Prostate CancerNCT01342367
Feasibility of Hormones and Radiation for Intermediate or High Risk Prostate Cancer
A study testing Bicalutamide, Dutasteride and Finasteride in people with Prostate Cancer, run by University of Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Bicalutamide, Dutasteride and Finasteride
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2010to Feb 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Prostate Cancer
- Being tested
- Bicalutamide, Dutasteride, Finasteride, Radiation
- Keywords
- Prostate cancer, Quality of Life
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BicalutamideDrug
Also called Casodex
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.
DutasterideDrug
Also called Avodart, Jalyn
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.
FinasterideDrug
Also called Propecia, Proscar
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.
RadiationRadiation
7-8 weeks of radiation with bicalutamide and either dutasteride or finasteride.
| Study group | Role | What they receive |
|---|---|---|
| Oral Androgen Therapy | Experimental | Subjects will receive two oral hormonal drugs (bicalutamide with dutasteride or bicalutamide with finasteride) Receives: Drug: Bicalutamide; Drug: Dutasteride; Drug: Finasteride; Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 months, and 24 months
Secondary outcomes (1)
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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2011 (estimated)
- Study start17 Dec 2010
- Primary completion1 May 2020
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stanley Liauw, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01342367
- Sponsor's protocol ID
- 10-625-A
- Status last verified
- Jun 2025
- First submitted
- 15 Apr 2011
- Last updated
- 10 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01342367
- Acronym / sponsor ID
- 10-625-A
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Quality of Life
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 17 Dec 2010 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- Feb 2026 (estimated)
- First posted
- 27 Apr 2011 (estimated)
- Results
- Posted 28 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral Androgen Therapy | Experimental | Drug: Bicalutamide, Drug: Dutasteride, Drug: Finasteride, Radiation: RadiationSubjects will receive two oral hormonal drugs (bicalutamide with dutasteride or bicalutamide with finasteride) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BicalutamideAlso: CasodexBicalutamide 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. | Drug | Oral Androgen Therapy |
| DutasterideAlso: Avodart, JalynDutasteride 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. | Drug | Oral Androgen Therapy |
| FinasterideAlso: Propecia, ProscarFinasteride 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. | Drug | Oral Androgen Therapy |
| Radiation7-8 weeks of radiation with bicalutamide and either dutasteride or finasteride. | Radiation | Oral Androgen Therapy |
Primary outcome
Quality of Life Was Measured by the Expanded Prostate Cancer Index Composite (EPIC) Hormonal Health-related Quality of Life Questionnaire
Time frame: Baseline, 6 months, and 24 months
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.
1 secondary outcome
Percentage of Participants Free From Biochemical Failure
Time frame: 4 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stanley Liauw, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bicalutamide, Dutasteride and Finasteride in people with Prostate Cancer, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Was Measured by the Expanded Prostate Cancer Index Composite (EPIC) Hormonal Health-related Quality of Life Questionnaire (time frame: Baseline, 6 months, and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.