Prostate AdenocarcinomaNCT01737151
Stereotactic Body Radiation Therapy in Treating Patients With Low- and Intermediate-Risk Prostate Cancer
A study testing stereotactic body radiation therapy and four fraction split-course SBRT in people with Prostate Adenocarcinoma and Stage I Prostate Cancer, run by Virginia Commonwealth University at 3 sites in United States.
Trial summary
This clinical trial studies stereotactic body radiation therapy in treating patients with low- and intermediate-risk prostate cancer. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Adenocarcinoma, Stage I Prostate Cancer
- What is being tested?
- stereotactic body radiation therapy and four fraction split-course SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Mar 2013to 9 Nov 2017
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have low or intermediate risk adenocarcinoma of the prostate as defined by:
- Low-risk disease - Histopathology score (Gleason sum): =<6, T-stage (per current AJCC staging criteria): T1c-T2a, and PSA: <10
- Intermediate-risk disease as either:
- Histopathology score (Gleason sum) =< 6, T-stage (per current American Joint Committee on Cancer [AJCC] staging criteria): T1c-T2a, and prostate-specific antigen (PSA) > 10 but =< 20; or
- Histopathology score (Gleason sum) 7 with =< 50% of any cores positive, T-stage (per current AJCC staging criteria): T1c-T2a, and PSA < 10
- Charlson index of comorbidity score =< 4
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Patients with history of inflammatory bowel disease, or who require steroid or cytotoxic therapy for collagen vascular disease
- Patients with a history of cancer other than skin cancer within 5 years of the initiation of protocol treatment
- Patients with a history of pelvic irradiation for any reason
- Life expectancy < 10 years - Prior treatment with an anti-androgen, luteinizing hormone-releasing hormone (LHRH) agonist, or a combination of the two
- Prior radiation therapy, brachytherapy, or cryotherapy
- Prior surgical procedure involving peri-rectal and peri-prostatic area
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Virginia Medical Center
Charlottesville, Virginia, 22908
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
About this study
Official title: Study of 4-Fraction Split-Course Stereotactic Ablative Radiation Therapy of the Treatment of Patients With Low and Intermediate Risk Adenocarcinoma of the Prostate
This clinical trial studies stereotactic body radiation therapy in treating patients with low- and intermediate-risk prostate cancer. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate, in terms of late toxicity, the safety of stereotactic radiation therapy using the proposed fractionation schedule.
SECONDARY OBJECTIVES:
- To evaluate, in terms of acute toxicity, the safety of stereotactic radiation therapy using the proposed fractionation schedule.
II. To determine stereotactic treatment efficacy through biochemical failure (Phoenix criteria).
III. To determine the protocol completion rate. IV. To describe patient-reported outcomes using International Index of Erectile Function (IIEF) and EPIC Urinary and Bowel Assessment questionnaires.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo standard daily fractions of stereotactic body radiation therapy (SBRT) over 7-8.5 weeks.
- Conditions
- Prostate Adenocarcinoma, Stage I Prostate Cancer
- Being tested
- stereotactic body radiation therapy, four fraction split-course SBRT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stereotactic body radiation therapyRadiation
Also called SBRT, stereotactic radiation therapy, stereotactic radiotherapy
Undergo SBRT
four fraction split-course SBRTRadiation
four fraction split-course SBRT
| Study group | Role | What they receive |
|---|---|---|
| Arm I (standard stereotactic body radiation therapy (SBRT) | Active comparator | Patients undergo standard daily fractions of SBRT over 7-8.5 weeks Receives: Radiation: stereotactic body radiation therapy |
| Arm II (four fraction split-course SBRT) | Experimental | Patients undergo 2 fractions of SBRT in weeks 1 and 4 Receives: Radiation: four fraction split-course SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late toxicity greater than or equal to grade 2 as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria
Will be tested using a continuity corrected chi-square test
Measured: 2 years
Secondary outcomes (4)
Biochemical failure as defined by the Phoenix definition
Measured: Up to 5 years
Protocol completion rate
The portion of patients completing the planned protocol with no unacceptable protocol violations is anticipated to be greater than 90%. A completion rate of 70% is deemed unacceptably low.
Measured: Up to 5 years
Patient-reported outcomes
International Index of Erectile Function (IIEF) and Expanded Prostate Cancer Index Composite urinary Assessment (EPIC) urinary and bowel assessments will be used to collect patient-reported outcomes.
- IIEF is a widely used instrument for the evaluation of male sexual function. It is has been recommended as tool for clinical trials of erectile dysfunction and for diagnostic evaluation of erectile dysfunction severity. 15 questions 1=very low (worst) to 5=very high (best).
- The EPIC urinary and bowel assessments are comprehensive instruments designed to evaluate urinary and bowel symptoms, thereby providing a unique tool for assessment of quality of life issues important in prostate cancer management. 9 questions 0=no problem to 5=big problem
Measured: Up to 5 years
Acute toxicity greater than or equal to grade 2 as defined by the CTCAE version 4 criteria
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study start8 Mar 2013
- Primary completion9 Nov 2017
- Study completion9 Nov 2017
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy J Harris, M.D., Principal investigator, Massey Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737151
- Sponsor's protocol ID
- MCC-14712
- Other IDs
- NCI-2012-02545
- Status last verified
- Aug 2019
- First submitted
- 26 Nov 2012
- Last updated
- 3 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of 4-Fraction Split-Course Stereotactic Ablative Radiation Therapy of the Treatment of Patients With Low and Intermediate Risk Adenocarcinoma of the Prostate
- ClinicalTrials.gov ID
- NCT01737151
- Acronym / sponsor ID
- MCC-14712
- Conditions
- Prostate Adenocarcinoma, Stage I Prostate Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 8 Mar 2013
- Primary completion
- 9 Nov 2017 (actual)
- Study completion
- 9 Nov 2017 (actual)
- First posted
- 29 Nov 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.
This clinical trial studies stereotactic body radiation therapy in treating patients with low- and intermediate-risk prostate cancer. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate, in terms of late toxicity, the safety of stereotactic radiation therapy using the proposed fractionation schedule.
SECONDARY OBJECTIVES:
- To evaluate, in terms of acute toxicity, the safety of stereotactic radiation therapy using the proposed fractionation schedule.
II. To determine stereotactic treatment efficacy through biochemical failure (Phoenix criteria).
III. To determine the protocol completion rate. IV. To describe patient-reported outcomes using International Index of Erectile Function (IIEF) and EPIC Urinary and Bowel Assessment questionnaires.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo standard daily fractions of stereotactic body radiation therapy (SBRT) over 7-8.5 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (standard stereotactic body radiation therapy (SBRT) | Active comparator | Radiation: stereotactic body radiation therapyPatients undergo standard daily fractions of SBRT over 7-8.5 weeks |
| Arm II (four fraction split-course SBRT) | Experimental | Radiation: four fraction split-course SBRTPatients undergo 2 fractions of SBRT in weeks 1 and 4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must have low or intermediate risk adenocarcinoma of the prostate as defined by:
- Charlson index of comorbidity score =< 4
- Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (6 listed)
- Patients with history of inflammatory bowel disease, or who require steroid or cytotoxic therapy for collagen vascular disease
- Patients with a history of cancer other than skin cancer within 5 years of the initiation of protocol treatment
- Patients with a history of pelvic irradiation for any reason
- Life expectancy < 10 years - Prior treatment with an anti-androgen, luteinizing hormone-releasing hormone (LHRH) agonist, or a combination of the two
- Prior radiation therapy, brachytherapy, or cryotherapy
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 therapyAlso: SBRT, stereotactic radiation therapy, stereotactic radiotherapyUndergo SBRT | Radiation | Arm I (standard stereotactic body radiation therapy (SBRT) |
| four fraction split-course SBRTfour fraction split-course SBRT | Radiation | Arm II (four fraction split-course SBRT) |
Primary outcome
Late toxicity greater than or equal to grade 2 as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria
Time frame: 2 years
Will be tested using a continuity corrected chi-square test
4 secondary outcomes
Biochemical failure as defined by the Phoenix definition
Time frame: Up to 5 years
Protocol completion rate
Time frame: Up to 5 years
Patient-reported outcomes
Time frame: Up to 5 years
Acute toxicity greater than or equal to grade 2 as defined by the CTCAE version 4 criteria
Time frame: Up to 90 days
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2019.
Related trials for Prostate Adenocarcinoma
RecruitingPhase 2
Multitargeted Recombinant Ad5 PSA/MUC-1/Brachyury-Based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance
Adenocarcinoma, Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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.
Timothy J Harris, M.D. principal investigator
Massey Cancer Center
3 sites 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 and four fraction split-course SBRT in people with Prostate Adenocarcinoma and Stage I Prostate Cancer, run by Virginia Commonwealth University at 3 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 7 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: stopped early, as of the sponsor's last update on 3 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
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?
Late toxicity greater than or equal to grade 2 as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria (time frame: 2 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 Sep 2019.