Glivec in Prostate Cancer Patients With Rising PSA Following Radical Prostectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Urogenital Neoplasms; Genital Neoplasms, Male; Prostatic Diseases; Antineoplastic Agents; Imatinib; Prostatic Neoplasm; Genital Diseases, Male; Neoplasms, Abdominal
• Intervention / Treatment: Drug: STI571 (Glivec®)

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany
    • Novartis Investigative Site
  • Berlin, Germany
    • Novarts Investigative Site
  • Bonn, Germany
    • Novartis Investigative Site
  • Borken, Germany
    • Novartis Investigative Site
  • Darmstadt, Germany
    • Novartis Investigative Site
  • Fürth, Germany
    • Novartis Investigative Site
  • Gardelegen, Germany
    • Novartis Investigative Site
  • Hamburg, Germany
    • Novarts Investigative Site
  • Köln, Germany
    • Novartis Investigative Site
  • Marburg, Germany
    • Novartis Investigative Site
  • Ulm, Germany
    • Novartis Investigative Site
  • Wesel, Germany
    • Novartis Investigative Site
  • Wuppertal, Germany
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: imatinib mesylate	Drug: STI571 (Glivec®); Other Names: Glivec

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	2 - 4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: June 1, 2003
• Primary Completion (ACTUAL): July 1, 2010

Study Registration Dates

• First Submitted: March 14, 2011
• First Submitted That Met QC Criteria: March 15, 2011
• First Posted (ESTIMATE): March 16, 2011

Study Record Updates

• Last Update Posted (ACTUAL): June 1, 2017
• Last Update Submitted That Met QC Criteria: May 31, 2017
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Prostate cancer,; radical prostatectomy,; PSA rise
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Prostatic Neoplasms; Abdominal Neoplasms; Urogenital Neoplasms; Prostatic Diseases; Genital Neoplasms, Male; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Imatinib Mesylate
• Other Study ID Numbers: CSTI571BDE15