Clinical trial NCT01737151: Stereotactic Body Radiation Therapy in Treating Patients With Low- and Intermediate-Risk Prostate Cancer
Official title: Study of 4-Fraction Split-Course Stereotactic Ablative Radiation Therapy of the Treatment of Patients With Low and Intermediate Risk Adenocarcinoma of the Prostate
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Adenocarcinoma
Stage I Prostate Cancer
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2012-11-29
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Late toxicity greater than or equal to grade 2 as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria
timeFrame: 2 years
Secondary outcomes:
measure: Biochemical failure as defined by the Phoenix definition
timeFrame: Up to 5 years
measure: Protocol completion rate
timeFrame: Up to 5 years
measure: Patient-reported outcomes
timeFrame: Up to 5 years
measure: Acute toxicity greater than or equal to grade 2 as defined by the CTCAE version 4 criteria
timeFrame: Up to 90 days
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University/Massey Cancer Center
state: Virginia
Study officials:
affiliation: Massey Cancer Center
name: Timothy J Harris, M.D.
role: PRINCIPAL_INVESTIGATOR
References: