DRKS00008554
Active, not recruiting
Not Applicable
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 - NIS Pro-CTC
OnkoDataMed GmbH0 sites5 target enrollmentJune 19, 2015
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- prostate cancer
- Sponsor
- OnkoDataMed GmbH
- Enrollment
- 5
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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.
Outcomes
Primary Outcomes
Not specified
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