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Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
stereotactic body radiation therapy (SBRT)- 45 Gy
stereotactic body radiation therapy (SBRT) - 47.5 Gy
stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 1)
stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2)
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate

    • Stage T1a, T1b, T1c disease
    • Stage T2a or T2b
  • No direct evidence of regional or distant metastases
  • No T2c, T3, or T4 tumors
  • Gleason score ≤ 7

  • Must meet the following criteria:

    • Prostate-specific antigen (PSA) ≤ 20 ng/mL prior to starting hormonal therapy (if given) for patients with a Gleason score of 2-6
    • PSA ≤ 15 ng/mL prior to starting hormonal therapy (if given) for patients with a Gleason score of 7
    • Risk of pelvic lymph node involvement < 20% according to Roach formula
  • Ultrasound-based volume estimation of the prostate gland ≤ 60 g

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-2
  • Fertile patients must use effective contraception
  • No prior invasive malignancy, except for nonmelanoma skin cancer, unless disease-free for a minimum of 3 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix are allowed)

  • No significant urinary obstructive symptoms

    • American Urological Association (AUA) score of ≤ 15 (alpha blockers allowed)
  • No history of inflammatory colitis (including Crohn disease and ulcerative colitis)
  • No history of significant psychiatric illness

  • No severe, active comorbidity including any of the following:

    • Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
    • Transmural myocardial infarction within the past 6 months
    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration

    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

      • Laboratory tests for liver function and coagulation parameters are not required for entry into this protocol

    • AIDS (based on current CDC definition) or other immunocompromising condition

      • HIV testing is not required for entry into this protocol

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 9 months since prior hormonal therapy as neoadjuvant therapy or to downsize the prostate gland
  • No prior pelvic radiotherapy
  • No prior chemotherapy or surgery for prostate cancer
  • No prior transurethral resection of the prostate (TURP) or cryotherapy to the prostate
  • No plans for other concurrent post-treatment, adjuvant, antineoplastic therapy including surgery, cryotherapy, conventionally fractionated radiotherapy, hormonal therapy, or chemotherapy as part of the treatment for prostate cancer

Sites / Locations

  • University of Colorado Cancer Center at UC Health Sciences Center
  • MD Anderson Cancer Center Orlando Florida
  • University of Minnesota Cancer Center at University of Minnesota
  • Prairie Lakes Cancer Center
  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Phase 1: Stereotactic Body Radiation Therapy (SBRT) 45 Gy

Phase 1: Stereotactic Body Radiation Therapy (SBRT)- 47.5 Gy

Phase 1: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy

Phase 2: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy

Arm Description

The Phase 1 portion of the study will have a 3+3 design. The dose of SBRT is escalated - 45 Gy

The Phase 1 portion of the study will have a 3+3 design. The dose of SBRT is escalated- 47.5 Gy

The Phase 1 portion of the study will have a 3+3 design. The dose of SBRT is escalated- 50 Gy

The dose of SBRT is escalated - 50 Gy in Phase 2

Outcomes

Primary Outcome Measures

Number of Participants With Dose Limiting Toxicity (Phase 1 Only)
Dose-limiting toxicity (DLT) was defined as grade 3 to 5 GI, genito urinary, sexual, or neurologic toxicity attributed to therapy occurring within 90 days of registration using Common Terminology Criteria of Adverse Events(version 3)
No. of Late Severe GU Toxicity (for Phase 2 Only)
To determine late severe GU toxicity defined as grade 3-5 occurring between 279-540 days (i.e., 9-18 months) from the start of protocol treatment. Toxicity was defined using the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0. CTCAE uses a range of grades from 1 to 5; 1 - Mild 2 - Moderate 3 - Severe 4 - Life-threatening 5 - Death.
No. of Late Severe GI Toxicity (for Phase 2 Only)
To determine late severe GI toxicity defined as grade 3-5 occurring between 279-540 days (i.e., 9-18 months) from the start of protocol treatment. Toxicity was defined using the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0. CTCAE uses a range of grades from 1 to 5; 1 - Mild 2 - Moderate 3 - Severe 4 - Life-threatening 5 - Death.

Secondary Outcome Measures

GU Toxicity (Only Phase 2)
To determine acute severe GU toxicity is defined as grade 3-5 occurring prior to 270 days from the start of the protocol treatment. Toxicity was defined using the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0. CTCAE uses a range of grades from 1 to 5; 1 - Mild 2 - Moderate 3 - Severe 4 - Life-threatening 5 - Death.
GI Toxicity
To determine acute severe GI toxicity is defined as grade 3-5 occurring prior to 270 days from the start of the protocol treatment. Toxicity was defined using the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0. CTCAE uses a range of grades from 1 to 5; 1 - Mild 2 - Moderate 3 - Severe 4 - Life-threatening 5 - Death.
Non-GU Toxicity
To determine non-GU (genitourinary) toxicity is defined as grade 3-5. Toxicity was defined using the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0. CTCAE uses a range of grades from 1 to 5; 1 - Mild 2 - Moderate 3 - Severe 4 - Life-threatening 5 - Death.
Non-GI Toxicity
To determine non-GI (gastrointestinal) toxicity is defined as grade 3-5. Toxicity was defined using the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0. CTCAE uses a range of grades from 1 to 5; 1 - Mild 2 - Moderate 3 - Severe 4 - Life-threatening 5 - Death.
Freedom From Biochemical Failure
Biochemical failure RTOG (Radiation Therapy Oncology Group)-ASTRO (American Society for Therapeutic Radiology and Oncology) definition (also known as Phoenix definition). Thus, when the PSA rises by more than 2 ng/ml above the lowest level (nadir) achieved after treatment, biochemical failure has occurred and the date of the failure is recorded at the time the nadir plus 2 ng/ml level is reached.
Overall Survival
The survival time will be measured from the date of accession to the date of death.
Disease Specific Survival
Disease-Specific Survival Disease-specific survival will be measured from the date of study entry to the date of death due to prostate cancer as the percentage of participants who survived the prostrate cancer disease.
Clinical Progression Including Local/Regional and Distant Relapse
Clinical progression including local/regional and distant relapse is measured using Kaplan-Meier method

Full Information

First Posted
October 19, 2007
Last Updated
December 5, 2022
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00547339
Brief Title
Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer
Official Title
A Phase I and II Study of Stereotactic Body Radiation Therapy (SBRT) for Low and Intermediate Risk Prostate Cancer (SBRT Prostate)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
July 2006 (Actual)
Primary Completion Date
July 20, 2014 (Actual)
Study Completion Date
November 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This phase I/II trial is studying the side effects and best dose of stereotactic body radiation therapy and to see how well it works in treating patients with prostate cancer.
Detailed Description
OBJECTIVES: Primary To escalate the dose of stereotactic body radiotherapy (SBRT) to a tumoricidal dose without exceeding the maximum tolerated dose in patients with organ-confined prostate cancer. (Phase I) To determine the late, severe grade 3-5 genitourinary and gastrointestinal toxicity occurring between 270-540 days (i.e., 9-18 months) from the start of the protocol treatment as assessed by CTCAE v3.0. (Phase II) Secondary To determine the dose-limiting toxicity of SBRT in these patients. (Phase I) To determine the 2-year biochemical (PSA) control (freedom from PSA failure), disease-free and overall survival, local control, freedom from distant metastases, and the incidence of high-grade adverse events of any type in patients treated with this therapy in order to determine if the therapy is promising enough for further clinical investigation. (Phase II) OUTLINE: This is a multicenter, phase I dose-escalation study followed by a phase II open-label study. Phase I: Patients undergo 5 treatments of stereotactic body radiotherapy (SBRT). Phase II: Patients undergo SBRT at the maximum tolerated dose as in phase I. After completion of study treatment, patients are followed at 1.5, 3, 6, 9, and 12 months, every 6 months for 5 years, and then once a year for years 5-10. PROJECTED ACCRUAL: A total of 97 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 1: Stereotactic Body Radiation Therapy (SBRT) 45 Gy
Arm Type
Experimental
Arm Description
The Phase 1 portion of the study will have a 3+3 design. The dose of SBRT is escalated - 45 Gy
Arm Title
Phase 1: Stereotactic Body Radiation Therapy (SBRT)- 47.5 Gy
Arm Type
Experimental
Arm Description
The Phase 1 portion of the study will have a 3+3 design. The dose of SBRT is escalated- 47.5 Gy
Arm Title
Phase 1: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy
Arm Type
Experimental
Arm Description
The Phase 1 portion of the study will have a 3+3 design. The dose of SBRT is escalated- 50 Gy
Arm Title
Phase 2: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy
Arm Type
Experimental
Arm Description
The dose of SBRT is escalated - 50 Gy in Phase 2
Intervention Type
Radiation
Intervention Name(s)
stereotactic body radiation therapy (SBRT)- 45 Gy
Intervention Description
Dose of SBRT - 45 Gray (Gy) in five fractions
Intervention Type
Radiation
Intervention Name(s)
stereotactic body radiation therapy (SBRT) - 47.5 Gy
Other Intervention Name(s)
Dose of SBRT - 47.5 Gy in five fractions
Intervention Description
Dose of SBRT - 47.5 Gray (Gy) in five fractions
Intervention Type
Radiation
Intervention Name(s)
stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 1)
Other Intervention Name(s)
Dose of SBRT - 50 Gray (Gy) in five fractions
Intervention Type
Radiation
Intervention Name(s)
stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2)
Other Intervention Name(s)
Dose of SBRT - 50 Gray (Gy) in five fractions
Primary Outcome Measure Information:
Title
Number of Participants With Dose Limiting Toxicity (Phase 1 Only)
Description
Dose-limiting toxicity (DLT) was defined as grade 3 to 5 GI, genito urinary, sexual, or neurologic toxicity attributed to therapy occurring within 90 days of registration using Common Terminology Criteria of Adverse Events(version 3)
Time Frame
90 days after start of treatment
Title
No. of Late Severe GU Toxicity (for Phase 2 Only)
Description
To determine late severe GU toxicity defined as grade 3-5 occurring between 279-540 days (i.e., 9-18 months) from the start of protocol treatment. Toxicity was defined using the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0. CTCAE uses a range of grades from 1 to 5; 1 - Mild 2 - Moderate 3 - Severe 4 - Life-threatening 5 - Death.
Time Frame
18 months
Title
No. of Late Severe GI Toxicity (for Phase 2 Only)
Description
To determine late severe GI toxicity defined as grade 3-5 occurring between 279-540 days (i.e., 9-18 months) from the start of protocol treatment. Toxicity was defined using the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0. CTCAE uses a range of grades from 1 to 5; 1 - Mild 2 - Moderate 3 - Severe 4 - Life-threatening 5 - Death.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
GU Toxicity (Only Phase 2)
Description
To determine acute severe GU toxicity is defined as grade 3-5 occurring prior to 270 days from the start of the protocol treatment. Toxicity was defined using the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0. CTCAE uses a range of grades from 1 to 5; 1 - Mild 2 - Moderate 3 - Severe 4 - Life-threatening 5 - Death.
Time Frame
9 months from start of treatment
Title
GI Toxicity
Description
To determine acute severe GI toxicity is defined as grade 3-5 occurring prior to 270 days from the start of the protocol treatment. Toxicity was defined using the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0. CTCAE uses a range of grades from 1 to 5; 1 - Mild 2 - Moderate 3 - Severe 4 - Life-threatening 5 - Death.
Time Frame
9 months from start of treatment
Title
Non-GU Toxicity
Description
To determine non-GU (genitourinary) toxicity is defined as grade 3-5. Toxicity was defined using the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0. CTCAE uses a range of grades from 1 to 5; 1 - Mild 2 - Moderate 3 - Severe 4 - Life-threatening 5 - Death.
Time Frame
60 months
Title
Non-GI Toxicity
Description
To determine non-GI (gastrointestinal) toxicity is defined as grade 3-5. Toxicity was defined using the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0. CTCAE uses a range of grades from 1 to 5; 1 - Mild 2 - Moderate 3 - Severe 4 - Life-threatening 5 - Death.
Time Frame
60 months
Title
Freedom From Biochemical Failure
Description
Biochemical failure RTOG (Radiation Therapy Oncology Group)-ASTRO (American Society for Therapeutic Radiology and Oncology) definition (also known as Phoenix definition). Thus, when the PSA rises by more than 2 ng/ml above the lowest level (nadir) achieved after treatment, biochemical failure has occurred and the date of the failure is recorded at the time the nadir plus 2 ng/ml level is reached.
Time Frame
36 months
Title
Overall Survival
Description
The survival time will be measured from the date of accession to the date of death.
Time Frame
60 months
Title
Disease Specific Survival
Description
Disease-Specific Survival Disease-specific survival will be measured from the date of study entry to the date of death due to prostate cancer as the percentage of participants who survived the prostrate cancer disease.
Time Frame
60 months
Title
Clinical Progression Including Local/Regional and Distant Relapse
Description
Clinical progression including local/regional and distant relapse is measured using Kaplan-Meier method
Time Frame
60 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Stage T1a, T1b, T1c disease Stage T2a or T2b No direct evidence of regional or distant metastases No T2c, T3, or T4 tumors Gleason score ≤ 7 Must meet the following criteria: Prostate-specific antigen (PSA) ≤ 20 ng/mL prior to starting hormonal therapy (if given) for patients with a Gleason score of 2-6 PSA ≤ 15 ng/mL prior to starting hormonal therapy (if given) for patients with a Gleason score of 7 Risk of pelvic lymph node involvement < 20% according to Roach formula Ultrasound-based volume estimation of the prostate gland ≤ 60 g PATIENT CHARACTERISTICS: Zubrod performance status 0-2 Fertile patients must use effective contraception No prior invasive malignancy, except for nonmelanoma skin cancer, unless disease-free for a minimum of 3 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix are allowed) No significant urinary obstructive symptoms American Urological Association (AUA) score of ≤ 15 (alpha blockers allowed) No history of inflammatory colitis (including Crohn disease and ulcerative colitis) No history of significant psychiatric illness No severe, active comorbidity including any of the following: Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months Transmural myocardial infarction within the past 6 months Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects Laboratory tests for liver function and coagulation parameters are not required for entry into this protocol AIDS (based on current CDC definition) or other immunocompromising condition HIV testing is not required for entry into this protocol PRIOR CONCURRENT THERAPY: See Disease Characteristics More than 9 months since prior hormonal therapy as neoadjuvant therapy or to downsize the prostate gland No prior pelvic radiotherapy No prior chemotherapy or surgery for prostate cancer No prior transurethral resection of the prostate (TURP) or cryotherapy to the prostate No plans for other concurrent post-treatment, adjuvant, antineoplastic therapy including surgery, cryotherapy, conventionally fractionated radiotherapy, hormonal therapy, or chemotherapy as part of the treatment for prostate cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert D. Timmerman, MD
Organizational Affiliation
Simmons Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Colorado Cancer Center at UC Health Sciences Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
MD Anderson Cancer Center Orlando Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
University of Minnesota Cancer Center at University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Prairie Lakes Cancer Center
City
Watertown
State/Province
South Dakota
ZIP/Postal Code
57201
Country
United States
Facility Name
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer

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