Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer

NCT ID: NCT00547339

Last Updated: 2022-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2022-11-28

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

stereotactic body radiation therapy (SBRT)- 45 Gy

Intervention Type: RADIATION

Dose of SBRT - 45 Gray (Gy) in five fractions

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

Group Type: EXPERIMENTAL

stereotactic body radiation therapy (SBRT) - 47.5 Gy

Intervention Type: RADIATION

Dose of SBRT - 47.5 Gray (Gy) in five fractions

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

Group Type: EXPERIMENTAL

stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 1)

Intervention Type: RADIATION

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

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

Group Type: EXPERIMENTAL

stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2)

Intervention Type: RADIATION

Interventions

stereotactic body radiation therapy (SBRT)- 45 Gy

Dose of SBRT - 45 Gray (Gy) in five fractions

Intervention Type: RADIATION

stereotactic body radiation therapy (SBRT) - 47.5 Gy

Dose of SBRT - 47.5 Gray (Gy) in five fractions

Intervention Type: RADIATION

stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 1)

Intervention Type: RADIATION

stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2)

Intervention Type: RADIATION

Other Intervention Names

Dose of SBRT - 47.5 Gy in five fractions; Dose of SBRT - 50 Gray (Gy) in five fractions; Dose of SBRT - 50 Gray (Gy) in five fractions

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Robert Timmerman

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert D. Timmerman, MD

Role: STUDY_CHAIR

Simmons Cancer Center

Locations

University of Colorado Cancer Center at UC Health Sciences Center

Aurora, Colorado, United States

MD Anderson Cancer Center Orlando Florida

Orlando, Florida, United States

University of Minnesota Cancer Center at University of Minnesota

Minneapolis, Minnesota, United States

Prairie Lakes Cancer Center

Watertown, South Dakota, United States

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SCCC-062006-010

Identifier Type: -

Identifier Source: secondary_id

CDR0000571546

Identifier Type: REGISTRY

Identifier Source: secondary_id

UMN-2006UC048

Identifier Type: -

Identifier Source: secondary_id

SCCC-0604122; STU 072010-019

Identifier Type: -

Identifier Source: org_study_id

NCT03554369

Identifier Type: -

Identifier Source: nct_alias