Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period

Stereotactic Body Radiation Therapy

Adam Olson, MD

The purpose of this study is to determine, in both low-risk and intermediate-risk cohorts, the rates of acute and late grade 3 or higher gastrointestinal and genitourinary toxicity observed during a 24 month follow up and to estimate the rate of biochemical Disease-Free Survival, Phoenix and American Society for Therapeutic Radiology and Oncology definitions, at 2 years following hypofractionated stereotactic body radiation therapy for low and intermediate risk prostate cancer.

Radiosurgery should be ideal for treating prostate cancer because:

* targeting accuracy for static targets is excellent, with an error of about 1mm,
* it can adjust for intra-fractional organ motion, reducing the volume of the target PTV and therefore the dose to surrounding organs,
* by using over one-hundred non-conplanar beams, the dose gradient between the prostate and surrounding tissues may be superior to that achieved with conventional linear accelerators,
* the radiobiology of prostate cancer may favor large dose per fractions.

Hypofractionated SBRT For Prostate Cancer

Prospective Evaluation Of Hypofractionated Stereotactic Body Radiotherapy For Low And Intermediate Risk Prostate Cancer

Number of patients experiencing acute grade 3 or higher GI and GU toxicities. Acute toxicities are those occurring within 90 days of start of treatment, assessed using the NCI Common Toxicity Criteria (CTCAE) version 3.0.

Number of patients experiencing late grade 3 or higher GI and GU toxicities. Late toxicities are those occurring after 90 days post start of treatment, assessed using the NCI Common Toxicity Criteria (CTCAE) version 3.0.

Biochemical Disease-Free Survival (bDFS) as defined by Phoenix and ASTRO. Biochemical progression-free survival events were defined as PSA of ≥ 0.4 ng/mL following postoperative radiotherapy, PSA \> 2.0 ng/mL at any time, clinical progression, initiation of non-protocol hormone therapy, and death from any cause.

Proportion of patients with 'local failure', which is defined as clinical evidence local recurrence. Clinical failure includes a palpable abnormality that has increased in size, failure of regression of a palpable abnormality, or redevelopment of a prostate abnormality after complete response, further confirmed by prostate biopsy.

Proportion of patients with 'distant failure' (includes regional failure) which is defined as documented clinically via bone scan, CT or other imaging study that shows metastatic disease (disease located distant from the prostate area).

Percentage of patients that remained alive 5 years after start of study treatment. Deaths were from any cause.

The Functional Assessment of Cancer Therapy- General (FACT-G) is a self-administered 27-item questionnaire designed to measure four domains of HRQOL in cancer patients. It is comprised of physical (PWB), social (SWB), emotional (EWB), and functional (FWB) well-being subscales: (PWB; 7-items, score range 0-28), (SWB; 7-items, score range 0-28), (EWB; 6-items, score range 0-24), (FWB; 7-items, score range 0-28). The FACT-G generates an overall score of 0-108). All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much) and asks information regarding the patients last 7 days.

Adam Olson

Clinical Assistant Professor

Stereotactic Body Radiation Therapy: 36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period

SBRT

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Barbara M Stadterman, MPH, MCCR

Rate of Acute Grade 3 or Higher GI and GU Toxicities

All enrolled patients that received SBRT therapy.

Rate of Late Grade 3 or Higher GI and GU Toxicities

All enrolled patients that received SBRT therapy with PSA assessment.

Biochemical Disease-Free Survival Rate (bDFS)

Rate of Local Failure

Rate of Distant Failure

5-year Overall Survival (OS)

FACTG

Patients that received SBRT therapy, that completed quality of life assessments Prior to therapy.

Spots Global Cancer Trial Database for Hypofractionated SBRT For Prostate Cancer

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