Prostate CancerNCT00619515
Stereotactic Radiation Therapy in Treating Patients With Prostate Cancer
A study testing questionnaire administration, implanted fiducial-based imaging and stereotactic radiosurgery in people with Prostate Cancer, run by Case Comprehensive Cancer Center at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 120 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- questionnaire administration, implanted fiducial-based imaging and stereotactic radiosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2007to Feb 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 120 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
University Suburban Health Center
Cleveland, Ohio, 44121
UHHS Chagrin Highlands Medical Center
Cleveland, Ohio, 44122
UH-Westlake
Westlake, Ohio, 44145
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- questionnaire administration, implanted fiducial-based imaging, stereotactic radiosurgery
- Keywords
- adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
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).
implanted fiducial-based imagingProcedure or surgery
Undergo fiducial placement imaging
stereotactic radiosurgeryRadiation
Patients undergo fiducial placement using ultrasound. At least 5-10 days later, patients undergo CyberKnife® stereotactic radiosurgery once daily for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| CyberKnife® stereotactic radiosurgery | Experimental | Not described Receives: Other: questionnaire administration; Procedure: implanted fiducial-based imaging; Radiation: stereotactic radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 90 days of completing treatment
Secondary outcomes (8)
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.
Measured: Within 5 years of completing treatment
Biochemical Disease-free Survival
PSA
Measured: Assessed at months 3,6,12,18,24 and every 6 months through 5 years
Disease-free Survival (Phoenix and ASTRO Definitions)
Measured: Assessed yearly for 5 years
Disease-specific Survival
Measured: Assessed yearly for 5 years
Overall Survival
Measured: Assessed yearly for 5 years
Rate of Local Failure
Measured: Assessed at months 3,6,12,18,24 and every 12 months through 5 years
Rate of Distant Failure
Measured: 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
Measured: Survey at 1,6,12 months and yearly up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2008 (estimated)
- Study startDec 2007
- Primary completionSep 2012
- Study completionFeb 2013
Why it stopped: Prematurely terminated at institution request
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lee E. Ponsky, MD, Study chair, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00619515
- Sponsor's protocol ID
- CASE13807
- Other IDs
- P30CA043703, CASE13807
- Status last verified
- Aug 2019
- First submitted
- 20 Feb 2008
- Last updated
- 22 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Cyberknife Stereotactic Radiosurgery for Low and Low/Intermediate Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT00619515
- Acronym / sponsor ID
- CASE13807
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Prematurely terminated at institution request
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2007
- Primary completion
- Sep 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 21 Feb 2008 (estimated)
- Results
- Posted 22 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CyberKnife® stereotactic radiosurgery | Experimental | Other: questionnaire administration, Procedure: implanted fiducial-based imaging, Radiation: stereotactic radiosurgery |
Who may qualify
- Ages
- Up to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire administrationPatients 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). | Other | CyberKnife® stereotactic radiosurgery |
| implanted fiducial-based imagingUndergo fiducial placement imaging | Procedure or surgery | CyberKnife® stereotactic radiosurgery |
| stereotactic radiosurgeryPatients undergo fiducial placement using ultrasound. At least 5-10 days later, patients undergo CyberKnife® stereotactic radiosurgery once daily for 5 days. | Radiation | CyberKnife® stereotactic radiosurgery |
Primary outcome
Number of Grade 3-5 Adverse Events as Assessed by NCI CTCAE v3.0
Time frame: Within 90 days of completing treatment
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.
8 secondary outcomes
Number of Late Grade 3-5 Toxicities as Assessed by NCI CTCAE v3.0
Time frame: Within 5 years of completing treatment
Biochemical Disease-free Survival
Time frame: Assessed at months 3,6,12,18,24 and every 6 months through 5 years
Disease-free Survival (Phoenix and ASTRO Definitions)
Time frame: Assessed yearly for 5 years
Disease-specific Survival
Time frame: Assessed yearly for 5 years
Overall Survival
Time frame: Assessed yearly for 5 years
Rate of Local Failure
Time frame: Assessed at months 3,6,12,18,24 and every 12 months through 5 years
Rate of Distant Failure
Time frame: 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
Time frame: Survey at 1,6,12 months and yearly up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee E. Ponsky, MD study chair
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionnaire administration, implanted fiducial-based imaging and stereotactic radiosurgery in people with Prostate Cancer, run by Case Comprehensive Cancer Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Grade 3-5 Adverse Events as Assessed by NCI CTCAE v3.0 (time frame: Within 90 days of completing treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2019.