Clinical trial NCT00547339: Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer
Official title: A Phase I and II Study of Stereotactic Body Radiation Therapy (SBRT) for Low and Intermediate Risk Prostate Cancer (SBRT Prostate)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2007-10-22
Enrollment: 94
Sex: MALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Dose Limiting Toxicity (Phase 1 Only)
timeFrame: 90 days after start of treatment
measure: No. of Late Severe GU Toxicity (for Phase 2 Only)
timeFrame: 18 months
measure: No. of Late Severe GI Toxicity (for Phase 2 Only)
timeFrame: 18 months
Secondary outcomes:
measure: GU Toxicity (Only Phase 2)
timeFrame: 9 months from start of treatment
measure: GI Toxicity
timeFrame: 9 months from start of treatment
measure: Non-GU Toxicity
timeFrame: 60 months
measure: Non-GI Toxicity
timeFrame: 60 months
measure: Freedom From Biochemical Failure
timeFrame: 36 months
measure: Overall Survival
timeFrame: 60 months
measure: Disease Specific Survival
timeFrame: 60 months
measure: Clinical Progression Including Local/Regional and Distant Relapse
timeFrame: 60 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Cancer Center at UC Health Sciences Center
state: Colorado
city: Orlando
country: United States
facility: MD Anderson Cancer Center Orlando Florida
state: Florida
city: Minneapolis
country: United States
facility: University of Minnesota Cancer Center at University of Minnesota
state: Minnesota
city: Watertown
country: United States
facility: Prairie Lakes Cancer Center
state: South Dakota
city: Dallas
country: United States
facility: Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
state: Texas
Study officials:
affiliation: Simmons Cancer Center
name: Robert D. Timmerman, MD
role: STUDY_CHAIR
References: