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


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Male
Prostate Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of acute toxicities as assessed by NCI CTCAE v3.0

Outcome Description:

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.

Outcome Time Frame:

Within 90 days of completing treatment

Safety Issue:

Yes

Principal Investigator

Lee E. Ponsky, MD

Investigator Role:

Study Chair

Investigator Affiliation:

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

Authority:

United States: Federal Government

Study ID:

CASE13807

NCT ID:

NCT00619515

Start Date:

December 2007

Completion Date:

February 2013

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage I prostate cancer
  • stage II prostate cancer
  • Prostatic Neoplasms

Name

Location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
UH-WestlakeWestlake, Ohio  44145
UHHS Chagrin Highlands Medical CenterOrange Villager, Ohio  44122
University Suburban Health CenterSouth Euclid, Ohio  44121