Prostate CancerNCT00643617

CyberKnife Radiosurgery For Low & Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry

A study testing CyberKnife Stereotactic Radiosurgery - Low Risk and CyberKnife Stereotactic Radiosurgery - Intermediate Risk in people with Prostate Cancer and Prostatic Cancer, run by Accuray Incorporated at 18 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to investigate the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer and to evaluate the effects of this treatment on the quality of life over time. 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, Prostatic Neoplasms
What is being tested?: CyberKnife Stereotactic Radiosurgery - Low Risk and CyberKnife Stereotactic Radiosurgery - Intermediate Risk
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 307 participants
Where: 18 sitesUnited States
Study dates: 22 Oct 2007to 7 Apr 2022
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
Biopsy within 1 year of date of registration
Clinical Stage (CS) T1b-T2b, N0, M0
Patients belonging to one of the following risk categories:
Low Risk: CS T1b-T2a, Gleason Score 2-6, Prostate Specific Antigen (PSA) < or = 10 ng/ml
Intermediate Risk: CS T2b, Gleason Score 2-6, PSA < or = 10 ng/ml or CS T1b-T2b, Gleason Score 2-6, PSA < or = 20 ng/ml or CS T1b-T2b, Gleason Score 7 and PSA < or = 10 ng/ml
Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Who cannot join

Clinical Stage T2c or greater
Prior prostatectomy or cryotherapy of the prostate
Prior radiotherapy of the prostate or lower pelvis
Implanted hardware or other material that would prohibit appropriate treatment planning or delivery
History of an invasive malignancy other than 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

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

United States18 sites

New Millenium CyberKnife
Brandon, Florida, 33511
University of North Carolina
Chapel Hill, North Carolina, 27599
Penrose Cancer Center
Colorado Springs, Colorado, 80907
AtlantiCare Regional Medical Center
Egg Harbor, New Jersey, 08234
Elmhurst Memorial Hospital
Elmhurst, Illinois, 60126
Community Regional Medical Center
Fresno, California, 93721
Benefis Health System - Sletten Cancer Institute
Great Falls, Montana, 59405
Colorado Cyberknife
Lafayette, Colorado, 80026
JFK Comprehensive Cancer Center
Lake Worth, Florida, 33461
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89128
Long Beach Memorial Medical Center
Long Beach, California, 90806
Mitchell Cancer Center University of South Alabama
Mobile, Alabama, 36604
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
St. Anthony Hospital
Oklahoma City, Oklahoma, 73102
Pasadena Cyberknife Center
Pasadena, California, 91105
CyberKnife Centers of San Diego
San Diego, California, 92101
East Texas Medical Center
Tyler, Texas, 75701
South Florida Radiation Oncology
Wellington, Florida, 33449

Other trials in United States

About this study

Official title: Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry

Read the detailed description

In this study, CyberKnife radiosurgery will be used to produce dose distributions comparable to those created by High Dose Rate (HDR) brachytherapy treatment, without the use of invasive catheters. The radiosurgery volumes will closely be made to resemble HDR brachytherapy therapeutic volumes with similar dose limitation objectives to adjacent normal tissues.

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, Prostatic Neoplasms, Prostate Neoplasms, Cancer of the Prostate
Being tested: CyberKnife Stereotactic Radiosurgery - Low Risk, CyberKnife Stereotactic Radiosurgery - Intermediate Risk
Keywords: Prostate Cancer, CyberKnife, Stereotactic Radiosurgery, Radiosurgery, 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 Radiosurgery - Low RiskRadiation
Also called CyberKnife
38 Gy delivered in 4 fractions of 9.5 Gy per fraction with a radial margin of 2 mm around the prostate
CyberKnife Stereotactic Radiosurgery - Intermediate RiskRadiation
Also called CyberKnife
38 Gy delivered in 4 fractions of 9.5 Gy per fraction with a radial margin of 5mm posterolaterally

Study groups in NCT00643617
Study group	Role	What they receive
Heterogeneous Dose	Other	38 Gy delivered in 4 fractions of 9.5 Gy per fraction Receives: Radiation: CyberKnife Stereotactic Radiosurgery - Low Risk; Radiation: CyberKnife Stereotactic Radiosurgery - Intermediate Risk

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 in both low-risk and intermediate-risk cohorts 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 survival curves for bDFS were created and the 5-yr and 10-yr percentages are reported.
The Phoenix definition uses a Prostate Specific Antigen (PSA) value exceeding the patients 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.
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: AUA questionnaire was completed at Baseline, CK Treatment, and post treatment at: 1 week, 1 month, 3 months, 6 months, and then biannually up to 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.

22 Oct 20077 Apr 2022

First posted26 Mar 2008 (estimated)
Study start22 Oct 2007
Primary completion7 Apr 2022
Study completion7 Apr 2022

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.
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: 307 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00643617
Sponsor's protocol ID: ACCP002.2
Status last verified: May 2023
First submitted: 20 Mar 2008
Last updated: 9 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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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: Emulating HDR Brachytherapy Dosimetry
ClinicalTrials.gov ID: NCT00643617
Acronym / sponsor ID: ACCP002.2
Conditions: Prostate Cancer, Prostatic Cancer, Prostatic Neoplasms, Prostate Neoplasms, Cancer of the Prostate
Keywords: Prostate Cancer, CyberKnife, Stereotactic Radiosurgery, Radiosurgery, Prostate Tumor, Prostate Surgery
Study type: Interventional
Recruitment status: Completed
Enrolment: 307 participants (actual)
Lead sponsor: Accuray IncorporatedIndustry (pharma, biotech, devices)
Study start: 22 Oct 2007 (actual)
Primary completion: 7 Apr 2022 (actual)
Study completion: 7 Apr 2022 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Heterogeneous Dose	Other	Radiation: CyberKnife Stereotactic Radiosurgery - Low Risk, Radiation: CyberKnife Stereotactic Radiosurgery - Intermediate Risk38 Gy delivered in 4 fractions of 9.5 Gy per fraction

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Patient must be at least 18 years of age
Histologically proven prostate adenocarcinoma
Biopsy within 1 year of date of registration
Clinical Stage (CS) T1b-T2b, N0, M0
Patients belonging to one of the following risk categories:

Key exclusion criteria (6 listed)

Clinical Stage T2c or greater
Prior prostatectomy or cryotherapy of the prostate
Prior radiotherapy of the prostate or lower pelvis
Implanted hardware or other material that would prohibit appropriate treatment planning or delivery
History of an invasive malignancy other than 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 Radiosurgery - Low RiskAlso: CyberKnife38 Gy delivered in 4 fractions of 9.5 Gy per fraction with a radial margin of 2 mm around the prostate	Radiation	Heterogeneous Dose
CyberKnife Stereotactic Radiosurgery - Intermediate RiskAlso: CyberKnife38 Gy delivered in 4 fractions of 9.5 Gy per fraction with a radial margin of 5mm posterolaterally	Radiation	Heterogeneous Dose

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 in both low-risk and intermediate-risk cohorts 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 survival curves for bDFS were created and the 5-yr and 10-yr percentages are reported. The Phoenix definition uses a Prostate Specific Antigen (PSA) value exceeding the patients 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: AUA questionnaire was completed at Baseline, CK Treatment, and post treatment at: 1 week, 1 month, 3 months, 6 months, and then biannually up to 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

Results posted to the registry on 9 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Low Risk	112	64
Intermediate Risk	147	87

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.. Number. Unit: percentage of participants

Measure	Low Risk n = 112	Intermediate Risk n = 147
Probability of experiencing Acute GI Grade 3+ event(s)	0	0
Probability of experiencing Acute GU Grade 3+ event(s)	1.8	0.7
Probability of experiencing Late GI Grade 3+ events 5 years post treatment	0	0
Probability of experiencing Late GU Grade 3+ events 5 years post treatment	1.0	3.7
Probability of experiencing Late GI Grade 3+ event(s) at 10 years post CK treatment	0	0
Probability of experiencing Late GU Grade 3+ event(s) at 10 years post CK treatment	1.0	3.7

Primary outcome: 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.. Number. Unit: percentage of participants

Measure	Low Risk n = 112	Intermediate Risk n = 147
Probability of remaining disease-free at 5 years post-CyberKnife treatment	100	89.1
Probability of remaining disease-free at 10 years post-CyberKnife treatment	100	80

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CK treatment.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low Risk	17 of 112 (15.2%)	103 of 112 (92%)	9 of 112
Intermediate Risk	25 of 147 (17%)	142 of 147 (96.6%)	14 of 147

Limitations and caveats (from the sponsor): A limitation of this study is that of the 18 sites originally enrolling eligible patients, only 7 opted to participate in the extension of follow-up through 10 years. However, from these 7 sites, 130 patients, out of the 151 total patients who completed 5-year follow-up, consented to continue follow-up beyond 5 years.

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.
Accuray WebsiteLink provided by the sponsor.

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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.

Donald B Fuller, MD study chair

CyberKnife Centers at San Diego, CA

George Mardirossian, PhD study chair

CyberKnife Centers of San Diego, CA

18 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 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 18 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 NCT00643617.

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.