Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer

Phase 1

Completed

• Conditions: Prostate Cancer
• Interventions: Radiation: stereotactic body radiation therapy (SBRT)- 45 Gy; Radiation: stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 1); Radiation: stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2); Radiation: stereotactic body radiation therapy (SBRT) - 47.5 Gy

• Registration Number: NCT00547339
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2007-10-19
• Study First Submitted QC: 2007-10-19
• Study First Posted: 2007-10-22
• Primary Completion: 2014-07-20
• Results First Submitted: 2021-12-08
• Results First Submitted QC: 2022-03-23
• Results First Posted: 2022-03-24
• Study Completion: 2022-11-28
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-05
• Last Update Posted: 2022-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 94

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phase 1: Stereotactic Body Radiation Therapy (SBRT) 45 Gy	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
Phase 1: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy	stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 1)	The Phase 1 portion of the study will have a 3+3 design. The dose of SBRT is escalated- 50 Gy
Phase 2: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy	stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2)	The dose of SBRT is escalated - 50 Gy in Phase 2
Phase 1: Stereotactic Body Radiation Therapy (SBRT)- 47.5 Gy	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

Primary Outcome Measures

Name	Time	Method
Number of Participants With Dose Limiting Toxicity (Phase 1 Only)	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)
No. of Late Severe GU Toxicity (for Phase 2 Only)	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.
No. of Late Severe GI Toxicity (for Phase 2 Only)	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

Name	Time	Method
GU Toxicity (Only Phase 2)	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.
GI Toxicity	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.
Non-GU Toxicity	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.
Non-GI Toxicity	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.
Freedom From Biochemical Failure	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.
Overall Survival	60 months	The survival time will be measured from the date of accession to the date of death.
Disease Specific Survival	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.
Clinical Progression Including Local/Regional and Distant Relapse	60 months	Clinical progression including local/regional and distant relapse is measured using Kaplan-Meier method

Trial Locations

Locations (5)

University of Minnesota Cancer Center at University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

MD Anderson Cancer Center Orlando Florida; 🇺🇸 Orlando, Florida, United States

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas; 🇺🇸 Dallas, Texas, United States

Prairie Lakes Cancer Center; 🇺🇸 Watertown, South Dakota, United States

University of Colorado Cancer Center at UC Health Sciences Center; 🇺🇸 Aurora, Colorado, United States