Feasibility of Hormones and Radiation for Intermediate or High Risk Prostate Cancer

The University of Chicago

Status

Active, not recruiting

Conditions

Prostate Cancer

Treatments

Radiation: Radiation

Drug: Dutasteride

Drug: Finasteride

Drug: Bicalutamide

Study type

Interventional

Funder types

Other

Identifiers

NCT01342367

10-625-A

Details and patient eligibility

About

The purpose of this study is see if quality of life is improved in patients receiving oral hormone therapy compared to standard of care. The study will also compare survival rates between patients receiving oral hormone therapy and those receiving standard of care.

Enrollment

74 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age > or = 70 years and/or Charlson comorbidity index score > or = 2
Pathologically (histologically) proven diagnosis of prostatic adenocarcinoma
Two or more of the following intermediate risk features for recurrence, Gleason Score = 7, PSA 10-20 ng/ml, Clinical Stage T2b-T2c Percent positive biopsy cores > or = 50%
One or more of the following high risk features for recurrence, Gleason Score 8-10, PSA > 20 ng/ml, Clinical Stage T3a-T4
Clinically negative lymph nodes as established by imaging, nodal sampling, or dissection
No evidence of bone metastases on bone scan
History/physical examination via the Charlson Comorbidity Index within 60 days prior to registration
Zubrod Performance Status 0-2
Age > or = 18
Baseline serum PSA within 60 days prior to registration
Baseline serum testosterone obtained within 60 days prior to registration
Study entry PSA and serum testosterone must not be obtained during the following time frames, 10-day period following prostate biopsy, following initiation of oral androgen manipulation, within 30 days after discontinuation of finasteride or dutasteride
CBC/ differential obtained within 60 days prior to registration with adequate bone marrow function
Patient must be able to provide study-specific informed consent prior to study entry
Liver function parameters as follows, Total Bilirubin < or = 2 x institutional upper limit of normal, AST (SGOT) or ALT (SGPT) < or = 2 x institutional upper limit normal

Exclusion criteria

Prior radical surgery (prostatectomy), high-intensity focused ultrasound (HIFU) or cryosurgery for prostate cancer
Prior hormonal therapy, such as LHRH agonists (e.g., goserelin, leuprolide), antiandrogens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or bilateral orchiectomy
Use of 5-alpha reductase inhibitors (finasteride, dutasteride) specifically prescribed for the treatment of prostate cancer
Prior or concurrent cytotoxic chemotherapy for prostate cancer; prior chemotherapy for a different cancer is permitted
Prior radiation, including brachytherapy, to the region of the prostate that would result in overlap of RT fields
Active lupus or scleroderma
Severe, active co-morbidity, including but not limited to,unstable angina within the last 6 months without subsequent corrective cardiovascular procedure,or acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
Hepatic insufficiency with AST, ALT, or Bilirubin > 2 x upper limit of normal,clinical jaundice, and/or coagulation defects
Acquired Immune Deficiency Syndrome (AIDS); note, however, that HIV testing is not required for entry into this protocol.Patients who are HIV seropositive but do not meet criteria for diagnosis of AIDS are eligible for study participation