Stereotactic Radiation Therapy in Treating Patients With Prostate Cancer - Full Text View

Sponsor:	Case Comprehensive Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by (Responsible Party):	Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00619515

Purpose

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.

Condition	Intervention
Prostate Cancer	Other: questionnaire administration Procedure: implanted fiducial-based imaging Radiation: stereotactic radiosurgery

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Prospective Evaluation of Cyberknife Stereotactic Radiosurgery for Low and Low/Intermediate Risk Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:

Rate of acute toxicities as assessed by NCI CTCAE v3.0 [ Time Frame: Within 90 days of completing treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Rate of late grade 3-5 toxicities as assessed by NCI CTCAE v3.0 [ Time Frame: Within 90 days of completing treatment ] [ Designated as safety issue: Yes ]
Biochemical disease-free survival [ Time Frame: Assessed at months 3,6,12,18,24 and every 6 months through 5 years ] [ Designated as safety issue: No ]
Disease-free survival (Phoenix and ASTRO definitions) [ Time Frame: Assessed yearly for 5 years ] [ Designated as safety issue: No ]
Disease-specific survival [ Time Frame: Assessed yearly for 5 years ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: Assessed yearly for 5 years ] [ Designated as safety issue: No ]
Rate of local failure [ Time Frame: Assessed at months 3,6,12,18,24 and every 12 months through 5 years ] [ Designated as safety issue: No ]
Rate of distant failure [ Time Frame: Assessed at months 3,6,12,18,24 and every 12 months through 5 years ] [ Designated as safety issue: No ]
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 [ Time Frame: Survery at 1,6,12 months and yearly up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	102
Study Start Date:	December 2007
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Intervention Details:

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).

Undergo fiducial placement imaging

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

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.

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619515

Contacts

Contact: Lee Ponsky, MD

216-844-4831

lee.ponsky@uhhospitals.org

Locations

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

Sponsors and Collaborators

Case Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Lee E. Ponsky, MD

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00619515 History of Changes
Other Study ID Numbers:	CASE13807, P30CA043703, CASE13807
Study First Received:	February 20, 2008
Last Updated:	September 6, 2011
Health Authority:	United States: Federal Government

Keywords provided by Case Comprehensive Cancer Center:

adenocarcinoma of the prostate
stage I prostate cancer
stage II prostate cancer

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on February 09, 2012