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

Jonsson Comprehensive Cancer Center

Status: Active, not recruiting

Conditions: Adenocarcinoma of the Prostate; Stage III Prostate Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02296229

NCI-2014-02183 (Registry Identifier)

JCCCID410 (Other Identifier)

13-001427 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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220 participants in 1 patient group

Treatment (SBRT)

Experimental group

Description:

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.

Treatment:

Other: quality-of-life assessment

Other: laboratory biomarker analysis

Radiation: stereotactic body radiation therapy

Drug: androgen deprivation therapy