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Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00547339
Recruitment Status : Active, not recruiting
First Posted : October 22, 2007
Results First Posted : March 24, 2022
Last Update Posted : March 24, 2022
Sponsor:
Information provided by (Responsible Party):
Robert Timmerman, University of Texas Southwestern Medical Center

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: stereotactic body radiation therapy (SBRT)- 45 Gy Radiation: stereotactic body radiation therapy (SBRT) - 47.5 Gy Radiation: stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 1) Radiation: stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2) Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I and II Study of Stereotactic Body Radiation Therapy (SBRT) for Low and Intermediate Risk Prostate Cancer (SBRT Prostate)
Actual Study Start Date : July 2006
Actual Primary Completion Date : July 20, 2014
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Phase 1: Stereotactic Body Radiation Therapy (SBRT) 45 Gy
The Phase 1 portion of the study will have a 3+3 design. The dose of SBRT is escalated - 45 Gy
Radiation: stereotactic body radiation therapy (SBRT)- 45 Gy
Dose of SBRT - 45 Gray (Gy) in five fractions

Experimental: Phase 1: Stereotactic Body Radiation Therapy (SBRT)- 47.5 Gy
The Phase 1 portion of the study will have a 3+3 design. The dose of SBRT is escalated- 47.5 Gy
Radiation: stereotactic body radiation therapy (SBRT) - 47.5 Gy
Dose of SBRT - 47.5 Gray (Gy) in five fractions
Other Name: Dose of SBRT - 47.5 Gy in five fractions

Experimental: Phase 1: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy
The Phase 1 portion of the study will have a 3+3 design. The dose of SBRT is escalated- 50 Gy
Radiation: stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 1)
Other Name: Dose of SBRT - 50 Gray (Gy) in five fractions

Experimental: Phase 2: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy
The dose of SBRT is escalated - 50 Gy in Phase 2
Radiation: stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2)
Other Name: Dose of SBRT - 50 Gray (Gy) in five fractions




Primary Outcome Measures :
  1. Number of Participants With Dose Limiting Toxicity (Phase 1 Only) [ Time Frame: 90 days after start of treatment ]
    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)

  2. No. of Late Severe GU Toxicity (for Phase 2 Only) [ Time Frame: 18 months ]
    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.

  3. No. of Late Severe GI Toxicity (for Phase 2 Only) [ Time Frame: 18 months ]
    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 :
  1. GU Toxicity (Only Phase 2) [ Time Frame: 9 months from start of treatment ]
    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.

  2. GI Toxicity [ Time Frame: 9 months from start of treatment ]
    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.

  3. Non-GU Toxicity [ Time Frame: 60 months ]
    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.

  4. Non-GI Toxicity [ Time Frame: 60 months ]
    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.

  5. Freedom From Biochemical Failure [ Time Frame: 36 months ]
    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.

  6. Overall Survival [ Time Frame: 60 months ]
    The survival time will be measured from the date of accession to the date of death.

  7. Disease Specific Survival [ Time Frame: 60 months ]
    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.

  8. Clinical Progression Including Local/Regional and Distant Relapse [ Time Frame: 60 months ]
    Clinical progression including local/regional and distant relapse is measured using Kaplan-Meier method



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00547339


Locations
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United States, Colorado
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States, 80045
United States, Florida
MD Anderson Cancer Center Orlando Florida
Orlando, Florida, United States, 32806
United States, Minnesota
University of Minnesota Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, South Dakota
Prairie Lakes Cancer Center
Watertown, South Dakota, United States, 57201
United States, Texas
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Study Chair: Robert D. Timmerman, MD Simmons Cancer Center
  Study Documents (Full-Text)

Documents provided by Robert Timmerman, University of Texas Southwestern Medical Center:
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Responsible Party: Robert Timmerman, Professor of Medicine, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00547339    
Obsolete Identifiers: NCT03554369
Other Study ID Numbers: SCCC-0604122; STU 072010-019
SCCC-062006-010
CDR0000571546 ( Registry Identifier: PDQ (Physician Data Query) )
UMN-2006UC048
First Posted: October 22, 2007    Key Record Dates
Results First Posted: March 24, 2022
Last Update Posted: March 24, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Robert Timmerman, University of Texas Southwestern Medical Center:
adenocarcinoma of the prostate
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases