Status:
WITHDRAWN
Study of Dasatinib, Androgen Deprivation Therapy and Radiation
Lead Sponsor:
Brown University
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief 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 eradicat...
Detailed Description
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 eradicat...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01826838
Start Date
January 1 2013
End Date
April 1 2013
Last Update
February 24 2022
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