Hypofractionated SBRT For Prostate Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: Stereotactic Body Radiation Therapy

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 Type: Interventional
• Enrollment (Actual): 163
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Hillman Cancer Center - Shadyside Radiation Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: SBRT	Radiation: Stereotactic Body Radiation Therapy; 36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period; Other Names: CyberKnife; Trilogy; True Beam; Radiosurgery

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Adam Olson
• Investigators: Principal Investigator: Adam Olson, MD, University of Pittsburgh Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2010
• Primary Completion (Actual): July 8, 2022
• Study Completion (Actual): July 8, 2022

Study Registration Dates

• First Submitted: September 15, 2009
• First Submitted That Met QC Criteria: September 15, 2009
• First Posted (Estimated): September 16, 2009

Study Record Updates

• Last Update Posted (Estimated): May 2, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Prostate; Stereotactic; Radiosurgery
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: HCC 09-031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes