Clinical trial NCT01342367: Feasibility of Hormones and Radiation for Intermediate or High Risk Prostate Cancer
Official title: A Feasibility Study of Oral Hormonal Therapy and Radiation for Non-metastatic, Intermediate or High Risk Prostate Cancer in Men 70 and Older or With Medical Comorbidities
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate cancer
Quality of Life
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2011-04-27
Enrollment: 74
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Quality of Life Was Measured by the Expanded Prostate Cancer Index Composite (EPIC) Hormonal Health-related Quality of Life Questionnaire
timeFrame: Baseline, 6 months, and 24 months
Secondary outcomes:
measure: Percentage of Participants Free From Biochemical Failure
timeFrame: 4 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Stanley Liauw, MD
role: PRINCIPAL_INVESTIGATOR
References: