Stereotactic Radiation Therapy in Treating Patients With Prostate Cancer

Prospective Evaluation of Cyberknife Stereotactic Radiosurgery for Low and Low/Intermediate Risk Prostate Cancer

RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This trial is studying the side effects of stereotactic radiation therapy and to see how well it works in treating patients with prostate cancer.

Study Overview

• Status: Terminated
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: questionnaire administration; Procedure: implanted fiducial-based imaging; Radiation: stereotactic radiosurgery

Detailed Description

OBJECTIVES:

Primary

• To estimate in both low- and low-to-intermediate-risk groups of patients with prostate cancer, the rate of acute toxicities observed during the 5 years following CyberKnife® stereotactic radiosurgery (SRS).

Secondary

• To estimate the rate of late grade 3-5 toxicities after SRS in these patients.
• To measure biochemical disease-free survival of patients treated with this therapy.
• To measure rates of local failure, distant failure, disease-free survival, disease-specific survival, and overall survival of patients treated with this therapy.
• To measure quality of life in generic and organ-specific domains in patients treated with this therapy.
• To evaluate imaging modalities and their potential role in the detection of prostate cancer persistence, recurrence, and/or progression in patients treated with this therapy.

OUTLINE: Patients are stratified according to risk group (low risk vs low/intermediate risk).

Patients undergo fiducial placement using ultrasound. At least 5-10 days later, patients undergo CyberKnife® stereotactic radiosurgery once daily for 5 days.

Patients complete 4 questionnaires at baseline and periodically during study to assess acute and late toxicities and quality of life (e.g., overall health status, patient function, sexual function, and urinary symptoms).

After completion of study therapy, patients are followed for up to 5 years.

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106-5065
      • Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
    • Cleveland, Ohio, United States, 44121
      • University Suburban Health Center
    • Cleveland, Ohio, United States, 44122
      • UHHS Chagrin Highlands Medical Center
    • Westlake, Ohio, United States, 44145
      • UH-Westlake

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 120 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate

  • Disease confirmed by biopsy within 1 year of study entry
  • Gleason score 2-7(3+4)

  • Clinical stage T1a or T2b, N0 or NX, M0 or MX

    • T- stage and N-stage determined by physical exam and available imaging studies (i.e., ultrasound, CT scan, and/or MRI)

    • M-stage determined by physical exam, CT scan, and/or MRI

      • Bone scan is not required unless clinical findings suggest possible osseous metastases
• PSA ≤ 10 ng/mL within the past 60 days

• At risk for recurrence, as defined by 1 of the following risk groups:

  • Low-risk, defined by the following combination:

    • Stage T1a-T2a, Gleason 2-6, and PSA ≤ 10 ng/mL

  • Low- to-Intermediate-risk, defined by either of the following combinations:

    • Stage T2b, Gleason 2-6, and PSA ≤ 10 ng/mL
    • Stage T2b, Gleason 3+4=7, and PSA ≤ 10 ng/mL

• Prostate volume must be ≤ 100 cc

  • Determined by measurement from CT scan or ultrasound within the past 90 days or within the past 14 days if hormone therapy is given

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1
• No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion

PRIOR CONCURRENT THERAPY:

• No prior definitive therapy for prostate cancer, including prostatectomy, cryotherapy, or radiotherapy to the prostate or lower pelvis
• No more than 6 months of hormone ablation for gland downsizing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: CyberKnife® stereotactic radiosurgery

Other: questionnaire administration; Patients complete 4 questionnaires at baseline and periodically during study to assess acute and late toxicities and quality of life (e.g., overall health status, patient function, sexual function, and urinary symptoms).; Procedure: implanted fiducial-based imaging; Undergo fiducial placement imaging; Radiation: stereotactic radiosurgery; Patients undergo fiducial placement using ultrasound. At least 5-10 days later, patients undergo CyberKnife® stereotactic radiosurgery once daily for 5 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Grade 3-5 Adverse Events as Assessed by NCI CTCAE v3.0	This study's primary goal is to determine the rate of acute grade 3-5 toxicities following CyberKnife treatment. Per RTOG/ECOG, acute toxicity will be defined as occurring within 90 days of completing treatment.	Within 90 days of completing treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Late Grade 3-5 Toxicities as Assessed by NCI CTCAE v3.0	Late toxicity will be defined as toxicity occurring more than 90 days after treatment. It is graded based on Common Terminology Criteria for Adverse Events (CTCAE) v3.0, and RTOG/ECOG definitions.	Within 5 years of completing treatment
Biochemical Disease-free Survival	PSA	Assessed at months 3,6,12,18,24 and every 6 months through 5 years
Disease-free Survival (Phoenix and ASTRO Definitions)		Assessed yearly for 5 years
Disease-specific Survival		Assessed yearly for 5 years
Overall Survival		Assessed yearly for 5 years
Rate of Local Failure		Assessed at months 3,6,12,18,24 and every 12 months through 5 years
Rate of Distant Failure		Assessed at months 3,6,12,18,24 and every 12 months through 5 years
Quality of Life as Measured by the Short Form-12 Health Survey, Expanded Prostate Cancer Index Composite, and the American Urological Association Symptom Index, and the Utilization of Sexual Medications/Devices		Survey at 1,6,12 months and yearly up to 5 years

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Lee E. Ponsky, MD, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (ACTUAL): September 1, 2012
• Study Completion (ACTUAL): February 1, 2013

Study Registration Dates

• First Submitted: February 20, 2008
• First Submitted That Met QC Criteria: February 20, 2008
• First Posted (ESTIMATE): February 21, 2008

Study Record Updates

• Last Update Posted (ACTUAL): August 22, 2019
• Last Update Submitted That Met QC Criteria: August 8, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: adenocarcinoma of the prostate; stage I prostate cancer; stage II prostate cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CASE13807 (OTHER: Case Comprehensive Cancer Center); P30CA043703 (U.S. NIH Grant/Contract)