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

Primary Purpose

Prostate Cancer

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Bicalutamide

Dutasteride

Finasteride

Radiation

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate cancer, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

University of Chicago

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oral Androgen Therapy

Arm Description

Subjects will receive two oral hormonal drugs (bicalutamide with dutasteride or bicalutamide with finasteride)

Outcomes

Primary Outcome Measures

Quality of Life Was Measured by the Expanded Prostate Cancer Index Composite (EPIC) Hormonal Health-related Quality of Life Questionnaire

Questionnaires were completed in writing by the patient. Questionnaires were administered at 1-2 months after initiation of hormonal treatment (before RT), at 3-4 months (during RT), and at 6 months after initiation of study therapy. Patients also completed questionnaires at 12, 18, and 24 months after completion of radiation therapy. Of primary interest were the baseline and 6 month and 24 month timepoints which are reported here. Scale scores could range from 0-100, with higher scores indicating better quality of life.

Secondary Outcome Measures

Percentage of Participants Free From Biochemical Failure

Increase in prostate-specific antigen (PSA) measured over time. Freedom from biochemical failure (FFBF) was defined from the time of enrollment until PSA failure occurs as defined by the Phoenix definition of a rise to 2 ng/mL above the nadir PSA value.

Full Information

NCT ID

NCT01342367

First Posted

April 15, 2011

Last Updated

May 9, 2023

Sponsor

University of Chicago

1. Study Identification

Unique Protocol Identification Number

NCT01342367

Brief Title

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

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 17, 2010 (Actual)

Primary Completion Date

May 1, 2020 (Actual)

Study Completion Date

February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Chicago

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

Prostate cancer, Quality of Life

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

74 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oral Androgen Therapy

Arm Type

Experimental

Arm Description

Subjects will receive two oral hormonal drugs (bicalutamide with dutasteride or bicalutamide with finasteride)

Intervention Type

Drug

Intervention Name(s)

Bicalutamide

Other Intervention Name(s)

Casodex

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Dutasteride

Other Intervention Name(s)

Avodart, Jalyn

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Finasteride

Other Intervention Name(s)

Propecia, Proscar

Intervention Description

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.

Intervention Type

Radiation

Intervention Name(s)

Radiation

Intervention Description

7-8 weeks of radiation with bicalutamide and either dutasteride or finasteride.

Primary Outcome Measure Information:

Title

Quality of Life Was Measured by the Expanded Prostate Cancer Index Composite (EPIC) Hormonal Health-related Quality of Life Questionnaire

Description

Time Frame

Baseline, 6 months, and 24 months

Secondary Outcome Measure Information:

Title

Percentage of Participants Free From Biochemical Failure

Description

Time Frame

4 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stanley Liauw, MD

Organizational Affiliation

University of Chicago

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

12. IPD Sharing Statement

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

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