Glivec in Prostate Cancer Patients With Rising PSA Following Radical Prostectomy

Novartis

Status and phase

Completed

Phase 2

Conditions

Imatinib

Antineoplastic Agents

Urogenital Neoplasms

Genital Neoplasms, Male

Prostatic Neoplasm

Neoplasms, Abdominal

Prostatic Diseases

Genital Diseases, Male

Treatments

Drug: STI571 (Glivec®)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01316458

CSTI571BDE15

Details and patient eligibility

About

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.

Enrollment

51 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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