KEES- A single arm phase II trial of the peroral regimen KEES (Ketokonazole, Etoposide, Estramustine, Sendoxan) in patients with Castration Resistant Prostate Cancer (CRPC) - KEES- a phase II study in patients with CRPC

Conditions: Men with castration resistant prostate cancer
MedDRA version: 14.0Level: LLTClassification code 10062904Term: Hormone-refractory prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Registration Number: EUCTR2010-021962-31-SE

Lead Sponsor: Bo Lennernäs

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: 40

Inclusion Criteria

Patients with histological evidence of prostate cancer with verified progressive CRPC.

Patients should have received prior castration hormonal therapy (ablatio, or GnRH agonists) in any form with the addition of antiandrogens and also tried excluding the antiandrogen (antiandrogen withdrawal effect). Ongoing GnRH therapy should continue.

Testosterone should be within castration level.

PSA > 10 ng/ml, and disease progression reflected by PSA increase, with the latest value within 1 month.

WHO performance 0-2.

Life expectancy > 3 months.

Laboratory requirements:
(a) Haematology:
- Neutrophils > 1.5 x 109/L
- Haemoglobin > 10 g/dl.
- Platelets > 100 x 109/L

(b) Hepatic function:
-Total bilirubin < the upper-normal limit of the institution.
-ALAT and ASAT < 2.5 times the upper-normal limit of the institution.

Age < 80 years

Signed informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Prior chemotherapy for CRPC within ???? months

Treatment with steroids within the last ????? months.

Prior study drug (non chemotherapy) within 4 weeks prior to inclusion

Other active malignant disease (except basalioma) within the past 5 years.

Other serious illness or medical condition:
(a) Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry;
(b) Uncontrolled infection
(c) Peptic ulcer on medication, insulin-requiring diabetes mellitus or other contraindications for the use of corticosteroids.
(d) History of thromboembolic disease