prostate cancer C61
Conditions
Interventions
Group 1: Within the scope of this non-interventional study circulating tumors cells (CTCs) will be obtained by taking a blood sample, which will be characterized and counted by using the analysis syst
Sponsors
OnkoDataMed GmbH
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Men with histologically confirmed prostate cancer 2. Age = 18 years 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 4. Chemical or surgical castration defined as: • bilateral orchiectomy (also referred to as orchidectomy) at least 6 months before CTC measurement, OR • continuous androgen deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) agonist or antagonist for at least 6 months before CTC measurement 5. Total serum testosterone level of < 50 ng/dL (1.72 nmol/L) 6. Castration resistant prostate cancer demonstrated during continuous ADT/post-orchiectomy defined as: • 3 consecutive PSA values with PSA1 < PSA2 < PSA3 • each PSA value must be separated by at least 2 weeks • PSA2 and PSA3 = 1.0 ng/mL 7. High risk for development of bone metastasis and detection of CTCs defined as: • Gleason score 3+4 or higher and • PSA value = 8.0 ng/mL, obtained no more than 3 months before inclusion and • PSA doubling time = 10 months 8. Before any study-specific procedure, the appropriate written informed consent must be obtained 9. Adequate organ function, as defined by the following criteria: • Serum aspartate aminotransferase (AST) = 2.5 x upper limit of normal (ULN) • Serum alanine aminotransferase (ALT) = 2.5 x ULN • Serum total bilirubin = 1.5 x ULN • Serum calcium or albumin-adjusted serum calcium = 2.0 mmol/L (8.0 mg/dL) and = 2.9 mmol/L (11.5 mg/dL) 10. Routine blood draw which permits the number of circulating tumor cells (CTC) to be measured by the CellSearch® System of Veridex 11. Before any study-specific procedure, the appropriate written informed consent must be obtained
Exclusion criteria
Exclusion criteria: 1. Prior or current evidence of radiographically detectable bone metastasis as evidenced by bone scan not elder than 6 weeks relative to the time of CTC measurement 2. Known prior or current evidence of any metastatic involvement of distant organs (lymph node metastases in any region is acceptable) 3. Prior or current i.v. bisphosphonate administration 4. To exclude any influence of prior bone therapy on occult tumor cells: Prior or current use of oral bisphosphonates as follows: • greater than or equal to 3 years continuously • greater than 3 months but less than 3 years (eligible if subject has a 1 year washout before study entry) 5. To exclude any influence of prior bone therapy on occult tumor cells: Prior administration of denosumab • greater than or equal to 3 years continuously • greater than 3 months but less than 3 years (eligible if subject has a 1 year washout) 6. Three months or less since receiving a non-bone related investigational product or device in a clinical trial. 7. 12 months or less since receiving a bone related investigational product or device in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - To investigate the CTCs in terms of number of patients involved (Rate of patients with any detected CTCs) - CTC counts per patient The primary objective of this study is to determine the rate of patients with any circulating tumour cells and the total number of CTCs in patients under routine treatment of non-metastatic castration resistant prostate cancer. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcome is to describe the results stratified by other prognostic factors such as the risk of metastasis based on PSA doubling time. | — |
Countries
Germany
Contacts
Public ContactAnne-Katrin Ullner
OnkoDataMed GmbH
Outcome results
None listed