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Glivec in Prostate Cancer Patients With Rising PSA Following Radical Prostectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01316458
Recruitment Status : Completed
First Posted : March 16, 2011
Last Update Posted : June 1, 2017
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
To investigate the ability of 600 mg of Glivec®, given once daily by mouth to patients with rising PSA following radical prostatectomy, to produce a sustained biochemical response during the first 6 months of treatment.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasm Genital Neoplasms, Male Neoplasms, Abdominal Urogenital Neoplasms Genital Diseases, Male Prostatic Diseases Antineoplastic Agents Imatinib Drug: STI571 (Glivec®) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multicenter, Phase II Study to Evaluate the Ability of Glivec® (Imatinib, Formerly Known as STI571) to Produce a Biochemical Response in Patients With Rising PSA Following Radical Prostatectomy
Study Start Date : June 2003
Actual Primary Completion Date : July 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: imatinib mesylate Drug: STI571 (Glivec®)
Other Name: Glivec

Primary Outcome Measures :
  1. investigate the ability of 600 mg of Glivec®, given once daily by mouth to patients with rising PSA following radical prostatectomy, to produce a sustained biochemical response during the first 6 months of treatment. [ Time Frame: 2 - 4 weeks ]

Secondary Outcome Measures :
  1. investigate the time to sustained biochemical response under the treatment of Glivec® in this patient population [ Time Frame: continuous ]
  2. investigate duration of biochemical sustained response under the treatment with Glivec® in this patient population. [ Time Frame: continuous ]
  3. To assess the response rates: number of patients with complete, partial and minor biochemical response and stable PSA [ Time Frame: continuous ]
  4. To assess the time to clinical progression of this patient population treated with Glivec® at this dose and schedule. [ Time Frame: continuous ]
  5. To descriptively characterize the safety and tolerability of Glivec® administered at this dose and schedule to this patient population. [ Time Frame: continuous ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • who are 18 years of age or older.
  • who have undergone radical prostatectomy within 2 years prior to PSA progression .
  • exhibiting two consecutive rises in PSA levels relative to a previous reference value, separated by 14 days.

The first measurement must occur 14 days after the reference value und must be at least 20% above the reference value. The reference value must be at least 0.4 ng/ml. The second confirmatory measurement taken 14 days after the first measurement must be greater than the first measurement.

  • with a Karnofsky Performance Score (KPS) greater than or equal to 90 (Appendix 5).
  • with the following hematologic lab values: ANC greater than or equal to 1500/mm3, Hgb greater than or equal to 10g/dL, PLT greater than or equal to 100x109/L.
  • with the following biochemistry lab values: total bilirubin < 1.5 ULN, SGOT, SGPT less than or equal to 2.5 ULN, serum creatinine less than or equal to 1.5 ULN.
  • willing to employ an effective barrier method of contraception during the study duration and for 3 months following discontinuation of study drug (for patients of reproductive potential).
  • with a life expectancy of > 6 months.
  • who have provided written informed consent pursuant to local regulatory requirements prior to initiation of any study procedure.

with a Gleason Score > 6 in the prostatectomy specimen

Exclusion Criteria:

  • with a history of another malignancy within 5 years prior to study entry, except curatively treated non-melanotic skin cancer, unless written approval is obtained by the sponsor.
  • with prior hormonal therapy
  • who require therapy with warfarin or analgesics of the morphine class or higher (see Section 3.4.4).
  • with a known diagnosis of HIV, hepatitis B, or hepatitis C infection.
  • who have had a major surgery within 2 weeks prior to study entry.
  • with severe, unstable, or uncontrolled medical disease which would confound diagnoses or evaluations required by the protocol, including severe cardiac insufficiency (NYHA III or IV, see Appendix 2), uncontrolled diabetes, chronic hepatic or renal disease, and active uncontrolled infection.
  • with a history of noncompliance to medical regimens or inability or unwillingness to return for all scheduled visits.

Other protocol-defined inclusion/exclusion criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01316458

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Novartis Investigative Site
Aachen, Germany
Novarts Investigative Site
Berlin, Germany
Novartis Investigative Site
Bonn, Germany
Novartis Investigative Site
Borken, Germany
Novartis Investigative Site
Darmstadt, Germany
Novartis Investigative Site
Fürth, Germany
Novartis Investigative Site
Gardelegen, Germany
Novarts Investigative Site
Hamburg, Germany
Novartis Investigative Site
Köln, Germany
Novartis Investigative Site
Marburg, Germany
Novartis Investigative Site
Ulm, Germany
Novartis Investigative Site
Wesel, Germany
Novartis Investigative Site
Wuppertal, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT01316458    
Other Study ID Numbers: CSTI571BDE15
First Posted: March 16, 2011    Key Record Dates
Last Update Posted: June 1, 2017
Last Verified: March 2011
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Prostate cancer,
radical prostatectomy,
PSA rise
Additional relevant MeSH terms:
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Prostatic Neoplasms
Urogenital Neoplasms
Genital Neoplasms, Male
Abdominal Neoplasms
Prostatic Diseases
Genital Diseases, Male
Neoplasms by Site
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action