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Stereotactic Radiation Therapy in Treating Patients With Prostate Cancer

Primary Purpose

Prostate Cancer

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

questionnaire administration

implanted fiducial-based imaging

stereotactic radiosurgery

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer

Eligibility Criteria

undefined - 120 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
University Suburban Health Center
UHHS Chagrin Highlands Medical Center
UH-Westlake

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CyberKnife® stereotactic radiosurgery

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Biochemical Disease-free Survival

PSA

Disease-free Survival (Phoenix and ASTRO Definitions)

Disease-specific Survival

Overall Survival

Rate of Local Failure

Rate of Distant Failure

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

Full Information

NCT ID

NCT00619515

First Posted

February 20, 2008

Last Updated

August 8, 2019

Sponsor

Case Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00619515

Brief Title

Stereotactic Radiation Therapy in Treating Patients With Prostate Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Terminated

Why Stopped

Prematurely terminated at institution request

Study Start Date

December 2007 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Case Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

73 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CyberKnife® stereotactic radiosurgery

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

questionnaire administration

Intervention Description

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).

Intervention Type

Procedure

Intervention Name(s)

implanted fiducial-based imaging

Intervention Description

Undergo fiducial placement imaging

Intervention Type

Radiation

Intervention Name(s)

stereotactic radiosurgery

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Grade 3-5 Adverse Events as Assessed by NCI CTCAE v3.0

Description

Time Frame

Within 90 days of completing treatment

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Within 5 years of completing treatment

Title

Biochemical Disease-free Survival

Description

PSA

Time Frame

Assessed at months 3,6,12,18,24 and every 6 months through 5 years

Title

Disease-free Survival (Phoenix and ASTRO Definitions)

Time Frame

Assessed yearly for 5 years

Title

Disease-specific Survival

Time Frame

Assessed yearly for 5 years

Title

Overall Survival

Time Frame

Assessed yearly for 5 years

Title

Rate of Local Failure

Time Frame

Assessed at months 3,6,12,18,24 and every 12 months through 5 years

Title

Rate of Distant Failure

Time Frame

Assessed at months 3,6,12,18,24 and every 12 months through 5 years

Title

Time Frame

Survey at 1,6,12 months and yearly up to 5 years

10. Eligibility

Sex

Male

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lee E. Ponsky, MD

Organizational Affiliation

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

Official's Role

Study Chair

Facility Information:

Facility Name

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

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106-5065

Country

United States

Facility Name

University Suburban Health Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44121

Country

United States

Facility Name

UHHS Chagrin Highlands Medical Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

UH-Westlake

City

Westlake

State/Province

Ohio

ZIP/Postal Code

44145

Country

United States

12. IPD Sharing Statement

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Stereotactic Radiation Therapy in Treating Patients With Prostate Cancer

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