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

Virginia Commonwealth University (VCU)

Status: Terminated

Conditions: Prostate Adenocarcinoma; Stage I Prostate Cancer

Treatments: Radiation: four fraction split-course SBRT; Radiation: stereotactic body radiation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01737151

MCC-14712

NCI-2012-02545 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

Arm I (standard stereotactic body radiation therapy (SBRT)

Active Comparator group

Description:

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

Treatment:

Radiation: stereotactic body radiation therapy

Arm II (four fraction split-course SBRT)

Experimental group

Description:

Patients undergo 2 fractions of SBRT in weeks 1 and 4

Treatment:

Radiation: four fraction split-course SBRT