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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01342367
Other study ID # 10-625-A
Secondary ID
Status Recruiting
Phase N/A
First received April 15, 2011
Last updated March 22, 2018
Start date December 17, 2010
Est. completion date April 2019

Study information

Verified date March 2018
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date April 2019
Est. primary completion date October 2018
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Bicalutamide
Bicalutamide 50 mg orally daily with either dutasteride or finasteride for 2 months. After two months of treatment bicalutamide with either dutasteride or finasteride will be taken along with radiation. After completion of radiation, bicalutamide will be stopped.
Dutasteride
Dutasteride 0.5 mg orally will be taken daily with bicalutamide for 2 months. After two months of treatment dutasteride and bicalutamide will be taken along with radiation. After completion of radiation, dutasteride will be taken alone for two years.
Finasteride
Finasteride 5 mg orally will be taken daily with bicalutamide for 2 months. After two months of treatment finasteride and bicalutamide will be taken along with radiation. After completion of radiation, finasteride will be taken alone for two years.
Radiation:
Radiation
7-8 weeks of radiation with bicalutamide and either dutasteride or finasteride.

Locations

Country Name City State
United States University of Chicago Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of Life Health-related quality of life will be summarized using a score reflecting patient reported symptoms in sexual, hormone/vitality, fatigue, and overall quality of life. 6 months
Secondary Progression Free Survival Increase in prostate specific antigen (PSA)measured over time. 5 years
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