Prostate CancerNCT01856855
Pilot Trial Evaluating Stereotactic Body Radiotherapy With Integrated Boost for Clinically Localized Prostate Cancer (RAD 1203)
A study testing Stereotactic Body Radiation Therapy with Integrated Boost in people with Prostate Cancer and Prostate Adenocarcinoma, run by John Fiveash, MD at 1 site in United States.
Trial summary
This study will investigate the safety, tolerability, and effectiveness of giving a higher dose to the part of the prostate which contains the cancer while giving a standard radiation dose to the entire prostate. Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Adenocarcinoma, Radiation Toxicity
- What is being tested?
- Stereotactic Body Radiation Therapy with Integrated Boost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Dec 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 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients must have Histologically confirmed prostate adenocarcinoma, with biopsies obtained within twelve months of patient registration
- NCCN risk category very low, low, or intermediate risk
- Combined Gleason score <7
- PSA within three months of enrollment < 20ng/ml
- Clinical stage T1a-c N0M0 or clinical stage T2aN0M0
- Life expectancy > 5 years
Show all 10Show fewer
- Risk of malignant lymph node involvement < 15% as calculated on Partin tables
- Karnofsky performance status (KPS) > 60
- Age > 19 years
- Subjects given written informed consent
Who cannot join
- History of inflammatory bowel disease
- Prior radical prostate surgery, transurethral resection of the prostate(TURP), or prostate cryotherapy
- Patients using immunosuppressive medications or other medications that may increase radiation toxicity such as methotrexate, sirolimus, tacrolimus, or colchicine that are unable to discontinue these medications during SBRT course. Use of corticosteroids are not considered an exclusion criteria.
- Platelet count < 70
- Patients unable to discontinue anti-platelet or anti-coagulant medicine such as clopidogrel, dabigatran, warfarin, or low molecular weight heparin. Use of aspirin is not an exclusion criteria.
- Pre-SBRT prostate volume > 120 cc as estimated by trans-rectal ultrasound at time of prostate biopsy (TRUS biopsy).
- Risk of malignant lymph node involvement > 15% as calculated on Partin tables.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hazelrig-Salter Radiation Oncology Center
Birmingham, Alabama, 35249
About this study
Official title: RAD 1203: Pilot Trial Evaluating Stereotactic Body Radiotherapy With Integrated Boost for Clinically Localized Prostate Cancer
This study will investigate the safety, tolerability, and effectiveness of giving a higher dose to the part of the prostate which contains the cancer while giving a standard radiation dose to the entire prostate. The investigators have hypothesized that this treatment technique will effectively control the prostate cancer while minimizing the side effects.
Read the detailed description
Objectives:
Primary
-Clinically assess the early toxicity of SBRT with integrated boost for clinically localized prostate cancer
Secondary
- Determine the technical feasibility of stereotactic body radiotherapy (SBRT) with integrated boost for clinically localized prostate cancer
- Determine the treatment planning and dosimetric feasibility
- Evaluate the treatment delivery quality assurance
- Clinically assess early efficacy, late toxicity, and quality of life for patients receiving SBRT with integrated boost for clinically localized prostate cancer
Patients will undergo 5 total radiation treatments over 7-17 day period.
Patients will be asked to complete American Urological Association Symptom Index (AUA SI), Sexual Health Inventory of Men (SHIM), and the Expanded Prostate Index Composite (EPIC)questionnaires. The EPIC assesses bowel, urinary, and sexual function. These questionnaires will be completed at the following time points: Baseline, AUA SI will be collected on the last day of treatment, and every 3 months for the first year following the start of radiation, then every 6 months for year 2.
After completion of study therapy, patients are followed-up every 3 months for the first year, then every 6 months for year 2.
- Being tested
- Stereotactic Body Radiation Therapy with Integrated Boost
- Keywords
- Prostate Cancer, Prostate Adenocarcinoma, Radiation, SBRT, Stereotactic Body Radiation Therapy
- Medical subject headings
- Prostatic Neoplasms, Radiation Injuries, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation Therapy with Integrated BoostRadiation
Also called SBRT, IMRT, VMAT
SBRT with Integrated boost at 7.25 Gy and 8.00 Gy per fraction for five fractions
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Body Radiation Therapy with Integrated Boost | Experimental | Not described Receives: Radiation: Stereotactic Body Radiation Therapy with Integrated Boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Who Experienced Early Toxicity of SBRT With Integrated Boost for Localized Prostate Cancer
Early toxicity (defined as events occurring within 90 days of therapy) will be assessed by physician history and physical exams and patient toxicity/quality-of-life questionnaires to be administered at regular intervals.
Measured: Within 3 months of the completion of radiation therapy
Secondary outcomes (4)
Treatment Planning Feasibility
Feasibility will be defined as the ability of the treatment planner to create a plan that meets the following criteria:
- 100% of radiation target prescription (36.25 Gy) covers greater than or equal to 95% of the target (prostate)
- At least 95% of the boost prostate (area within the prostate most likely harboring cancer) prescription (38.0 Gy) covers 95% of this boost target volume
- All normal tissue dose constraints are met -i.e., nearby rectum, bladder, and femoral heads do not exceed the recommended radiation dose limits
If the physician must utilize a plan that compromises target coverage or normal tissue dose constraints to levels not meeting the criteria above, then the plan will be scored as not meeting technical feasibility requirements.
Measured: Within 6 months of completion of radiation therapy
Early Efficacy
Efficacy will be defined as the absence of biochemically detected (via PSA lab testing) prostate cancer or clinically detected prostate cancer at each interval follow-up visit (every three months for year one, then every 6 months for year two after treatment). "Absence of prostate cancer" is defined as no evidence of tumor recurrence by two methods:
- No prostate cancer recurrence evident on the physical examination performed by the physician.
- No rise in the PSA more than 2 ng/ml above the lowest PSA value ever obtained pre or post treatment. A rise in the PSA more than 2 ng/ml from a patient's lowest value is the standard definition for post-radiation PSA biochemical prostate cancer failure.
Measured: Within 6 months of completion of radiation therapy
Number of Patients Who Experienced Late Toxicity
Late toxicity (defined as toxicity occuring >90 days after treatment) will be assessed with regular clinical exams and patient toxicity questionnaires.
Measured: Within 6 months of completion of radiation therapy
Median Quality of Life Score
Median of quality of life score will be assessed with regular clinical exams and patient quality of life questionnaires (American Urologic Association Symptom Index score ranges from 0 to 35 with the higher scores indicating more severe, Sexual Health Inventory score ranges from 1 to 25 with 1 being severe and 25 being no signs, Extended Prostate Cancer Index Composite- Bowel, Extended Prostate Cancer Index Composite- Urinary, and Extended Prostate Cancer Index Composite- Sexual scales range from 1 (worst) to 100 (best)).
Measured: Within 6 months of completion of radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2021
- Study completionDec 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Fiveash, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John Fiveash, MD, University of Alabama at Birmingham
- Investigators
- John B Fiveash, MD, Principal investigator, University of Alabama at Birmingham Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01856855
- Sponsor's protocol ID
- F121218006
- Status last verified
- Dec 2022
- First submitted
- 10 Apr 2013
- Last updated
- 12 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAD 1203: Pilot Trial Evaluating Stereotactic Body Radiotherapy With Integrated Boost for Clinically Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT01856855
- Acronym / sponsor ID
- F121218006
- Keywords
- Prostate Cancer, Prostate Adenocarcinoma, Radiation, SBRT, Stereotactic Body Radiation Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- John Fiveash, MDUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 17 May 2013 (estimated)
- Results
- Posted 12 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the safety, tolerability, and effectiveness of giving a higher dose to the part of the prostate which contains the cancer while giving a standard radiation dose to the entire prostate. The investigators have hypothesized that this treatment technique will effectively control the prostate cancer while minimizing the side effects.
Detailed description
Objectives:
Primary
-Clinically assess the early toxicity of SBRT with integrated boost for clinically localized prostate cancer
Secondary
- Determine the technical feasibility of stereotactic body radiotherapy (SBRT) with integrated boost for clinically localized prostate cancer
- Determine the treatment planning and dosimetric feasibility
- Evaluate the treatment delivery quality assurance
- Clinically assess early efficacy, late toxicity, and quality of life for patients receiving SBRT with integrated boost for clinically localized prostate cancer
Patients will undergo 5 total radiation treatments over 7-17 day period.
Patients will be asked to complete American Urological Association Symptom Index (AUA SI), Sexual Health Inventory of Men (SHIM), and the Expanded Prostate Index Composite (EPIC)questionnaires. The EPIC assesses bowel, urinary, and sexual function. These questionnaires will be completed at the following time points: Baseline, AUA SI will be collected on the last day of treatment, and every 3 months for the first year following the start of radiation, then every 6 months for year 2.
After completion of study therapy, patients are followed-up every 3 months for the first year, then every 6 months for year 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Body Radiation Therapy with Integrated Boost | Experimental | Radiation: Stereotactic Body Radiation Therapy with Integrated Boost |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- All patients must have Histologically confirmed prostate adenocarcinoma, with biopsies obtained within twelve months of patient registration
- NCCN risk category very low, low, or intermediate risk
- Combined Gleason score <7
- PSA within three months of enrollment < 20ng/ml
- Clinical stage T1a-c N0M0 or clinical stage T2aN0M0
Key exclusion criteria (7 listed)
- History of inflammatory bowel disease
- Prior radical prostate surgery, transurethral resection of the prostate(TURP), or prostate cryotherapy
- Patients using immunosuppressive medications or other medications that may increase radiation toxicity such as methotrexate, sirolimus, tacrolimus, or colchicine that are unable to discontinue these medications during SBRT course. Use of corticosteroids are not considered an exclusion criteria.
- Platelet count < 70
- Patients unable to discontinue anti-platelet or anti-coagulant medicine such as clopidogrel, dabigatran, warfarin, or low molecular weight heparin. Use of aspirin is not an exclusion criteria.
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 |
|---|---|---|
| Stereotactic Body Radiation Therapy with Integrated BoostAlso: SBRT, IMRT, VMATSBRT with Integrated boost at 7.25 Gy and 8.00 Gy per fraction for five fractions | Radiation | Stereotactic Body Radiation Therapy with Integrated Boost |
Primary outcome
Number of Patients Who Experienced Early Toxicity of SBRT With Integrated Boost for Localized Prostate Cancer
Time frame: Within 3 months of the completion of radiation therapy
Early toxicity (defined as events occurring within 90 days of therapy) will be assessed by physician history and physical exams and patient toxicity/quality-of-life questionnaires to be administered at regular intervals.
4 secondary outcomes
Treatment Planning Feasibility
Time frame: Within 6 months of completion of radiation therapy
Early Efficacy
Time frame: Within 6 months of completion of radiation therapy
Number of Patients Who Experienced Late Toxicity
Time frame: Within 6 months of completion of radiation therapy
Median Quality of Life Score
Time frame: Within 6 months of completion of radiation therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- 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.
John B Fiveash, MD principal investigator
University of Alabama at Birmingham Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Body Radiation Therapy with Integrated Boost in people with Prostate Cancer and Prostate Adenocarcinoma, run by John Fiveash, MD 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 10 inclusion and 7 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 12 Jan 2023. 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 12 Jan 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?
Number of Patients Who Experienced Early Toxicity of SBRT With Integrated Boost for Localized Prostate Cancer (time frame: Within 3 months of the completion of radiation therapy). 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 12 Jan 2023.