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Stereotactic Body Radiotherapy (SBRT) With Concurrent Boost for Low- and Intermediate-Risk Prostate Cancer (Prostate SBRT)

Primary Purpose

Prostate Cancer

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Prostate SBRT with concurrent boost to intraprostatic lesion(s)
Sponsored by
Rocky Mountain Cancer Centers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate cancer, Stereotactic body radiotherapy, Radiosurgery, Intensity-modulated radiotherapy, SBRT, IMRT, Early-stage prostate cancer, Low-risk prostate cancer, Intermediate-risk prostate cancer, Intraprostatic lesions, IPL

Eligibility Criteria

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

Inclusion Criteria:

  • Histologically proven diagnosis of prostate adenocarcinoma within one year
  • Gleason Score 2-7
  • Clinical T-stage T1b-T2c (AJCC 7th Edition)
  • Clinical Nx or N0, and Mx or M0
  • PSA < 20 ng/mL
  • Low or intermediate risk according to NCCN guidelines: Low: Clinical Stage (CS) T1b-T2a and Gleason 2-6 and PSA < 10 ng/ml; Intermediate: CS T2b-T2c and Gleason 2-6 and PSA < 10 ng/ml, or CS T1b-T2a and Gleason 7 and PSA < 10 ng/ml, or CS T1b-T2a and Gleason 2-6 and PSA 10-20ng/mL
  • ECOG performance status 0 or 1
  • Has had a pre-treatment PSA drawn within a month of the beginning of protocol therapy
  • If androgen-deprivation therapy (ADT) has been initiated, must have a documented pre-ADT PSA; this baseline PSA should not be obtained during following periods: 1) 10-day period following prostate biopsy; 2) within 30 days after discontinuation of finasteride; or 3) within 90 days after discontinuation of dutasteride.
  • Has completed a baseline health-related quality of life assessment Extended Prostate Cancer Index Composite questionnaire (EPIC-26)
  • Has had a history and physical examination (including digital rectal examination and a formal morbidity assessment via the ACE-27) within 60 days
  • Morbidity score (via the ACE-27) of none (0), mild (1) or moderate (2)
  • Willing and able to use adequate contraception during protocol treatment and for 3 months after the completion of protocol treatment

Exclusion Criteria:

  • Invasive (carcinoma in situ is allowed) solid or hematologic malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years
  • Prior prostatectomy or cryotherapy of the prostate
  • Prior radiotherapy to the prostate or lower pelvis
  • Prior or concurrent cytotoxic chemotherapy for prostate cancer (prior chemotherapy for a different cancer is allowed)
  • Implanted hardware near the planning target volume that would prohibit appropriate treatment planning or treatment delivery in the investigator's opinion

Sites / Locations

  • Rocky Mountain Cancer Centers - Aurora
  • Rocky Mountain Cancer Centers - Littleton

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prostate SBRT

Arm Description

Prostate SBRT with concurrent boost to intraprostatic lesion (IPL) will be delivered in 5 fractions using intensity-modulated radiotherapy planning techniques.

Outcomes

Primary Outcome Measures

Biochemical disease-free survival
Biochemical Disease-Free Survival (bDFS), the time from completion of protocol treatment to the documented PSA rise of 2 ng/mL above the PSA nadir reached after treatment.

Secondary Outcome Measures

Grade 2 or higher acute gastrointestinal, genitourinary, and erectile toxicities
Grade 2 or higher acute gastrointestinal, genitourinary, and erectile toxicities, graded per CTCAE 3.0. Acute adverse events will be recorded as the first occurrence of worst severity of the adverse event ≤ 30 days from completion of protocol radiotherapy.
Grade 3 or higher late gastrointestinal, genitourinary, and erectile toxicities
Grade 3 or higher late gastrointestinal, genitourinary, and erectile toxicities, graded per CTCAE 3.0. Late adverse events are defined as the first occurrence of a late grade 3+ adverse event > 30 days from completion of protocol radiotherapy.
Freedom from failure
Freedom from failure, defined as the time from the first date of radiation to first event of biochemical failure (nadir + 2 ng/mL), local recurrence, regional recurrence, or distant disease as defined below.
Local recurrence-free survival
Local recurrence-free survival, defined as the time from the first date of radiation to first pathologic confirmation of in-prostate tumor recurrence. The local recurrence will be dated when the palpable progression was first identified. In the event of biochemical failure followed by negative metastatic workup and positive biopsy for in-prostate recurrence, the local recurrence will be dated the date of the documented biochemical failure.
Distant disease-free survival
Distant disease-free survival, defined as the time from the first date of radiation to first documentation of metastatic disease by any method, regardless of the occurrence of any intervening local or regional failure or non-prostate second primary cancer. If metastatic diagnosis was prompted by biochemical failure, distant recurrence will be dated the date of biochemical failure.
Cause-specific survival
A death will be deemed a prostate cancer specific death if death is due to prostate cancer or a complication from treatment.
Overall survival
Overall survival, defined as the time from the first date of radiation to death due to any cause.
Health-related quality of life
Health-related quality of life (HRQOL), measured with the Extended Prostate Cancer Index Composite questionnaire - short form (EPIC-26).

Full Information

First Posted
August 3, 2011
Last Updated
February 10, 2014
Sponsor
Rocky Mountain Cancer Centers
Collaborators
Dr. Dennis Carter
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1. Study Identification

Unique Protocol Identification Number
NCT01409473
Brief Title
Stereotactic Body Radiotherapy (SBRT) With Concurrent Boost for Low- and Intermediate-Risk Prostate Cancer
Acronym
Prostate SBRT
Official Title
A Prospective Protocol of Stereotactic Body Irradiation With Concurrent Intraprostatic Lesion Boost Utilizing Intensity Modulated Radiotherapy for Patients With Low- and Intermediate-Risk Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Withdrawn
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rocky Mountain Cancer Centers
Collaborators
Dr. Dennis Carter

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether stereotactic body radiation therapy (SBRT) with simultaneous boost (higher radiation dose) to areas within the prostate with more prominent cancerous growth (intraprostatic lesions) utilizing intensity modulated radiotherapy (IMRT) planning techniques is a safe and effective treatment in patients with low- and intermediate-risk localized prostate cancer.
Detailed Description
Standard external beam radiation therapy (EBRT) for low- to intermediate-risk prostate cancer involves several weeks of daily treatment sessions. Stereotactic body radiation therapy (SBRT) is a newer form of EBRT that gives fewer treatments but higher doses of radiation per treatment. In many patients there are certain areas within the prostate with more prominent cancerous growth (intraprostatic lesions), which may require higher doses of radiation (boost) to treat effectively. This study will treat the prostate with simultaneous boost(s) to intraprostatic lesion(s) in 5 treatments over 10-14 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate cancer, Stereotactic body radiotherapy, Radiosurgery, Intensity-modulated radiotherapy, SBRT, IMRT, Early-stage prostate cancer, Low-risk prostate cancer, Intermediate-risk prostate cancer, Intraprostatic lesions, IPL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prostate SBRT
Arm Type
Experimental
Arm Description
Prostate SBRT with concurrent boost to intraprostatic lesion (IPL) will be delivered in 5 fractions using intensity-modulated radiotherapy planning techniques.
Intervention Type
Radiation
Intervention Name(s)
Prostate SBRT with concurrent boost to intraprostatic lesion(s)
Other Intervention Name(s)
Stereotactic surgery to the prostate
Intervention Description
40 Gy in 5 fractions to prostate for low-risk and 45 Gy in 5 fractions to prostate for intermediate-risk patients, and 50 Gy in 5 fractions to intraprostatic lesion(s), delivered over 10-14 days on preferably every other day.
Primary Outcome Measure Information:
Title
Biochemical disease-free survival
Description
Biochemical Disease-Free Survival (bDFS), the time from completion of protocol treatment to the documented PSA rise of 2 ng/mL above the PSA nadir reached after treatment.
Time Frame
5-8 years
Secondary Outcome Measure Information:
Title
Grade 2 or higher acute gastrointestinal, genitourinary, and erectile toxicities
Description
Grade 2 or higher acute gastrointestinal, genitourinary, and erectile toxicities, graded per CTCAE 3.0. Acute adverse events will be recorded as the first occurrence of worst severity of the adverse event ≤ 30 days from completion of protocol radiotherapy.
Time Frame
30 days from completion of protocol radiotherapy
Title
Grade 3 or higher late gastrointestinal, genitourinary, and erectile toxicities
Description
Grade 3 or higher late gastrointestinal, genitourinary, and erectile toxicities, graded per CTCAE 3.0. Late adverse events are defined as the first occurrence of a late grade 3+ adverse event > 30 days from completion of protocol radiotherapy.
Time Frame
>30 days to 5 years from completion of protocol radiotherapy
Title
Freedom from failure
Description
Freedom from failure, defined as the time from the first date of radiation to first event of biochemical failure (nadir + 2 ng/mL), local recurrence, regional recurrence, or distant disease as defined below.
Time Frame
5-8 years
Title
Local recurrence-free survival
Description
Local recurrence-free survival, defined as the time from the first date of radiation to first pathologic confirmation of in-prostate tumor recurrence. The local recurrence will be dated when the palpable progression was first identified. In the event of biochemical failure followed by negative metastatic workup and positive biopsy for in-prostate recurrence, the local recurrence will be dated the date of the documented biochemical failure.
Time Frame
5-8 years
Title
Distant disease-free survival
Description
Distant disease-free survival, defined as the time from the first date of radiation to first documentation of metastatic disease by any method, regardless of the occurrence of any intervening local or regional failure or non-prostate second primary cancer. If metastatic diagnosis was prompted by biochemical failure, distant recurrence will be dated the date of biochemical failure.
Time Frame
5-8 years
Title
Cause-specific survival
Description
A death will be deemed a prostate cancer specific death if death is due to prostate cancer or a complication from treatment.
Time Frame
5-8 years
Title
Overall survival
Description
Overall survival, defined as the time from the first date of radiation to death due to any cause.
Time Frame
8-10 years
Title
Health-related quality of life
Description
Health-related quality of life (HRQOL), measured with the Extended Prostate Cancer Index Composite questionnaire - short form (EPIC-26).
Time Frame
2-3 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically proven diagnosis of prostate adenocarcinoma within one year Gleason Score 2-7 Clinical T-stage T1b-T2c (AJCC 7th Edition) Clinical Nx or N0, and Mx or M0 PSA < 20 ng/mL Low or intermediate risk according to NCCN guidelines: Low: Clinical Stage (CS) T1b-T2a and Gleason 2-6 and PSA < 10 ng/ml; Intermediate: CS T2b-T2c and Gleason 2-6 and PSA < 10 ng/ml, or CS T1b-T2a and Gleason 7 and PSA < 10 ng/ml, or CS T1b-T2a and Gleason 2-6 and PSA 10-20ng/mL ECOG performance status 0 or 1 Has had a pre-treatment PSA drawn within a month of the beginning of protocol therapy If androgen-deprivation therapy (ADT) has been initiated, must have a documented pre-ADT PSA; this baseline PSA should not be obtained during following periods: 1) 10-day period following prostate biopsy; 2) within 30 days after discontinuation of finasteride; or 3) within 90 days after discontinuation of dutasteride. Has completed a baseline health-related quality of life assessment Extended Prostate Cancer Index Composite questionnaire (EPIC-26) Has had a history and physical examination (including digital rectal examination and a formal morbidity assessment via the ACE-27) within 60 days Morbidity score (via the ACE-27) of none (0), mild (1) or moderate (2) Willing and able to use adequate contraception during protocol treatment and for 3 months after the completion of protocol treatment Exclusion Criteria: Invasive (carcinoma in situ is allowed) solid or hematologic malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years Prior prostatectomy or cryotherapy of the prostate Prior radiotherapy to the prostate or lower pelvis Prior or concurrent cytotoxic chemotherapy for prostate cancer (prior chemotherapy for a different cancer is allowed) Implanted hardware near the planning target volume that would prohibit appropriate treatment planning or treatment delivery in the investigator's opinion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Leonard, MD
Organizational Affiliation
Rocky Mountain Cancer Centers
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rocky Mountain Cancer Centers - Aurora
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Rocky Mountain Cancer Centers - Littleton
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States

12. IPD Sharing Statement

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Stereotactic Body Radiotherapy (SBRT) With Concurrent Boost for Low- and Intermediate-Risk Prostate Cancer

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