Prostate NeoplasmsPhase 4NCT01581749
Evaluation of Truebeam for Low-Intermediate Risk Prostate Cancer
A Phase 4 study testing "TrueBeam" stereotactic body radiosurgery in people with Prostate Neoplasms, run by Albert DeNittis at 1 site in United States.
Trial summary
The primary safety purpose of this study is to estimate the rates of immediate and long-term high grade (grade 3-5) gastrointestinal and genitourinary side effects during the five years after TrueBeam stereotactic body radiotherapy in low-risk and intermediate-risk prostate cancer patients. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Prostate Neoplasms
- What is being tested?
- "TrueBeam" stereotactic body radiosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically proven prostate adenocarcinoma within 1 year of enrollment
- Low risk: Gleason <or=6 \& PSA <or=10 \& Clinical Stage T1b-T2a,Nx or N0, Mx or M0
- Intermediate risk:Gleason <or=6 \& PSA<or=10 \& Clinical Stage T2b OR Gleason=7 \& PSA<or=10 \& Clinical Stage T1b-T2b OR Gleason <or=6 \& PSA > 10 \& < or =20 \& Clinical Stage T1b- T2b, Nx or NO, Mx or M0
- ECOG Performance Status 0-1
- No prior prostate radiation or other definitive therapy
Who cannot join
- implanted hardware or other material that would prohibit treatment planning or delivery
- chemotherapy for a malignancy within the previous 5 years
- history of an invasive malignancy (other than this prostate cancer,or basal or squamous skin cancers) within prior 5 years
- hormone ablation for 2 months prior to treatment or during treatment
Trial locations and contacts
1 site in 1 country.
Department of Radiation Oncology contact
United States1 site, 1 recruiting
- Recruiting
Lankenau Medical Center, Radiation Oncology
Wynnewood, Pennsylvania, 19096
About this study
Official title: Prospective Evaluation of Truebeam STX Stereotactic Body Radiosurgery for Low and Intermediate Risk Prostate Cancer
The primary safety purpose of this study is to estimate the rates of immediate and long-term high grade (grade 3-5) gastrointestinal and genitourinary side effects during the five years after TrueBeam stereotactic body radiotherapy in low-risk and intermediate-risk prostate cancer patients. The primary efficacy purpose is to compare 5 year biochemical disease free survival rates with TrueBeam to 5 year biochemical diseases free survival rates with dose-escalated external beam radiation therapy.
Read the detailed description
The prescribed PTV dose of 36.25Gy shall be given in 5 fractions using the Truebeam STx.
At one week after treatment, toxicity and AUA score will be evaluated. At 1 month following treatment, patients will be assessed for acute toxicity, and will fill out AUA form, SF-12, EPIC-26, SHIM and Utilization of Sexual Rx/Devices. At 3, 6, 12, 18, and 24 month intervals (and every 6 months thereafter, through year 5, and annually through year 10, if investigators opt to continue past year 5), patients will be seen and evaluated, including a history, physical exam, ECOG performance status, PSA, toxicity evaluation, and AUA score. In addition, at 6 months, 12 months and annually thereafter, the SF-12, EPIC-26, SHIM and Utilization of Sexual Medications/Devices will be administered. Examination and studies may be done at outside facility.
A prostate biopsy will be performed at time of biochemical or local clinical failure, and is encouraged at 2 years following treatment and at time of distant failure.
- Conditions
- Prostate Neoplasms
- Being tested
- "TrueBeam" stereotactic body radiosurgery
- Keywords
- low risk prostate cancer, intermediate risk prostate cancer, stereotactic radiosurgery
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"TrueBeam" stereotactic body radiosurgeryRadiation
36.25Gy to be delivered to the prostate in 5 fractions. There is only 1 arm in this study.
| Study group | Role | What they receive |
|---|---|---|
| 36.25Gy to prostate in 5 fractions | Other | 36.25Gy to be delivered to the prostate in 5 fractions. There is only 1 arm in this study. Receives: Radiation: "TrueBeam" stereotactic body radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute and late GI/GU toxicity rate following treatment
The study is designed to test the null hypothesis that the acute and late GI/GU toxicity rate 5 years following treatment is greater than 10% versus the alternative hypothesis that the toxicity rate is less than or equal to 10%. The sample size is determined such that there is 90% probability, or power, of identifying excessive toxicity if the true toxicity rate is 20% at the one-sided 5% significance level.
Measured: 5 years
Secondary outcomes (1)
a comparison of biochemical disease free survival in low risk patients treated with TrueBeam compared to (historical) biochemical disease free survival in patients treated with dose-escalated external beam radiation therapy
For the low-risk cohort, the study is powered to compare 5-year bDFS rates observed with TrueBeam STx to 5-year bDFS rates reported with dose-escalated external beam RT. In Beaumont's monotherapy HDR series treating LR patients, 5-yr ASTRO bDFS was 98%; in Demanes' series of 75% LR and 25% IR, this was 96%. Since TB delivers doses similar to HDR monotherapy, a conservative estimate of the success rate for TB is 97.5% for LR patients.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startOct 2011
- Primary completionDec 2017 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate NeoplasmsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albert DeNittis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Albert DeNittis, Main Line Health
- Investigators
- Albert DeNittis, MD, Principal investigator, Lankenau Medical Center, Main Line Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01581749
- Sponsor's protocol ID
- R12-3104L
- Status last verified
- Mar 2016
- First submitted
- 18 Apr 2012
- Last updated
- 23 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
King CR, Lehmann J, Adler JR, Hai J. CyberKnife radiotherapy for localized prostate cancer: rationale and technical feasibility. Technol Cancer Res Treat. 2003 Feb;2(1):25-30. doi: 10.1177/153303460300200104.
PubMed 12625751
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Truebeam STX Stereotactic Body Radiosurgery for Low and Intermediate Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT01581749
- Acronym / sponsor ID
- R12-3104L
- Conditions
- Prostate Neoplasms
- Keywords
- low risk prostate cancer, intermediate risk prostate cancer, stereotactic radiosurgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Albert DeNittisUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 20 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary safety purpose of this study is to estimate the rates of immediate and long-term high grade (grade 3-5) gastrointestinal and genitourinary side effects during the five years after TrueBeam stereotactic body radiotherapy in low-risk and intermediate-risk prostate cancer patients. The primary efficacy purpose is to compare 5 year biochemical disease free survival rates with TrueBeam to 5 year biochemical diseases free survival rates with dose-escalated external beam radiation therapy.
Detailed description
The prescribed PTV dose of 36.25Gy shall be given in 5 fractions using the Truebeam STx.
At one week after treatment, toxicity and AUA score will be evaluated. At 1 month following treatment, patients will be assessed for acute toxicity, and will fill out AUA form, SF-12, EPIC-26, SHIM and Utilization of Sexual Rx/Devices. At 3, 6, 12, 18, and 24 month intervals (and every 6 months thereafter, through year 5, and annually through year 10, if investigators opt to continue past year 5), patients will be seen and evaluated, including a history, physical exam, ECOG performance status, PSA, toxicity evaluation, and AUA score. In addition, at 6 months, 12 months and annually thereafter, the SF-12, EPIC-26, SHIM and Utilization of Sexual Medications/Devices will be administered. Examination and studies may be done at outside facility.
A prostate biopsy will be performed at time of biochemical or local clinical failure, and is encouraged at 2 years following treatment and at time of distant failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 36.25Gy to prostate in 5 fractions | Other | Radiation: "TrueBeam" stereotactic body radiosurgery36.25Gy to be delivered to the prostate in 5 fractions. There is only 1 arm in this study. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- histologically proven prostate adenocarcinoma within 1 year of enrollment
- Low risk: Gleason <or=6 \& PSA <or=10 \& Clinical Stage T1b-T2a,Nx or N0, Mx or M0
- Intermediate risk:Gleason <or=6 \& PSA<or=10 \& Clinical Stage T2b OR Gleason=7 \& PSA<or=10 \& Clinical Stage T1b-T2b OR Gleason <or=6 \& PSA > 10 \& < or =20 \& Clinical Stage T1b- T2b, Nx or NO, Mx or M0
- ECOG Performance Status 0-1
- No prior prostate radiation or other definitive therapy
Key exclusion criteria (4 listed)
- implanted hardware or other material that would prohibit treatment planning or delivery
- chemotherapy for a malignancy within the previous 5 years
- history of an invasive malignancy (other than this prostate cancer,or basal or squamous skin cancers) within prior 5 years
- hormone ablation for 2 months prior to treatment or during treatment
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 |
|---|---|---|
| "TrueBeam" stereotactic body radiosurgery36.25Gy to be delivered to the prostate in 5 fractions. There is only 1 arm in this study. | Radiation | 36.25Gy to prostate in 5 fractions |
Primary outcome
acute and late GI/GU toxicity rate following treatment
Time frame: 5 years
The study is designed to test the null hypothesis that the acute and late GI/GU toxicity rate 5 years following treatment is greater than 10% versus the alternative hypothesis that the toxicity rate is less than or equal to 10%. The sample size is determined such that there is 90% probability, or power, of identifying excessive toxicity if the true toxicity rate is 20% at the one-sided 5% significance level.
1 secondary outcome
a comparison of biochemical disease free survival in low risk patients treated with TrueBeam compared to (historical) biochemical disease free survival in patients treated with dose-escalated external beam radiation therapy
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2016.
- Background: PubMed 12625751King CR, Lehmann J, Adler JR, Hai J. CyberKnife radiotherapy for localized prostate cancer: rationale and technical feasibility. Technol Cancer Res Treat. 2003 Feb;2(1):25-30. doi: 10.1177/153303460300200104.
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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.
Department of Radiation Oncology contact
Albert DeNittis, MD principal investigator
Lankenau Medical Center, Main Line Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing "TrueBeam" stereotactic body radiosurgery in people with Prostate Neoplasms, run by Albert DeNittis 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?
The sponsor lists 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Mar 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Department of Radiation Oncology (484-476-3587), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acute and late GI/GU toxicity rate following treatment (time frame: 5 years). 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 NCT01581749, 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 23 Mar 2016; AzTrials last refreshed its copy on 7 Nov 2026.