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

Trial Status: Active

This study investigates 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 uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period 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.

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
  • Patient with any evidence of disease beyond the seminal vesicles, including in regional lymph nodes, on standard CT scan, MRI scan, or advanced imaging such as 11C-acetate positron emission tomography (PET)/CT, 68Ga-prostate specific membrane antigen (PSMA) PET/CT, 18Fflucivlovine PET/CT, or 18NaF PET/CT (i.e., no N+ or cM+ patients are eligible)

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Amar Kishan
Phone: 310-825-9775
West Covina
Advanced Oncology Center Inc
Status: APPROVED
Contact: Kevin Lin
Phone: 626-956-8089

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.

IV. To collect germ-line deoxyribonucleic acid (DNA) and nucleic acids from cancer patients to further investigate

the association and identify new germ-line mutations that impact cancer predisposition. (Germ-line substudy primary objective)

V. To investigate the role of germ-line mutations in predicting cancer outcome and response to therapy. (Germ-line substudy primary objective)

SECONDARY OBJECTIVES:

I. To determine the effect of the identified variants on tumor micro ribonucleic acid (miRNA), protein and gene expression. (Germ-line substudy secondary objective)

II. To study expression of DNA, ribonucleic acid (RNA) or protein in the blood of cancer patients with and

without variants of interest to discover correlations between such levels and the presence of cancer and/or

response to therapy in these patients. (Germ-line substudy secondary objective)

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.

Trial Phase Phase NA

Trial Type Observational

Lead Organization
UCLA / Jonsson Comprehensive Cancer Center

Principal Investigator
Amar Kishan

  • Primary ID 13-001427
  • Secondary IDs NCI-2014-02183, JCCCID410
  • Clinicaltrials.gov ID NCT02296229