Prospective Evaluation Of Hypofractionated Stereotactic Body Radiotherapy For Low And Intermediate Risk Prostate Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Adam Olson
- Enrollment
- 163
- Locations
- 1
- Primary Endpoint
- Biochemical Disease-Free Survival Rate (bDFS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
SBRT
Intervention: Stereotactic Body Radiation Therapy (Radiation)
Outcomes
Primary Outcomes
Biochemical Disease-Free Survival Rate (bDFS)
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- 5-year Overall Survival (OS)(At 5 years)
- Rate of Local Failure(Up to 5 years)
- Rate of Distant Failure(Up to 5 years)
- Quality of Life (QoL) - FACT-G - Prior to Therapy(Prior to start of therapy)
- Quality of Life (QoL) - FACT-G - At 24 Months(At 24 months (post-start of therapy))
Investigators
Adam Olson
Clinical Assistant Professor
University of Pittsburgh