Clinical trial NCT02296229: Stereotactic Body Radiation Therapy in Treating Patients With Localized High-Risk Prostate Cancer
Official title: Study of Stereotactic Body Radiotherapy (SBRT) for High-Risk Localized Prostrate Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Adenocarcinoma of the Prostate
Stage III Prostate Cancer
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 220
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed primary non-metastatic adenocarcinoma of the prostate
* Risk-group classification into the Dâ€™Amico or National Comprehensive Cancer Network (NCCN) â€˜high-riskâ€™ 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 Crohnâ€™s disease or Ulcerative colitis

Primary outcomes:
measure: Biochemical progression free survival
timeFrame: At 3 years
measure: Biochemical progression free survival
timeFrame: At 5 years
measure: Incidence of patient-reported genitourinary (GU) and gastrointestinal (GI) toxicity based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4
timeFrame: At 4 months
measure: Incidence of patient-reported GU and GI toxicity based on the CTCAE version 4
timeFrame: Up to 5 years
measure: Changes in health related quality of life based on Expanded Prostate Cancer Index Composite questionnaire
timeFrame: Baseline to up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: Amar Kishan
role: PRINCIPAL_INVESTIGATOR
References: