Stereotactic Body Radiation Therapy in Treating Patients With Localized High-Risk Prostate Cancer

NCT ID: NCT02296229

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-27
• Study Completion Date: 2027-01-27

Brief Summary

This clinical trial studies stereotactic body radiation therapy in treating patients with high-risk prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. Stereotactic body radiation therapy is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Studying quality of life in patients undergoing stereotactic body radiation therapy may help identify the long-term effects of treatment on patients with prostate cancer.

Detailed Description

PRIMARY OBJECTIVES:

I. To establish the efficacy of stereotactic body radiation therapy (SBRT) in patients with high-risk localized prostate cancer compared to historical data from clinical trials.

II. To establish the safety with physician-reported outcomes after SBRT in patients with high risk localized prostate cancer.

III. To establish the quality of life with patient-reported validated questionnaires after SBRT in patients with high risk localized prostate cancer.

OUTLINE:

Patients undergo SBRT daily or every other day for a total of 5 fraction not exceeding 14 consecutive days. Patients may also receive androgen deprivation therapy for up to 9 months at the discretion of the treating physician.

After completion of study treatment, patients are followed up every 4 months for 1 year, every 6 months for 5 years, and then every 12 months thereafter.

Conditions

Adenocarcinoma of the Prostate; Stage III Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (SBRT)

Patients undergo SBRT daily or every other day for a total of 5 fraction not exceeding 14 consecutive days. Patients may also receive androgen deprivation therapy for up to 9 months at the discretion of the treating physician.

Group Type: EXPERIMENTAL

stereotactic body radiation therapy

Intervention Type: RADIATION

Undergo SBRT

quality-of-life assessment

Intervention Type: OTHER

Ancillary studies

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

androgen deprivation therapy

Intervention Type: DRUG

up to 9 months at the discretion of the treating physician

Interventions

stereotactic body radiation therapy

Undergo SBRT

Intervention Type: RADIATION

quality-of-life assessment

Ancillary studies

Intervention Type: OTHER

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

androgen deprivation therapy

up to 9 months at the discretion of the treating physician

Intervention Type: DRUG

Other Intervention Names

SBRT; stereotactic radiation therapy; stereotactic radiotherapy; quality of life assessment; androgen suppression therapy

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed primary non-metastatic adenocarcinoma of the prostate
• Risk-group classification into the D’Amico or National Comprehensive Cancer Network (NCCN) ‘high-risk’ group, as defined by the presence of any one of the following high-risk factors:

• Pre-biopsy prostate-specific antigen (PSA) >= 20
• Biopsy Gleason score 8-10
• Clinical stage T3
• No pelvic nodal metastases (based on computed tomography [CT] or magnetic resonance imaging [MRI] findings)
• No distant metastases, based upon:

• CT scan or MRI of the pelvis within 120 days prior to registration
• Bone scan within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis
• Karnofsky performance status (KPS) >= 70
• Ability to understand, and willingness to sign, the written informed consent
• Patient will have opted for SBRT among definitive treatment choices

Exclusion Criteria

• Patients with any evidence of distant metastases
• Hormonal therapy (luteinizing hormone-releasing hormone [LHRH] agonist or oral anti-androgen) exceeding 4 months prior to registration
• Prior cryosurgery, high intensity focused ultrasound (HIFU) or brachytherapy of the prostate
• Prior pelvic radiotherapy
• History of Crohn’s disease or Ulcerative colitis

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amar Kishan

Role: PRINCIPAL_INVESTIGATOR

Jonsson Comprehensive Cancer Center

Locations

Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

NCI-2014-02183

Identifier Type: REGISTRY

Identifier Source: secondary_id

JCCCID410

Identifier Type: OTHER

Identifier Source: secondary_id

13-001427

Identifier Type: OTHER

Identifier Source: secondary_id

13-001427

Identifier Type: -

Identifier Source: org_study_id