Study of Dasatinib, Androgen Deprivation Therapy and Radiation (BrUOGPR255)
Primary Purpose
Prostate Cancer
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Dasatinib
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dasatinib
Arm Description
Three dasatinib dose levels will be evaluated, 50 mg/day, 70 mg/day and 100 mg/day. Dasatinib will begin with day #1 of radiation and will be discontinued once radiation is completed.
Outcomes
Primary Outcome Measures
Maximum tolerated dose of dasatinib with concurrent standard radiation and hormone therapy
Maximum tolerated dose of dasatinib with concurrent standard radiation and hormone
Secondary Outcome Measures
Time to progression for patients
Time to progression for patients
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01826838
Brief Title
Study of Dasatinib, Androgen Deprivation Therapy and Radiation
Acronym
BrUOGPR255
Official Title
A Phase I Study of Dasatinib, Androgen Deprivation Therapy and Radiation For Intermediate and High Risk Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of patients
Study Start Date
January 2013 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brown University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
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 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.
The primary objective of this trial will be to establish the safety of dasatinib with androgen deprivation and radiation for prostate cancer. Three dasatinib dose levels will be evaluated, 50 mg/day, 70 mg/day and 100 mg/day. Dasatinib will begin with day #1 of radiation and will be discontinued once radiation is completed. The study treatment period, therefore, will be when patients receive concurrent dasatinib, hormone therapy and radiation to 30 days after the last radiation/dasatinib treatment. However, it will be highly recommended that, prior to entering the study, patients receive 2 months of androgen deprivation with a LHRH agonist. Furthermore, it will be highly recommended that, after completion of dasatinib /hormone therapy/radiation, patients with intermediate risk disease receive approximately 2 additional months of hormone therapy (to complete 6 months of hormone therapy) and patients with high risk disease receive 20 additional months of ADT to complete 2 years of hormone therapy. If casodex was given at onset of diagnosis, patient must be off drug for 6 weeks prior to beginning radiation therapy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dasatinib
Arm Type
Experimental
Arm Description
Three dasatinib dose levels will be evaluated, 50 mg/day, 70 mg/day and 100 mg/day. Dasatinib will begin with day #1 of radiation and will be discontinued once radiation is completed.
Intervention Type
Drug
Intervention Name(s)
Dasatinib
Intervention Description
1.1 Primary Objective 1.1.1 To evaluate the maximum tolerated dose and dose limiting toxicities of dasatinib, up to a dose of 100mg/day, with concurrent standard radiation and hormone therapy for patients with intermediate and high risk prostate cancer.
1.2 Secondary Objective: 1.2.1 To determine the time to progression and overall survival for patients who are diagnosed with Intermediate and High Risk Prostate Cancer and were treated with dasatinib.
Primary Outcome Measure Information:
Title
Maximum tolerated dose of dasatinib with concurrent standard radiation and hormone therapy
Description
Maximum tolerated dose of dasatinib with concurrent standard radiation and hormone
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Time to progression for patients
Description
Time to progression for patients
Time Frame
12 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
anthony mega
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Study of Dasatinib, Androgen Deprivation Therapy and Radiation
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