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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


N/A
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Quality of Life

Outcome Description:

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.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Stanley Liauw, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago

Authority:

United States: Institutional Review Board

Study ID:

10-625-A

NCT ID:

NCT01342367

Start Date:

December 2010

Completion Date:

April 2019

Related Keywords:

  • Prostate Cancer
  • Prostate cancer
  • Quality of Life
  • Prostatic Neoplasms

Name

Location

University of ChicagoChicago, Illinois  60637