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

NCT02296229 | Active Not Recruiting

• 3 other identifiers: 13-001427NCI-2014-02183JCCCID410
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenocarcinoma of the Prostate; Stage III Prostate Cancer

Outcome Measures

Primary Outcomes (5)

• Biochemical progression free survival

  Biochemical progression is defined as rising PSA profile of \> 2 ng/mL above post-SBRT nadir.

  At 3 years

• Biochemical progression free survival

  Biochemical progression is defined as rising PSA profile of \> 2 ng/mL above post-SBRT nadir.

  At 5 years

• 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

• Incidence of patient-reported GU and GI toxicity based on the CTCAE version 4

  Up to 5 years

• Changes in health related quality of life based on Expanded Prostate Cancer Index Composite questionnaire

  Baseline to up to 5 years

Study Arms (1)

Treatment (SBRT)

EXPERIMENTAL

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.

Radiation: stereotactic body radiation therapy; Other: quality-of-life assessment; Other: laboratory biomarker analysis; Drug: androgen deprivation therapy

Interventions

stereotactic body radiation therapy RADIATION

Undergo SBRT

Also known as: SBRT, stereotactic radiation therapy, stereotactic radiotherapy

Treatment (SBRT)

quality-of-life assessment OTHER

Ancillary studies

Also known as: quality of life assessment

Treatment (SBRT)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (SBRT)

androgen deprivation therapy DRUG

up to 9 months at the discretion of the treating physician

Also known as: androgen suppression therapy

Treatment (SBRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiosurgery; Androgen Antagonists

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Amar Kishan

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2014
• First Posted: November 20, 2014
• Study Start: January 27, 2014
• Primary Completion: January 27, 2026
• Study Completion (Estimated): January 27, 2027
• Last Updated: February 25, 2026

Record last verified: 2025-02

Locations

US (1)