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

Adenocarcinoma of the Prostate Clinical Trial

Official title:

Study of Stereotactic Body Radiotherapy (SBRT) for High-Risk Localized Prostrate Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02296229
• Other study ID #: 13-001427
• Secondary ID: NCI-2014-02183JC
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 27, 2014
• Est. completion date: January 27, 2026

Study information

• Verified date: January 2024
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 220
• Est. completion date: January 27, 2026
• Est. primary completion date: January 27, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma of the Prostate
• Prostatic Neoplasms
• Stage III Prostate Cancer

Intervention

Radiation:
• stereotactic body radiation therapy
Undergo SBRT

Other:
• quality-of-life assessment
Ancillary studies
• laboratory biomarker analysis
Correlative studies

Drug:
• androgen deprivation therapy
up to 9 months at the discretion of the treating physician

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical progression free survival	Biochemical progression is defined as rising PSA profile of > 2 ng/mL above post-SBRT nadir.	At 3 years
Primary	Biochemical progression free survival	Biochemical progression is defined as rising PSA profile of > 2 ng/mL above post-SBRT nadir.	At 5 years
Primary	Incidence of patient-reported genitourinary (GU) and gastrointestinal (GI) toxicity based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4		At 4 months
Primary	Incidence of patient-reported GU and GI toxicity based on the CTCAE version 4		Up to 5 years
Primary	Changes in health related quality of life based on Expanded Prostate Cancer Index Composite questionnaire		Baseline to up to 5 years