into late induction therapy:
* No more than 1 month from the beginning of antiandrogen therapy to the beginning of luteinizing hormone-releasing hormone (LHRH) agonist therapy
* No more than 6 months since initiation of current combined androgen-deprivation therapy (LHRH agonist and antiandrogen)
* The effectiveness of the current depot LHRH agonist would not extend beyond 8 months after initiation of combined androgen therapy
* PSA at least 5 ng/mL
* No acute spinal cord compression
PATIENT CHARACTERISTICS:
Age:
* Adult
Performance status:
* SWOG 0-2
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* Recovered from any major infection
* No active medical illness that would preclude study or limit survival
* No other malignancy within the past 5 years except:
* Adequately treated basal cell or squamous cell skin cancer
* Adequately treated carcinoma in situ of the bladder
* Adequately treated other superficial cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent biological response modifier therapy
Chemotherapy:
* No concurrent chemotherapy
Endocrine therapy:
* See Disease Characteristics
* More than 1 year since any prior neoadjuvant or adjuvant hormonal therapy for a duration of no more than 4 months
* Single or combination therapy allowed
* More than 1 year since prior finasteride for prostate cancer for a duration of no more than 9 months (less than 6 months for benign prostatic hypertrophy)
* Prior or concurrent megestrol for hot flashes allowed
* No other concurrent hormonal therapy
Radiotherapy:
* No concurrent radiotherapy other than palliation of painful bone metastases
Surgery:
* No prior bilateral orchiectomy
* Recovered from any prior major surgery
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00002651
Study Brief:
Protocol Section:
NCT00002651