Stereotactic Radiation Therapy in Treating Patients With Prostate Cancer

NCT00619515 | Terminated Results DMC

• 2 other identifiers: CASE13807P30CA043703
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Number of Late Grade 3-5 Toxicities as Assessed by NCI CTCAE v3.0

  Within 5 years of completing treatment

• Biochemical Disease-free Survival

  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

Study Arms (1)

CyberKnife® stereotactic radiosurgery

EXPERIMENTAL

Other: questionnaire administration; Procedure: implanted fiducial-based imaging; Radiation: stereotactic radiosurgery

Interventions

questionnaire administration OTHER

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).

CyberKnife® stereotactic radiosurgery

implanted fiducial-based imaging PROCEDURE

Undergo fiducial placement imaging

CyberKnife® stereotactic radiosurgery

stereotactic radiosurgery RADIATION

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

CyberKnife® stereotactic radiosurgery

Eligibility Criteria

• Age: Up to 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

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

Cleveland, Ohio, 44106-5065, United States

Location

University Suburban Health Center

Cleveland, Ohio, 44121, United States

Location

UHHS Chagrin Highlands Medical Center

Cleveland, Ohio, 44122, United States

Location

UH-Westlake

Westlake, Ohio, 44145, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Limitations and Caveats

The study was terminated prematurely by the IRB due to compliance issues. As per the IRB determination, data are not accessible to the study team for reporting.

Results Point of Contact

• Title: Dr. Lee Ponsky
• Organization: Case Comprehensive Cancer Center

lee.ponsky@uhhospitals.org

216-844-4831

Study Officials

• Lee E. Ponsky, MD

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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2008
• First Posted: February 21, 2008
• Study Start: December 1, 2007
• Primary Completion: September 1, 2012
• Study Completion: February 1, 2013
• Last Updated: August 22, 2019
• Results First Posted: August 22, 2019

Record last verified: 2019-08

Locations

US (4)