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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

Phase 2
18 Years
Not Enrolling
Prostatic Neoplasms,, Genital Neoplasms, Male,, Neoplasms,, Urogenital Neoplasms,, Genital Diseases, Male,, Prostatic Diseases,, Antineoplastic Agents,, Imatinib

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Trial Information

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

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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

2 - 4 weeks

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


Germany: Bundesinstitut für Arzneimittel und Medizinprodukte

Study ID:




Start Date:

June 2003

Completion Date:

Related Keywords:

  • Prostatic Neoplasms,
  • Genital Neoplasms, Male,
  • Neoplasms,
  • Urogenital Neoplasms,
  • Genital Diseases, Male,
  • Prostatic Diseases,
  • Antineoplastic Agents,
  • Imatinib
  • Prostate cancer,
  • radical prostatectomy,
  • PSA rise
  • Neoplasms
  • Genital Diseases, Male
  • Genital Neoplasms, Male
  • Prostatic Diseases
  • Prostatic Neoplasms
  • Urogenital Neoplasms