Prostate AdenocarcinomaNCT01985828
CyberKnife® as Monotherapy or Boost SBRT for Intermediate or High Risk Localized Prostate Cancer
A study testing CyberKnife, Androgen Deprivation Therapy (ADT) and Intensity Modulated radiation therapy (IMRT) in people with Prostate Adenocarcinoma, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The primary objective of this study is to document the effectiveness of Cyberknife stereotactic body radiotherapy (SBRT) in the treatment of intermediate and high-risk localized prostate cancer defined by biochemical Disease-Free Survival (bDFS), using Phoenix and American Society of Therapeutic Radiation and Oncology… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma
- What is being tested?
- CyberKnife, Androgen Deprivation Therapy (ADT) and Intensity Modulated radiation therapy (IMRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2013to Aug 2019
- 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
- Patient must be ≥ 18 years of age.
- Histologically proven prostate adenocarcinoma
- Gleason score 2-10 (reviewed by reference lab)
- Biopsy within one year of date of registration
- Clinical stage T1b-T4, N0-Nx, M0-Mx (AJCC 7th Edition)
- T-stage and N-stage determined by physical exam and available imaging studies (ultrasound, CT, and/or MRI; see section 4.5)
- M-stage determined by physical exam, CT or MRI. Bone scan not required unless clinical findings suggest possible osseous metastases.
- PSA ≤ 50 ng/ml, CBC, platelets, BUN, creatinine prior to treatment
- Patients belonging in one of the following risk groups:
- Intermediate: CS T2b-c and Gleason <6 and PSA ≤ 10, or CS T1b-T2b, and Gleason 7 and PSA ≤ 10 ng/ml, or Gleason <6 and PSA 11-20 ng/ml
- High: CS T3-4, Gleason score >7and PSA<50
- Prostate volume: ≤ 100 cc
- Determined using: volume = π/6 x length x height x width
- Measurement from MRI, CT or ultrasound prior to registration.
- ECOG performance status 0-1
- No prior prostatectomy or cryotherapy of the prostate
- No prior radiotherapy to the prostate or lower pelvis
- No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
- No chemotherapy for a malignancy in the last 5 years.
- No history of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years.
Trial locations and contacts
1 site in 1 country.
United States1 site
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
About this study
Official title: Prospective Evaluation of CyberKnife® as Monotherapy or Boost Stereotactic Body Radiotherapy for Intermediate or High Risk Localized Prostate Cancer
The primary objective of this study is to document the effectiveness of Cyberknife stereotactic body radiotherapy (SBRT) in the treatment of intermediate and high-risk localized prostate cancer defined by biochemical Disease-Free Survival (bDFS), using Phoenix and American Society of Therapeutic Radiation and Oncology (ASTRO) definitions, at 5 years.
During the prostate-specific antigen era, an ever-increasing percentage of men with prostate cancer have presented with clinically localized, potentially curable disease. Although conventional treatment options are potentially curative in selected patients, these treatments also have drawbacks, including the risk of negative long-term quality of life consequences and serious complications.
Read more
The CyberKnife® system is a type of radiation machine that uses a special system to precisely focus large doses of x-rays on the tumor. The device is designed to concentrate large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal.
Intermediate risk patients will be treated with either CyberKnife® Stereotactic Body Radiation Therapy (SBRT) monotherapy or CyberKnife® SBRT boost followed by Intensity Modulated Radiation Therapy (IMRT). High risk patients will be treated with CyberKnife® SBRT boost followed by IMRT. Treatment will last 4-7 days. Patients will complete the QOL questionnaires before treatment. Questionnaires will also be completed during follow-up visits at 1, 3 , 6, 12, 18, 24, 30 and 36 months then every 12 months until year 5.
Read the detailed description
The purpose of this project is to evaluate the efficacy and Health-Related Quality of Life (HRQOL) in intermediate and high-risk prostate cancer patients treated with SBRT as monotherapy or as a boost in combination with IMRT.
- Conditions
- Prostate Adenocarcinoma
- Being tested
- CyberKnife, Androgen Deprivation Therapy (ADT), Intensity Modulated radiation therapy (IMRT)
- Keywords
- Prostate neoplasm, 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.
CyberKnifeRadiation
Androgen Deprivation Therapy (ADT)Other
Intensity Modulated radiation therapy (IMRT)Radiation
Per current standard of care
| Study group | Role | What they receive |
|---|---|---|
| Intermediate Risk | Experimental | Short term (4-6 months) androgen deprivation therapy (ADT) per current standard of care + CyberKnife 21 Gy (7 Gy x 3) and Prostate/SV Intensity Modulated radiation therapy (IMRT) 45-50.4 Gy
OR
Short term (4-6 months)androgen deprivation therapy + CyberKnife 36.35 Gray (7.27 Gray x 5) Receives: Radiation: CyberKnife; Other: Androgen Deprivation Therapy (ADT); Radiation: Intensity Modulated radiation therapy (IMRT) |
| High Risk | Experimental | Short or Long term (6 months - 3 years) androgen deprivation therapy (ADT) + 45-50.4 Gy and Pelvis Intensity Modulated radiation therapy (IMRT) per current standard of care + 21 Gy (7 Gy x 3) CyberKnife boost Receives: Radiation: CyberKnife; Other: Androgen Deprivation Therapy (ADT); Radiation: Intensity Modulated radiation therapy (IMRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical Disease-Free Survival (bDFS), Using Phoenix and ASTRO Definitions
Phoenix definition: Biochemical recurrence of prostate cancer (PCa) after curative radiotherapy defined as a prostate-specific antigen (PSA) rise of ≥2 ng/ml above the nadir.
Astro definition: Biochemical failure in prostate cancer defined as three consecutive rises in prostate-specific antigen (PSA) after a nadir.
Measured: 3 years
Secondary outcomes (2)
Measure the Rates of Acute and Late Grade 3-5 Gastrointestinal and Genitourinary Toxicity
Acute toxicity is graded based upon Common Terminology Criteria for Adverse Events (CTCAE). The Common Terminology Criteria for Adverse Events (CTCAE) v3.0 is a standardized system used to classify and grade the severity of adverse events (AEs) experienced by cancer patients during treatment, with a grading scale ranging from 1 (mild) to 5 (death).
Measured: 3 years
Expanded Prostate Cancer Index Composite Epic-26
The 26-item version of EPIC, also known as EPIC Short Form or EPIC-26, contains five symptom domains (urinary incontinence, urinary irritative/obstructive, sexual, bowel, hormonal), scored from 0 (worst) to 100 (best).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study start19 Nov 2013
- Primary completionSep 2018
- Study completionAug 2019
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 AdenocarcinomaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arica Hirsch, MD, Principal investigator, Advocate Lutheran General HospitalMajid M Mohiuddin, MD, Study chair, Advocate Lutheran General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01985828
- Sponsor's protocol ID
- 5307
- Status last verified
- Jun 2024
- First submitted
- 12 Apr 2013
- Last updated
- 3 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of CyberKnife® as Monotherapy or Boost Stereotactic Body Radiotherapy for Intermediate or High Risk Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT01985828
- Acronym / sponsor ID
- 5307
- Conditions
- Prostate Adenocarcinoma
- Keywords
- Prostate neoplasm, Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 19 Nov 2013 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 15 Nov 2013 (estimated)
- Results
- Posted 1 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to document the effectiveness of Cyberknife stereotactic body radiotherapy (SBRT) in the treatment of intermediate and high-risk localized prostate cancer defined by biochemical Disease-Free Survival (bDFS), using Phoenix and American Society of Therapeutic Radiation and Oncology (ASTRO) definitions, at 5 years.
During the prostate-specific antigen era, an ever-increasing percentage of men with prostate cancer have presented with clinically localized, potentially curable disease. Although conventional treatment options are potentially curative in selected patients, these treatments also have drawbacks, including the risk of negative long-term quality of life consequences and serious complications.
The CyberKnife® system is a type of radiation machine that uses a special system to precisely focus large doses of x-rays on the tumor. The device is designed to concentrate large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal.
Intermediate risk patients will be treated with either CyberKnife® Stereotactic Body Radiation Therapy (SBRT) monotherapy or CyberKnife® SBRT boost followed by Intensity Modulated Radiation Therapy (IMRT). High risk patients will be treated with CyberKnife® SBRT boost followed by IMRT. Treatment will last 4-7 days. Patients will complete the QOL questionnaires before treatment. Questionnaires will also be completed during follow-up visits at 1, 3 , 6, 12, 18, 24, 30 and 36 months then every 12 months until year 5.
Detailed description
The purpose of this project is to evaluate the efficacy and Health-Related Quality of Life (HRQOL) in intermediate and high-risk prostate cancer patients treated with SBRT as monotherapy or as a boost in combination with IMRT.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermediate Risk | Experimental | Radiation: CyberKnife, Other: Androgen Deprivation Therapy (ADT), Radiation: Intensity Modulated radiation therapy (IMRT)Short term (4-6 months) androgen deprivation therapy (ADT) per current standard of care + CyberKnife 21 Gy (7 Gy x 3) and Prostate/SV Intensity Modulated radiation therapy (IMRT) 45-50.4 Gy OR Short term (4-6 months)androgen deprivation therapy + CyberKnife 36.35 Gray (7.27 Gray x 5) |
| High Risk | Experimental | Radiation: CyberKnife, Other: Androgen Deprivation Therapy (ADT), Radiation: Intensity Modulated radiation therapy (IMRT)Short or Long term (6 months - 3 years) androgen deprivation therapy (ADT) + 45-50.4 Gy and Pelvis Intensity Modulated radiation therapy (IMRT) per current standard of care + 21 Gy (7 Gy x 3) CyberKnife boost |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| CyberKnife | Radiation | High Risk, Intermediate Risk |
| Androgen Deprivation Therapy (ADT) | Other | High Risk, Intermediate Risk |
| Intensity Modulated radiation therapy (IMRT)Per current standard of care | Radiation | High Risk, Intermediate Risk |
Primary outcome
Biochemical Disease-Free Survival (bDFS), Using Phoenix and ASTRO Definitions
Time frame: 3 years
Phoenix definition: Biochemical recurrence of prostate cancer (PCa) after curative radiotherapy defined as a prostate-specific antigen (PSA) rise of ≥2 ng/ml above the nadir. Astro definition: Biochemical failure in prostate cancer defined as three consecutive rises in prostate-specific antigen (PSA) after a nadir.
2 secondary outcomes
Measure the Rates of Acute and Late Grade 3-5 Gastrointestinal and Genitourinary Toxicity
Time frame: 3 years
Expanded Prostate Cancer Index Composite Epic-26
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- 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.
Arica Hirsch, MD principal investigator
Advocate Lutheran General Hospital
Majid M Mohiuddin, MD study chair
Advocate Lutheran General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CyberKnife, Androgen Deprivation Therapy (ADT) and Intensity Modulated radiation therapy (IMRT) in people with Prostate Adenocarcinoma, run by Wake Forest University Health Sciences at 1 site 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: finished, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 Oct 2024). 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?
Biochemical Disease-Free Survival (bDFS), Using Phoenix and ASTRO Definitions (time frame: 3 years). 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 3 Oct 2024.