Hypofractionated SBRT For Prostate Cancer

Not Applicable

Completed

Conditions: Prostate Cancer

Interventions: Radiation: Stereotactic Body Radiation Therapy

Registration Number: NCT00977860

Lead Sponsor: Adam Olson

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 163

Inclusion Criteria

Histologically proven prostate adenocarcinoma
Gleason score 2-7
Biopsy within one year of date of registration
Clinical stage T1b-T2b, N0-Nx, M0-Mx (AJCC 6th Edition)
T-stage and N-stage determined by physical exam and available imaging studies (ultrasound, CT, and/or MRI)
M-stage determined by physical exam, CT or MRI. Bone scan not required unless clinical findings suggest possible osseous metastases.
PSA ≤ 20 ng/dL
Patients belonging in one of the following risk groups:
Low: CS T1b-T2a and Gleason 2-6 and PSA ≤ 10, or
Intermediate: CS T2b and Gleason 2-6 and PSA ≤ 10, or CS T1b-T2b, and Gleason 2-6 and PSA ≤ 20 ng/dL, or Gleason 7 and PSA ≤ 10 ng/dL
Prostate volume: ≤ 100 cc
Determined using: volume = π/6 x length x height x width
Measurement from CT or ultrasound ≤90 days prior to registration.
ECOG performance status 0-1
Completion of patient questionnaires:FACT-G questionnaire, AUA questionnaire, EPIC-26 questionnaire, SHIM questionnaire, Utilization of Sexual Medications/Devices questionnaire
Consent signed.

Exclusion Criteria

Prior prostatectomy or cryotherapy of the prostate
Prior radiotherapy to the prostate or lower pelvis
Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
Chemotherapy for a malignancy in the last 5 years.
History of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years.
Hormone ablation for two months prior to enrollment, or during treat

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SBRT	Stereotactic Body Radiation Therapy	-

Primary Outcome Measures

Name	Time	Method
Biochemical Disease-Free Survival Rate (bDFS)	Up to 5 years	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.
Rate of Acute Grade 3 or Higher GI and GU Toxicities	Up to 90 days	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.
Rate of Late Grade 3 or Higher GI and GU Toxicities	After 90 days post-treatment, up to 5 years per patient	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.

Secondary Outcome Measures

Name	Time	Method
5-year Overall Survival (OS)	At 5 years	Percentage of patients that remained alive 5 years after start of study treatment. Deaths were from any cause.
Rate of Local Failure	Up to 5 years	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.
Rate of Distant Failure	Up to 5 years	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).
Quality of Life (QoL) - FACT-G - Prior to Therapy	Prior to start of therapy	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.
Quality of Life (QoL) - FACT-G - At 24 Months	At 24 months (post-start of therapy)	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.