Trial document




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  DRKS00008554

Trial Description

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Title

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

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Trial Acronym

NIS Pro-CTC

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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 system CellSearch(R) System. That system was especially developed for such purposes. The evidence of tumors cells in the blood is an indication for metastasized cancer. In the non-interventional study Pro-CTC it should be investigated, whether this is a method to monitor the success of a therapy in the future. New methods should not only improve the therapy monitoring but should also contribute to the choice of a suitable therapy. The presence of tumors cells in the bloodstream is medically very important for the description of the disease. The evidence of tumors cells in the blood is an indication of a possible cancer spreading.Through this increased knowledge therapeutical measures can be adjusted. Conclusions may be drawn from the number of tumors cells to the severity of the disease.

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Brief Summary in Scientific Language

Objectives: To investigate the CTCs in terms of number of patients involved, and CTC counts per patient.

Indication - Patient Population: Castration resistant Prostate cancer patients with a
• PSA level > 8,0 ng/ml as evaluated no longer than 3 months before study inclusion and
• PSA doubling time < 10 months with at least 2 consecutive measurements of PSA within 6 months before study inclusion, first and last measurements at > 8 weeks interval.

Statistical issues: At first stage 30 patients will be enrolled. In case of promising results a further 30 patients will be included, leading to a total of 60 patients.
Due to the exploratory nature of this study, statistical analysis consists of applying descriptive methods. Primarily, the target parameters will be analysed in all study patients as well as stratified by the following two risk groups:
1. PSA doubling time > 4 und < 10 months (moderate risk)
2. PSA doubling time < 4 months (high risk)
Furthermore, correlations between the target parameters and other prognostic factors such as the gleason score will be investigated.

Measurements of circulating tumour cells: The CellSearch® System (Veridex) is approved by the FDA and allows measuring/capturing tumor cells from the blood of patients with epithelial tumors. CellSave Preservative Tubes ® are used for the collection of the fragile CTCs to improve the reproducibility and reliability of analysis. These tubes contain a cell preservative that stabilizes CTCs up to 96 hours at room temperature, which facilitates sample batching and shipping to remote sites. When the blood samples arrive in the laboratory the CellTracks® AutoPrep® System enables automated sample processing using immunomagnetic cell capture, enrichment, and fluorescence staining (EpCAM, CK, CD45, DAPI). The further analysis is done using the CellTracks Analyzer II®, which is a semi-automated system based on fluorescence optics (microscopy) used to count and characterize CTCs, that have been immunomagnetically selected.

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Organizational Data

  •   DRKS00008554
  •   2015/06/19
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  •   no
  •   Approved
  •   EA4/039/15, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   prostate cancer
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   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 system CellSearch(R) System. That system was especially developed for such purposes. The evidence of tumors cells in the blood is an indication for metastasized cancer. In the non-interventional study Pro-CTC it should be investigated, whether this is a method to monitor the success of a therapy in the future. New methods should not only improve the therapy monitoring but should also contribute to the choice of a suitable therapy. The presence of tumors cells in the bloodstream is medically very important for the description of the disease. The evidence of tumors cells in the blood is an indication of a possible cancer spreading.Through this increased knowledge therapeutical measures can be adjusted. Conclusions may be drawn from the number of tumors cells to the severity of the disease.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

- 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.

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Secondary Outcome

Secondary Outcome is to describe the results stratified by other prognostic factors such as the risk of metastasis based on PSA doubling time.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2015/05/20
  •   60
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional 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

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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.

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Addresses

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    • OnkoDataMed GmbH
    • 15366  Neuenhagen bei Berlin
    • Germany
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    • OnkoDataMed GmbH
    • Ms.  Anne-Katrin  Ullner 
    • Friedenstraße 58
    • 15366  Neuenhagen bei Berlin
    • Germany
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    • OnkoDataMed GmbH
    • Ms.  Anne-Katrin  Ullner 
    • Friedenstraße 58
    • 15366  Neuenhagen bei Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Amgen GmbH
    • 80971  München
    • Germany
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Status

  •   Recruiting stopped after recruiting started
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.