Study of Dasatinib, Androgen Deprivation Therapy and Radiation

• Status: Withdrawn
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

Radiation and androgen deprivation is a common modality for patients with localized prostate cancer. Unfortunately for patients with intermediate to high risk prostate cancer incomplete tumor eradication and subsequent relapse occurs in 50-75% of patients. The Src pathway appears to be integral to the pathobiology of prostate cancer and may be fundamental to radioresistance.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr Anthony Mega
• Treatments: Androgens; Dasatinib

Criteria

PATIENT ELIGIBILITY

-Conditions for Patient Eligibility

Each patient must meet all of the following inclusion criteria to be enrolled in the study:

• Histologically or pathologically confirmed adenocarcinoma of the prostate to be treated with radiation therapy and hormone therapy.

• Intermediate, high or very high risk disease

• Intermediate-risk disease (clinical T2b or T2c stage or PSA 10 to 20 ng/mL or Gleason score 7)

• High-risk disease (Gleason score 8 to 10, serum PSA > 20 ng/mL or T3a disease)

• Very high-risk disease (T3b or T4)

• No prior pelvic or prostate radiation or chemotherapy for prostate cancer.

• Clinically negative lymph nodes as established by imaging (pelvic CT or pelvic MR), nodal sampling or dissection within 8 weeks prior to registration. Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are < 1.5 cm.

• Bone scan within 12 weeks prior to registration. Equivocal bone scan findings are allowed if plain films are negative for metastasis.

• ECOG performance status 0-1

• Age > 18

• Required entry laboratory parameters within 14 days of study entry: Granulocytes ≥ 1500/µl; platelet count ≥ 100,000/µl; Hgb > 8.0 g/dl; Creatinine < 1.5 x the institutional ULN, mg/dl; Bilirubin ≤ 2x institutional upper limit of normal; AST ≤ 2.5 x upper limit of normal, Serum Na+, K+, Mg2+, Phosphate and Calcium within institutional normal range; PT and PTT < 1.5 ULN

• Life expectancy of at least 1 year

• No concurrent anticancer therapy.

• Peripheral neuropathy must be ≤ Grade 2

• A male subject of fathering potential must use an adequate method of contraception throughout the study [and for at least 4 weeks after the last dose of study drug].

• Ability to take oral medication (dasatinib must be swallowed whole)

• Signed study-specific consent form prior to study entry

Conditions for Patient Ineligibility

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

• Evidence of distant metastases (M1).

• Prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any reason

• PSA > 150

• Pathologically positive lymph nodes or nodes > 1.5 cm on imaging

• Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.

• Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable.

• Prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation therapy fields

• Medical History and Concurrent Diseases

• No malignancy [other than the one treated in this study] which required radiotherapy or systemic treatment within the past 5 years.

• Concurrent medical condition which may increase the risk of toxicity, including:

• Pleural or pericardial effusion of any grade

• Cardiac Symptoms; any of the following should be considered for exclusion:

• History of significant bleeding disorder unrelated to cancer, including:

• No history of pulmonary hypertension