Prostate CancerNCT00643994
CyberKnife Radiosurgery for Organ-Confined Prostate Cancer: Homogenous Dose Distribution
A study testing CyberKnife Stereotactic Radiosurgery in people with Prostate Cancer and Prostatic Cancer, run by Accuray Incorporated at 23 sites in United States.
Trial summary
The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostatic Cancer, Prostate Neoplasms
- What is being tested?
- CyberKnife Stereotactic Radiosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 379 participants
- Where
- 23 sitesUnited States
- Study dates
- Dec 2007to 27 Jan 2021
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must be at least 18 years of age
- Histologically proven prostate adenocarcinoma
- Patients belonging in one of the following risk groups:
- Low: Clinical Stage (CS) T1b-T2a and Gleason 2-6 and Prostate Specific Antigen (PSA) ≤ 10, or Intermediate: CS T2b and Gleason 2-6 and PSA ≤ 10 or CS T1b-T2b, and Gleason 2-6 and PSA ≤ 20 ng/ml or Gleason 7 and PSA ≤ 10 ng/ml
- Prostate volume: ≤ 100 cc
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Who cannot join
- Prior prostatectomy or cryotherapy of the prostate
- Prior radiotherapy to the prostate or lower pelvis
- Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion
- Chemotherapy for a malignancy in the last 5 years
- History of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years.
- Hormone ablation for two months prior to enrollment, or during treatment.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48106
ThedaCare Appleton Medical Center
Appleton, Wisconsin, 54911
Virginia Hospital Center
Arlington, Virginia, 22205
Northwest Community Hospital
Arlington Heights, Illinois, 60005
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Franklin Square Hospital Center
Baltimore, Maryland, 21237
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Coastal CyberKnife and Radiation Oncology
Ft. Pierce, Florida, 34982
Jupiter Medical Center & CyberKnife Center of Palm Beach
Jupiter, Florida, 33458
Scripps Cancer Center - CyberKnife of Southern California at Vista
La Jolla, California, 92037
Central Baptist Hospital
Lexington, Kentucky, 40503
The CyberKnife at Newport Diagnostic Center
Newport Beach, California, 92660
Community Cancer Center
Normal, Illinois, 61761
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
St. Mary's Regional Medical Center
Reno, Nevada, 89503
Swedish Cancer Center
Seattle, Washington, 98122
Lake Saint Louis Oncology
St Louis, Missouri, 63367
Saint Louis University
St Louis, Missouri, 63367
Hematology Oncology Associates of Central New York
Syracuse, New York, 15057
Capital Health
Trenton, New Jersey, 08618
Southwest Washington Medical Center
Vancouver, Washington, 98664
Southwest Washington Regional Cancer Center
Vancouver, Washington, 98664
Georgetown University
Washington D.C., District of Columbia, 20057
About this study
Official title: Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Homogenous Dose Distribution
The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer.
Read the detailed description
The CyberKnife Robotic Radiosurgery System is a unique radiosurgical system capable of treating tumors anywhere in the body noninvasively and with sub-millimeter accuracy. The CyberKnife System delivers radiation using a precise targeting methodology allowing a focal treatment margin around the target, thus limiting the volume of adjacent tissue receiving high doses radiation. This in turn allows the delivery of high doses of radiation to the prostate over a short series of treatments.
- Conditions
- Prostate Cancer, Prostatic Cancer, Prostate Neoplasms, Prostatic Neoplasms, Cancer of the Prostate
- Being tested
- CyberKnife Stereotactic Radiosurgery
- Keywords
- Prostate Cancer, CyberKnife, Stereotactic Radiosurgery, Radiotherapy, Radiation, Prostate Tumor, Prostate Surgery
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyberKnife Stereotactic RadiosurgeryRadiation
Also called CyberKnife
36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction
| Study group | Role | What they receive |
|---|---|---|
| CyberKnife Stereotactic Radiosurgery | Experimental | 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction in patients with low and intermediate risk prostate cancer. Receives: Radiation: CyberKnife Stereotactic Radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity
To estimate the rates of acute and late Grade 3-5 gastrointestinal and genitourinary toxicities (adverse events [AE]) observed during the 5 years following CyberKnife (CK) treatment for prostate cancer. Kaplan Meier estimates for 5-yr and 10-yr are reported.
Adverse events occurring within 3 months of treatment were categorized as acute toxicities, and those developing after 3 months were considered late toxicities.
The rates were determined using the first Grade 3 or higher adverse event per patient, reported as possibly, probably, or definitely related to CK treatment.
The Common Toxicity Criteria for Adverse Events (CTCAE) Version 3.0 was used to determine the Grade or severity of adverse events in this study, with Grade 3 being severe or medically significant but not immediately life-threatening, Grade 4 being life-threatening and Grade 5 being death related to the adverse event.
Measured: Primary Safety Endpoint was measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Biochemical Disease-Free Survival (bDFS)
To determine the rate of biochemical Disease-Free Survival (bDFS), using the Phoenix definition, following CyberKnife treatment. Kaplan Meier estimates for 5-yr and 10-yr are reported.
The Phoenix definition uses a Prostate Specific Antigen (PSA) value exceeding the patient's lowest PSA value (nadir) + 2 ng/mL as an indicator of disease recurrence. The percentage of patients who did not have such a PSA rise or receive any interventional therapy to treat prostate cancer are reported below.
Measured: Primary Efficacy Endpoint was measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Secondary outcomes (6)
Disease Control and Survival Outcomes
To determine the rates of local failure, distant failure, disease-free survival, disease-specific survival, and overall survival following CyberKnife treatment in prostate cancer patients. Kaplan Meier estimates for 5-yr and 10-yr are reported.
Measured: Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI)
AUA-SI is a 7-item self-report measure used to assess urinary urgency, frequency, and voiding symptoms with scores ranging from 0 (no symptom) to 5 (symptom occurs almost always).
Total score: 0-7 mild symptoms; 8-19 moderate symptoms; 20-35 severe symptoms
Measured: Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence
EPIC-26 is a short form version of the Expanded Prostate Cancer Index Composite, and is a validated comprehensive instrument developed to measure the health-related quality of life among men with prostate cancer. EPIC-26 consists of 26 items under 5 domains of urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal.
Answers qualitatively measure patient's bother for each symptom and are then normalized on a scale of 0 (worst) to 100 (best) to calculate domain scores if sufficient input is provided.
Measured: Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive
EPIC-26 is a short form version of the Expanded Prostate Cancer Index Composite, and is a validated comprehensive instrument developed to measure the health-related quality of life among men with prostate cancer. EPIC-26 consists of 26 items under 5 domains of urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal.
Answers qualitatively measure patient's bother for each symptom and are then normalized on a scale of 0 (worst) to 100 (best) to calculate domain scores if sufficient input is provided.
Measured: Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Quality of Life Assessments: EPIC-26 Bowel
EPIC-26 is a short form version of the Expanded Prostate Cancer Index Composite, and is a validated comprehensive instrument developed to measure the health-related quality of life among men with prostate cancer. EPIC-26 consists of 26 items under 5 domains of urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal.
Answers qualitatively measure patient's bother for each symptom and are then normalized on a scale of 0 (worst) to 100 (best) to calculate domain scores if sufficient input is provided.
Measured: Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Quality of Life Assessments: EPIC-26 Sexual
EPIC-26 is a short form version of the Expanded Prostate Cancer Index Composite, and is a validated comprehensive instrument developed to measure the health-related quality of life among men with prostate cancer. EPIC-26 consists of 26 items under 5 domains of urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal.
Answers qualitatively measure patient's bother for each symptom and are then normalized on a scale of 0 (worst) to 100 (best) to calculate domain scores if sufficient input is provided.
Measured: Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startDec 2007
- Primary completion27 Jan 2021
- Study completion27 Jan 2021
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Accuray Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Meier, MD, Study chair, Swedish Cancer CenterIrving Kaplan, MD, Study chair, Beth Israel Deaconess Medical CenterMartin Sanda, MD, Study chair, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643994
- Sponsor's protocol ID
- ACCP001.4
- Status last verified
- Apr 2023
- First submitted
- 20 Mar 2008
- Last updated
- 9 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Meier RM, Bloch DA, Cotrutz C, Beckman AC, Henning GT, Woodhouse SA, Williamson SK, Mohideen N, Dombrowski JJ, Hong RL, Brachman DG, Linson PW, Kaplan ID. Multicenter Trial of Stereotactic Body Radiation Therapy for Low- and Intermediate-Risk Prostate Cancer: Survival and Toxicity Endpoints. Int J Radiat Oncol Biol Phys. 2018 Oct 1;102(2):296-303. doi: 10.1016/j.ijrobp.2018.05.040. Epub 2018 Jun 1.
PubMed 30191864
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Homogenous Dose Distribution
- ClinicalTrials.gov ID
- NCT00643994
- Acronym / sponsor ID
- ACCP001.4
- Conditions
- Prostate Cancer, Prostatic Cancer, Prostate Neoplasms, Prostatic Neoplasms, Cancer of the Prostate
- Keywords
- Prostate Cancer, CyberKnife, Stereotactic Radiosurgery, Radiotherapy, Radiation, Prostate Tumor, Prostate Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 379 participants (actual)
- Lead sponsor
- Accuray IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- 27 Jan 2021 (actual)
- Study completion
- 27 Jan 2021 (actual)
- First posted
- 26 Mar 2008 (estimated)
- Results
- Posted 9 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer.
Detailed description
The CyberKnife Robotic Radiosurgery System is a unique radiosurgical system capable of treating tumors anywhere in the body noninvasively and with sub-millimeter accuracy. The CyberKnife System delivers radiation using a precise targeting methodology allowing a focal treatment margin around the target, thus limiting the volume of adjacent tissue receiving high doses radiation. This in turn allows the delivery of high doses of radiation to the prostate over a short series of treatments.
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 | Radiation: CyberKnife Stereotactic Radiosurgery36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction in patients with low and intermediate risk prostate cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient must be at least 18 years of age
- Histologically proven prostate adenocarcinoma
- Patients belonging in one of the following risk groups:
- Low: Clinical Stage (CS) T1b-T2a and Gleason 2-6 and Prostate Specific Antigen (PSA) ≤ 10, or Intermediate: CS T2b and Gleason 2-6 and PSA ≤ 10 or CS T1b-T2b, and Gleason 2-6 and PSA ≤ 20 ng/ml or Gleason 7 and PSA ≤ 10 ng/ml
- Prostate volume: ≤ 100 cc
Key exclusion criteria (6 listed)
- Prior prostatectomy or cryotherapy of the prostate
- Prior radiotherapy to the prostate or lower pelvis
- Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion
- Chemotherapy for a malignancy in the last 5 years
- History of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years.
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 |
|---|---|---|
| CyberKnife Stereotactic RadiosurgeryAlso: CyberKnife36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction | Radiation | CyberKnife Stereotactic Radiosurgery |
Primary outcome
Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity
Time frame: Primary Safety Endpoint was measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
To estimate the rates of acute and late Grade 3-5 gastrointestinal and genitourinary toxicities (adverse events [AE]) observed during the 5 years following CyberKnife (CK) treatment for prostate cancer. Kaplan Meier estimates for 5-yr and 10-yr are reported. Adverse events occurring within 3 months of treatment were categorized as acute toxicities, and those developing after 3 months were considered late toxicities. The rates were determined using the first Grade 3 or higher adverse event per patient, reported as possibly, probably, or definitely related to CK treatment. The Common Toxicity Criteria for Adverse Events (CTCAE) Version 3.0 was used to determine the Grade or severity of adverse events in this study, with Grade 3 being severe or medically significant but not immediately life-threatening, Grade 4 being life-threatening and Grade 5 being death related to the adverse event.
Biochemical Disease-Free Survival (bDFS)
Time frame: Primary Efficacy Endpoint was measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
To determine the rate of biochemical Disease-Free Survival (bDFS), using the Phoenix definition, following CyberKnife treatment. Kaplan Meier estimates for 5-yr and 10-yr are reported. The Phoenix definition uses a Prostate Specific Antigen (PSA) value exceeding the patient's lowest PSA value (nadir) + 2 ng/mL as an indicator of disease recurrence. The percentage of patients who did not have such a PSA rise or receive any interventional therapy to treat prostate cancer are reported below.
6 secondary outcomes
Disease Control and Survival Outcomes
Time frame: Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI)
Time frame: Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence
Time frame: Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive
Time frame: Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Quality of Life Assessments: EPIC-26 Bowel
Time frame: Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Quality of Life Assessments: EPIC-26 Sexual
Time frame: Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30191864Meier RM, Bloch DA, Cotrutz C, Beckman AC, Henning GT, Woodhouse SA, Williamson SK, Mohideen N, Dombrowski JJ, Hong RL, Brachman DG, Linson PW, Kaplan ID. Multicenter Trial of Stereotactic Body Radiation Therapy for Low- and Intermediate-Risk Prostate Cancer: Survival and Toxicity Endpoints. Int J Radiat Oncol Biol Phys. 2018 Oct 1;102(2):296-303. doi: 10.1016/j.ijrobp.2018.05.040. Epub 2018 Jun 1.
- Accuray WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Robert Meier, MD study chair
Swedish Cancer Center
Irving Kaplan, MD study chair
Beth Israel Deaconess Medical Center
Martin Sanda, MD study chair
Beth Israel Deaconess Medical Center
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CyberKnife Stereotactic Radiosurgery in people with Prostate Cancer and Prostatic Cancer, run by Accuray Incorporated at 23 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?
The sponsor lists 6 inclusion and 6 exclusion criteria. 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: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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 9 May 2023). 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?
Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity (time frame: Primary Safety Endpoint was measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00643994, which also lists 1 linked publication.
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 9 May 2023.