Study of Dasatinib, Androgen Deprivation Therapy and Radiation

NCT01826838 | Withdrawn Phase 1 DMC

• 1 other identifier: BrUOG 255
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose of dasatinib with concurrent standard radiation and hormone therapy

  Maximum tolerated dose of dasatinib with concurrent standard radiation and hormone

  3 months

Secondary Outcomes (1)

• Time to progression for patients

  12 weeks

Study Arms (1)

Dasatinib

EXPERIMENTAL

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.

Drug: Dasatinib

Interventions

Dasatinib DRUG

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.

Dasatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[and for at least 4 weeks after the last dose of study drug\].

You may not qualify if:

• 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
• History of significant bleeding disorder unrelated to cancer, including:
• No history of pulmonary hypertension

Sponsors & Collaborators

• Brown University: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• anthony mega

  Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2012
• First Posted: April 9, 2013
• Study Start: January 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: February 24, 2022

Record last verified: 2022-02