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Hypofractionated SBRT For Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stereotactic Body Radiation Therapy
Sponsored by
Adam Olson
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate, Stereotactic, Radiosurgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • UPMC Hillman Cancer Center - Shadyside Radiation Oncology

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

SBRT

Arm Description

Outcomes

Primary Outcome Measures

Rate of acute grade 3 or higher GI and GU toxicities
Proportion 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
Proportion 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 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.

Secondary Outcome Measures

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.
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).
Overall Survival (OS)
Median number of years that patients remain alive after study treatment until death from any cause.
Quality of life (QoL) - FACT-G
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.

Full Information

First Posted
September 15, 2009
Last Updated
July 25, 2023
Sponsor
Adam Olson
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1. Study Identification

Unique Protocol Identification Number
NCT00977860
Brief Title
Hypofractionated SBRT For Prostate Cancer
Official Title
Prospective Evaluation Of Hypofractionated Stereotactic Body Radiotherapy For Low And Intermediate Risk Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 7, 2010 (Actual)
Primary Completion Date
July 8, 2022 (Actual)
Study Completion Date
July 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Adam Olson

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate, Stereotactic, Radiosurgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
163 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SBRT
Arm Type
Other
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation Therapy
Other Intervention Name(s)
CyberKnife, Trilogy, True Beam, Radiosurgery
Intervention Description
36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period
Primary Outcome Measure Information:
Title
Rate of acute grade 3 or higher GI and GU toxicities
Description
Proportion 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.
Time Frame
Up to 5 years
Title
Rate of late grade 3 or higher GI and GU toxicities
Description
Proportion 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.
Time Frame
Up to 5 years
Title
Biochemical Disease-Free Survival Rate (bDFS)
Description
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.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Rate of local failure
Description
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.
Time Frame
Up to 5 years
Title
Rate of distant failure
Description
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).
Time Frame
Up to 5 years
Title
Overall Survival (OS)
Description
Median number of years that patients remain alive after study treatment until death from any cause.
Time Frame
Up to 5 years
Title
Quality of life (QoL) - FACT-G
Description
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.
Time Frame
Up to 5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Olson, MD
Organizational Affiliation
University of Pittsburgh Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Hillman Cancer Center - Shadyside Radiation Oncology
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Hypofractionated SBRT For Prostate Cancer

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