Stereotactic Body Radiation Therapy in Treating Patients With Low- and Intermediate-Risk Prostate Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-08

Study Completion Date

2017-11-09

Brief Summary

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This clinical trial studies stereotactic body radiation therapy in treating patients with low- and intermediate-risk prostate cancer. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

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Detailed Description

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PRIMARY OBJECTIVES:

I. To evaluate, in terms of late toxicity, the safety of stereotactic radiation therapy using the proposed fractionation schedule.

SECONDARY OBJECTIVES:

I. To evaluate, in terms of acute toxicity, the safety of stereotactic radiation therapy using the proposed fractionation schedule.

II. To determine stereotactic treatment efficacy through biochemical failure (Phoenix criteria).

III. To determine the protocol completion rate. IV. To describe patient-reported outcomes using International Index of Erectile Function (IIEF) and EPIC Urinary and Bowel Assessment questionnaires.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo standard daily fractions of stereotactic body radiation therapy (SBRT) over 7-8.5 weeks.

Conditions

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Prostate Adenocarcinoma Stage I Prostate Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm I (standard stereotactic body radiation therapy (SBRT)

Patients undergo standard daily fractions of SBRT over 7-8.5 weeks

Group Type ACTIVE_COMPARATOR

stereotactic body radiation therapy

Intervention Type RADIATION

Undergo SBRT

Arm II (four fraction split-course SBRT)

Patients undergo 2 fractions of SBRT in weeks 1 and 4

Group Type EXPERIMENTAL

four fraction split-course SBRT

Intervention Type RADIATION

four fraction split-course SBRT

Interventions

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stereotactic body radiation therapy

Undergo SBRT

Intervention Type RADIATION

four fraction split-course SBRT

Intervention Type RADIATION

Other Intervention Names

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SBRT, stereotactic radiation therapy, stereotactic radiotherapy

Eligibility Criteria

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Inclusion Criteria

* Patients must have low or intermediate risk adenocarcinoma of the prostate as defined by:

* Low-risk disease - Histopathology score (Gleason sum): =\<6, T-stage (per current AJCC staging criteria): T1c-T2a, and PSA: \<10
* Intermediate-risk disease as either:

* Histopathology score (Gleason sum) =\< 6, T-stage (per current American Joint Committee on Cancer \[AJCC\] staging criteria): T1c-T2a, and prostate-specific antigen (PSA) \> 10 but =\< 20; or
* Histopathology score (Gleason sum) 7 with =\< 50% of any cores positive, T-stage (per current AJCC staging criteria): T1c-T2a, and PSA \< 10
* Charlson index of comorbidity score =\< 4
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

* Patients with history of inflammatory bowel disease, or who require steroid or cytotoxic therapy for collagen vascular disease
* Patients with a history of cancer other than skin cancer within 5 years of the initiation of protocol treatment
* Patients with a history of pelvic irradiation for any reason
* Life expectancy \< 10 years - Prior treatment with an anti-androgen, luteinizing hormone-releasing hormone (LHRH) agonist, or a combination of the two
* Prior radiation therapy, brachytherapy, or cryotherapy
* Prior surgical procedure involving peri-rectal and peri-prostatic area

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No