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 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
NCT ID:
NCT01422850
Eligibility Criteria:
Inclusion Criteria:
1. Serum castration levels of testosterone, (total testosterone under 1.7nmol/l).
2. Three consecutive rises of PSA minimum 1 week apart, resulting in at least two 50 % increases over the PSA nadir.
3. Antiandrogen withdrawal for at least 4 weeks, or PSA progression despite secondary hormonal manipulations, or progression of osseous or soft tissue lesions.
4. Be over the age of 18 and capable of understanding the information and giving informed consent.
5. Expected survival time (life expectancy) of over 6 months.
6. Adequate performance status better than 2 (WHO/ECOG Performance status score).
Exclusion Criteria:
1. A low blood count (haemoglobin \< 6.0 mmol/l).
2. Lymphocyte counts below 0.8 x 109/l.
3. Positive tests for anti-HIV-1/2; HBsAg, anti-HBc (Hepatitis B Core Antigen) and Anti-HCV (Hepatitis C Virus).
4. Syphilis i.e. being positive in a Treponema Pallidum test.
5. Uncontrolled serious bacterial, viral, fungal or parasitic infection.
6. Clinically significant autoimmune disorders or conditions of immune suppression.
7. Treatment with corticosteroids (steroid hormones) or bisphosphonates or have been in chemotherapy or radiation treatment one month prior to inclusion in the clinical trial.
8. Blood transfusions within 48 hours prior to donation of blood for ALECSAT production.
9. Inclusion in other clinical trials 6 weeks prior to inclusion in the trial or enrolment in other clinical trials during the ALECSAT clinical trial.
10. Any medical condition that will render participation in the study risky or, according to the Investigator will make the assessment of side effects difficult.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01422850
Study Brief:
Protocol Section:
NCT01422850