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 @ 7:06 PM
Ignite Modification Date:
2025-12-24 @ 7:06 PM
NCT ID:
NCT03119857
Eligibility Criteria:
Inclusion Criteria:
* Men \> 18 and ≤80 years of age.
* WHO/ECOG performance status 0 - 1 (WHO: World Health Organization; ECOG: Eastern Cooperative Oncology Group )
* Histological proven adenocarcinoma of the prostate.
* Patients who are planned to receive antiandrogen (bicalutamide 150 mg x 1) treatment,
* After curative treatment
* Prostatectomy: PSA \> 10 OR PSA DT \< 12 months and PSA \> 0.5 (PSA doubling time calculation must start at a minimum value of \> 0.5)
* Radiation: PSA \> +2.0 above nadir and PSA \>10 OR PSA DT \< 12 months and PSA \> 0.5. (PSA bouncing after radiotherapy should be excluded according to the local traditions, and PSA doubling time calculation must start at a minimum value of \> 0.5)
* In locally advanced (or local not suitable for curative therapy) prostate cancer patients, PSA \< 100 is required before inclusion AND one of the following
* PSA DT \< 12 months or
* PSA \>20 or
* Gleason score 8-10
* Previous hormonal therapy in conjunction with radiotherapy is allowed, provided that the total duration of therapy does not exceed 12 months and has to be stopped \> 12 months ago.
* Testosterone value \> 5 nmol/l
* Adequate haematological-, liver- and kidney function. WBC(white blood cell ) 3.5 x 109/L ANC(absolute neutrophil count ) 1.5 x 109/L Platelet Count 150 x 109/L Haemoglobin \> 120 g/L Total bilirubin ≤ ULN (upper limit of normal) unless due to Gilbert's disease Creatinine ≤ 1.5 x ULN or creatinine clearance of 60 cc/min or corresponding Iohexol clearance value ASAT(aspartate aminotransferase )/ALAT(alanine aminotransferase) ≤ 1.5 x ULN ALP (Alkaline phosphatase) \< 1.5 x ULN
* Negative bone scan performed no more than 3 months prior to randomisation.
* Additional CT or ultrasound of thorax, abdomen and/or pelvis is optional.
* Written informed consent.
Exclusion Criteria:
* Positive bone scan
* Any distant metastasis detected by CT or ultrasound
* Patients with a history of previous malignant disease. Exceptions should be made for basal cell carcinoma (BCC) and squamous cell carcinoma of the skin. Exceptions should also be made for curatively treated malignant disease, which has been disease free for the past 5 years.
* Previous chemotherapy or randomised in SPCG 12/AdPro or SPCG 13/AdRad (SPCG: Scandinavian Prostate Cancer Group).
* Systemic corticosteroids within 6 months prior to randomisation.
* Unstable cardiovascular disease, including myocardial infarction, within 6 months prior to randomisation.
* Active untreated infectious disease, including tuberculosis, MRSA (Methicillin-resistant Staphylococcus aureus.
* Active gastric ulcer.
* Known hypersensitivity to Polysorbate 80 (an excipient of docetaxel)
* Other serious illness or medical condition
* Symptomatic peripheral neuropathy ≥ CTCAE grade 2.
* Patients who by altered physical or psychological state not are able to co-operate or participate in the trial.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03119857
Study Brief:
Protocol Section:
NCT03119857