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

Phase 1/Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

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



- 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)


- 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.

Inclusion Criteria


- 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


- 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

- 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


- 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

- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (MTD) or a dose of 50 Gy total (whichever comes first)

Safety Issue:


Principal Investigator

Robert D. Timmerman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Simmons Cancer Center



Study ID:




Start Date:

July 2006

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • Prostatic Neoplasms



Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390