An open-label, one arm, multi-centre Phase II trial evaluating the efficacy and safety of DTS-201 as a second-line chemotherapy in patients with hormone refractory prostate cancer

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 40

Inclusion Criteria

1. Male patients =18 years.
2. Performance status Karnofsy = 70%.
3. Life expectancy > 3 months.
4. Histologically documented adenocarcinoma of the prostate.
5. Patient with one prior line of chemotherapy only.
6. Patients should have documented progression of disease.
Disease progression should meet at least one of the following criteria:
a. Prostate spectific antigen (PSA) evidence of progressive prostate cancer during or within 60 days of cessation of first-line chemotherapy consists of a PSA level = 5 ng/ml that has risen on = successive occasions = 2 weeks apart.
b. Progression of measurable disease as defined by response evaluation creiteria in solid tumours (RECIST) (confer Appendix 3 of the protocol).
c. Progression of bone disease characterized by appearance of one or more new bone lesions.
7. Adequate castration (testosterone levels = 50 ng/dL) by orchiectomy or by luteinising-hormone releasing hormone (LHRH agonist).
8. Patients receiving bisphosphate therapy must be on stable doses with stable symptoms prior to enrolment.
9. Adequate hematological and biological functions:
• Bone marrow function:
Neutrophils = 1500/mm3, hemoglobin = 10g/dl, platelets = 100 000/mm3.
• Hepatic function:
Bilirubin < 1.5 upper limit of normal (ULN).
Alkaline phosphatase (AP) = 1.5 ULN, (or AP = 5 ULN for patients with bone metastasis).
Aspartate aminotransferase/alanine aminotransferase (AST/ALT) = 1.5 ULN (or AST/ALT = 3 ULN for patients with liver metastasis).
• Renal function: normal with creatinine clearance = 60 ml/min.
10. Normal cardiac function at clinical examination and left ventricular ejection fraction(LVEF) = 50% (according to multiple gated acquisition scan [MUGA] scan or echography). No history of myocardial infarction within last 12 months.
11. Signed informed consent obtained prior to initiation of any study-specific procedures and treatment.
12. Able to adhere to the study visit schedule and other protocol requirements.
13. To be affiliated to or benefit from a social security system if applicable.

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

1. Previous treatment with an anthracycline or mithoxantrone.
2. Radiotherapy or radioisotope therapy within 4 weeks prior to study drug treatment.
3. Anticancer therapy (chemotherapy, hormone therapy, immunotherapy or biological therapy response modifiers) within 4 weeks prior to study drug first dosing.
4. Steroid therapy within 4 weeks prior to study drug first dosing.
5. Multivitamins, Vitamin D, Calcitrol, and other alternative and food supplement must be discontinued before study registration.
6. Symptomatic brain metastasis per leptomenigeal metastasis or evidence of cord spinal compression.
7. Prior radiotherapy to more than 30% of the bone marrow.
8. Uncontrolled hypercalcemia.
9. History of other malignancies within 5 years at screening, except for adequately treated basal or squamous cell skin cancer.
10. Presence of any serious concomitant systemic disorders incompatible with the study (e.g. active infection).
11. Known positive status for human immunodeficiency virus (HIV) and/or active Hepatitis B or C.
12. Less than 4 weeks after participation to another trial.
13. Any other reason suspected by the investigator as incompatible with study participation.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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