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 @ 10:10 PM
Ignite Modification Date:
2025-12-24 @ 10:10 PM
NCT ID:
NCT00115635
Eligibility Criteria:
Inclusion Criteria:
* Histologically verified adenocarcinoma of the prostate.
* Hormone refractory prostate cancer (HRPC) defined as progression during previous anti-hormone treatment. Patients must have been off previous anti-androgen therapy for more than 4 weeks.
* Stage IV disease (verified by imaging or clinical examination).
* PSA \> 10 microgram/l.
* PSA progression defined as a \> 25% increase between two independent measurements performed with a 1-month interval or more after discontinuation of anti-androgen treatment.
* Castrate level of testosterone (\< 50 ng).
* No previous oestrogen or steroid as metastatic prostate cancer treatment.
* Satisfactory hepatic function in the form of total bilirubin ≤ UNL (upper normal limit), ASAT/ALAT ≤ 2.5 x UNL, alkaline phosphatase ≤ 5 x UNL.
* Satisfactory renal function, defined as serum creatinine ≤ 1.5 x UNL.
* Satisfactory haematologic function defined as ANC \>1.5 x 10\^9/l, leucocytes \>3.0 x 10\^9/l, thrombocytes ≥ 100 x 10\^9/l, haemoglobin \> 7 mmol/l
* ECOG performance status ≤ 2.
* Life expectancy \> 3 months.
* Patient must be able to adhere to protocol requirements.
* Written informed consent.
* \> 18 years of age.
Exclusion Criteria:
* Previous prostate cancer treatment with oestrogens or steroid hormones.
* Previous chemotherapy.
* Previous treatment with systemic radioactive isotopes.
* Bisphosphonate treatment (concomitant).
* Radiation therapy covering more than 25% of the bone marrow producing area.
* Other serious coincidental and/or concomitant medical condition.
* Symptomatic cerebral metastases.
* Other previous or current malignant disease, excluding \*adequately treated and cured planocellular skin carcinoma; or \*other cancer assessed to carry minimal risk of recurrence.
* ECOG performance status \> 2.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
95 Years
Study:
NCT00115635
Study Brief:
Protocol Section:
NCT00115635