Evaluation of Circulating Tumors Cells (CTCs) as Potential Surrogate Marker for Further Definition und Subclassification of non metastatic High-Risk Castration Resistant Prostate Cancer Patients
- Conditions
- prostate cancerC61Malignant neoplasm of prostate
- Registration Number
- DRKS00008554
- Lead Sponsor
- OnkoDataMed GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- Male
- Target Recruitment
- 5
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
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.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - To investigate the CTCs in terms of number of patients involved (Rate of patients with any detected CTCs)<br>- CTC counts per patient<br><br>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 Outcome Measures
Name Time Method Secondary Outcome is to describe the results stratified by other prognostic factors such as the risk of metastasis based on PSA doubling time.