Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer

Overview

RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This phase I/II trial is studying the side effects and best dose of stereotactic body radiation therapy and to see how well it works in treating patients with prostate cancer.

Full Title of Study: “A Phase I and II Study of Stereotactic Body Radiation Therapy (SBRT) for Low and Intermediate Risk Prostate Cancer (SBRT Prostate)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 20, 2014

Detailed Description

OBJECTIVES: Primary – To escalate the dose of stereotactic body radiotherapy (SBRT) to a tumoricidal dose without exceeding the maximum tolerated dose in patients with organ-confined prostate cancer. (Phase I) – To determine the late, severe grade 3-5 genitourinary and gastrointestinal toxicity occurring between 270-540 days (i.e., 9-18 months) from the start of the protocol treatment as assessed by CTCAE v3.0. (Phase II) Secondary – To determine the dose-limiting toxicity of SBRT in these patients. (Phase I) – To determine the 2-year biochemical (PSA) control (freedom from PSA failure), disease-free and overall survival, local control, freedom from distant metastases, and the incidence of high-grade adverse events of any type in patients treated with this therapy in order to determine if the therapy is promising enough for further clinical investigation. (Phase II) OUTLINE: This is a multicenter, phase I dose-escalation study followed by a phase II open-label study. – Phase I: Patients undergo 5 treatments of stereotactic body radiotherapy (SBRT). – Phase II: Patients undergo SBRT at the maximum tolerated dose as in phase I. After completion of study treatment, patients are followed at 1.5, 3, 6, 9, and 12 months, every 6 months for 5 years, and then once a year for years 5-10. PROJECTED ACCRUAL: A total of 97 patients will be accrued for this study.

Interventions

  • Radiation: stereotactic body radiation therapy (SBRT)- 45 Gy
    • Dose of SBRT – 45 Gray (Gy) in five fractions
  • Radiation: stereotactic body radiation therapy (SBRT) – 47.5 Gy
    • Dose of SBRT – 47.5 Gray (Gy) in five fractions
  • Radiation: stereotactic body radiation therapy (SBRT) – 50 Gy (Phase 1)
  • Radiation: stereotactic body radiation therapy (SBRT) – 50 Gy (Phase 2)

Arms, Groups and Cohorts

  • Experimental: Phase 1: Stereotactic Body Radiation Therapy (SBRT) 45 Gy
    • The Phase 1 portion of the study will have a 3+3 design. The dose of SBRT is escalated – 45 Gy
  • Experimental: Phase 1: Stereotactic Body Radiation Therapy (SBRT)- 47.5 Gy
    • The Phase 1 portion of the study will have a 3+3 design. The dose of SBRT is escalated- 47.5 Gy
  • Experimental: Phase 1: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy
    • The Phase 1 portion of the study will have a 3+3 design. The dose of SBRT is escalated- 50 Gy
  • Experimental: Phase 2: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy
    • The dose of SBRT is escalated – 50 Gy in Phase 2

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants With Dose Limiting Toxicity (Phase 1 Only)
    • Time Frame: 90 days after start of treatment
    • Dose-limiting toxicity (DLT) was defined as grade 3 to 5 GI, genito urinary, sexual, or neurologic toxicity attributed to therapy occurring within 90 days of registration using Common Terminology Criteria of Adverse Events(version 3)
  • No. of Late Severe GU Toxicity (for Phase 2 Only)
    • Time Frame: 18 months
    • To determine late severe GU toxicity defined as grade 3-5 occurring between 279-540 days (i.e., 9-18 months) from the start of protocol treatment. Toxicity was defined using the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0. CTCAE uses a range of grades from 1 to 5; 1 – Mild 2 – Moderate 3 – Severe 4 – Life-threatening 5 – Death.
  • No. of Late Severe GI Toxicity (for Phase 2 Only)
    • Time Frame: 18 months
    • To determine late severe GI toxicity defined as grade 3-5 occurring between 279-540 days (i.e., 9-18 months) from the start of protocol treatment. Toxicity was defined using the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0. CTCAE uses a range of grades from 1 to 5; 1 – Mild 2 – Moderate 3 – Severe 4 – Life-threatening 5 – Death.

Secondary Measures

  • GU Toxicity (Only Phase 2)
    • Time Frame: 9 months from start of treatment
    • To determine acute severe GU toxicity is defined as grade 3-5 occurring prior to 270 days from the start of the protocol treatment. Toxicity was defined using the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0. CTCAE uses a range of grades from 1 to 5; 1 – Mild 2 – Moderate 3 – Severe 4 – Life-threatening 5 – Death.
  • GI Toxicity
    • Time Frame: 9 months from start of treatment
    • To determine acute severe GI toxicity is defined as grade 3-5 occurring prior to 270 days from the start of the protocol treatment. Toxicity was defined using the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0. CTCAE uses a range of grades from 1 to 5; 1 – Mild 2 – Moderate 3 – Severe 4 – Life-threatening 5 – Death.
  • Non-GU Toxicity
    • Time Frame: 60 months
    • To determine non-GU (genitourinary) toxicity is defined as grade 3-5. Toxicity was defined using the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0. CTCAE uses a range of grades from 1 to 5; 1 – Mild 2 – Moderate 3 – Severe 4 – Life-threatening 5 – Death.
  • Non-GI Toxicity
    • Time Frame: 60 months
    • To determine non-GI (gastrointestinal) toxicity is defined as grade 3-5. Toxicity was defined using the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0. CTCAE uses a range of grades from 1 to 5; 1 – Mild 2 – Moderate 3 – Severe 4 – Life-threatening 5 – Death.
  • Freedom From Biochemical Failure
    • Time Frame: 36 months
    • Biochemical failure RTOG (Radiation Therapy Oncology Group)-ASTRO (American Society for Therapeutic Radiology and Oncology) definition (also known as Phoenix definition). Thus, when the PSA rises by more than 2 ng/ml above the lowest level (nadir) achieved after treatment, biochemical failure has occurred and the date of the failure is recorded at the time the nadir plus 2 ng/ml level is reached.
  • Overall Survival
    • Time Frame: 60 months
    • The survival time will be measured from the date of accession to the date of death.
  • Disease Specific Survival
    • Time Frame: 60 months
    • Disease-Specific Survival Disease-specific survival will be measured from the date of study entry to the date of death due to prostate cancer as the percentage of participants who survived the prostrate cancer disease.
  • Clinical Progression Including Local/Regional and Distant Relapse
    • Time Frame: 60 months
    • Clinical progression including local/regional and distant relapse is measured using Kaplan-Meier method

Participating in This Clinical Trial

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate – Stage T1a, T1b, T1c disease – Stage T2a or T2b – No direct evidence of regional or distant metastases – No T2c, T3, or T4 tumors – Gleason score ≤ 7 – Must meet the following criteria: – Prostate-specific antigen (PSA) ≤ 20 ng/mL prior to starting hormonal therapy (if given) for patients with a Gleason score of 2-6 – PSA ≤ 15 ng/mL prior to starting hormonal therapy (if given) for patients with a Gleason score of 7 – Risk of pelvic lymph node involvement < 20% according to Roach formula – Ultrasound-based volume estimation of the prostate gland ≤ 60 g PATIENT CHARACTERISTICS: – Zubrod performance status 0-2 – Fertile patients must use effective contraception – No prior invasive malignancy, except for nonmelanoma skin cancer, unless disease-free for a minimum of 3 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix are allowed) – No significant urinary obstructive symptoms – American Urological Association (AUA) score of ≤ 15 (alpha blockers allowed) – No history of inflammatory colitis (including Crohn disease and ulcerative colitis) – No history of significant psychiatric illness – No severe, active comorbidity including any of the following: – Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months – Transmural myocardial infarction within the past 6 months – Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration – Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration – Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects – Laboratory tests for liver function and coagulation parameters are not required for entry into this protocol – AIDS (based on current CDC definition) or other immunocompromising condition – HIV testing is not required for entry into this protocol PRIOR CONCURRENT THERAPY: – See Disease Characteristics – More than 9 months since prior hormonal therapy as neoadjuvant therapy or to downsize the prostate gland – No prior pelvic radiotherapy – No prior chemotherapy or surgery for prostate cancer – No prior transurethral resection of the prostate (TURP) or cryotherapy to the prostate – No plans for other concurrent post-treatment, adjuvant, antineoplastic therapy including surgery, cryotherapy, conventionally fractionated radiotherapy, hormonal therapy, or chemotherapy as part of the treatment for prostate cancer

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 120 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Texas Southwestern Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Robert Timmerman, Professor of Medicine – University of Texas Southwestern Medical Center
  • Overall Official(s)
    • Robert D. Timmerman, MD, Study Chair, Simmons Cancer Center

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