Prostate CancerNCT00798837
Intraprostatic MAXimal Simultaneous Boost
A study testing Intraprostatic maximal simultaneous boost in people with Prostate Cancer, run by British Columbia Cancer Agency at 1 site in Canada.
Trial summary
This trial uses a type of radiotherapy called intensity modulated radiotherapy (IMRT), which is able to deliver the radiation to the prostate while delivering less dose to the surrounding normal organs compared with standard 3D conformal radiotherapy presently used at the BCCA. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Intraprostatic maximal simultaneous boost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2008to Oct 2016
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have histologically proven adenocarcinoma of the prostate.
- Registration must occur within 26 weeks of biopsy.
- History and physical examination (including digital rectal examination (DRE)) within 8 weeks prior to registration.
- Patients must have intermediate risk prostate cancer, as defined by:
- PSA ≤ 20 ng/ml,
- Gleason ≤ 7,
Show all 21Show fewer
- Stage ≤ T2c, and
- Do not meet criteria for low-risk prostate cancer (Low-risk = All of: PSA ≤ 10 + Gleason ≤ 6 + stage ≤ T2b)
- Patients must have the following blood tests within two weeks of registration:
- Prostate specific antigen (PSA), testosterone (TTT), complete blood count (CBC), electrolytes, creatinine.
- Patients with values for one or more of these tests (not including PSA) that fall outside the normal range will need to be reviewed by the oncologist to determine their eligibility for this study.
- Patients must have an estimated life expectancy of at least 10 years.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.
- Patients must have no contraindications to high dose pelvic irradiation.
- Patients must not have received prior radiation therapy to the pelvis.
- Patients must have no history of inflammatory bowel disease.
- Patients must not have received prior hormonal therapy or chemotherapy.
- Patients must not have any hormonal therapy planned as part of the therapeutic intervention.
- Patients must have no contraindication to MRI scanning.
- Patients should not have an artificial hip
- Patients should not have a body mass index (BMI) of > 32. Note: BMI = weight in kg ÷ (height in metres)2
Who cannot join
- 1. Subjects that do not meet inclusion criteria.
Trial locations and contacts
1 site in 1 country.
Canada1 site
British Columbia Cancer Agency - Vancouver Centre
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: A Dose-escalation Study Using a Maximal Simultaneous Intraprostatic Boost With RapidArc Intensity Modulated Radiotherapy in Intermediate Risk Prostate Cancer
This trial uses a type of radiotherapy called intensity modulated radiotherapy (IMRT), which is able to deliver the radiation to the prostate while delivering less dose to the surrounding normal organs compared with standard 3D conformal radiotherapy presently used at the BCCA. This trial will use RapidArc IMRT, which is a new way of delivering IMRT, where the radiation dose is delivered in a single rotation of the radiotherapy machine around the patient. This new method of delivering IMRT has been shown to be at least as good as conventional IMRT at delivering the dose, and takes less time to do so.
The aim of this study is to deliver a higher radiation dose to the prostate gland than the standard treatment while not increasing dose to the normal organs. In this way, it is hoped that the likelihood of the cancer coming back will be reduced without causing an increase in side-effects.
- Conditions
- Prostate Cancer
- Being tested
- Intraprostatic maximal simultaneous boost
- Keywords
- prostate, cancer, IMRT, radiation
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraprostatic maximal simultaneous boostRadiation
Each patient will undergo a course of intensity modulated external beam radiation therapy (IMRT) using RapidArc for optimization and delivery.
Doses of radiotherapy are as follows:
- The prescription dose will be 73.7 Gy in 28 fractions
- A simultaneous intraprostatic boost will be given to as much of the CTV as possible without contravening OAR dose constraints.
| Study group | Role | What they receive |
|---|---|---|
| IMAX | Other | There is only one arm in this study.
Each patient will undergo a course of intensity modulated external beam radiation therapy (IMRT) using RapidArc for optimization and delivery.
Doses of radiotherapy are as follows:
* The prescription dose will be 73.7 Gy in 28 fractions.
* A simultaneous intraprostatic maximal simultaneous boost will be given to as much of the CTV as possible without contravening OAR dose constraints. Receives: Radiation: Intraprostatic maximal simultaneous boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade 2-4 gastrointestinal and genitourinary toxicity
Measured: No time frame (post-treatment)
Secondary outcomes (5)
Quality of life (EPIC, IPSS and SHIM questionnaires)
Measured: Post-treatment; every 6 mos until 5 years - then annual
Percentage of CTV treated to boost dose
Measured: Immediately post-treatment
Time-cost analysis compared to external-beam radiotherapy with brachytherapy boost
Measured: No time frame
Accuracy of surrogate urethra compared to T2-MRI localization
Measured: No time frame
Quantification of dose received by lesions identified by diffusion-weighted and dynamic contrast enhanced MRI
Measured: No time frame
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: Excess risk in rectal bleeding of first 10 patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Morris, British Columbia Cancer Agency
- Investigators
- William J Morris, MD, Principal investigator, British Columbia Cancer Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798837
- Sponsor's protocol ID
- IMAX
- Status last verified
- Jul 2018
- First submitted
- 24 Nov 2008
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-escalation Study Using a Maximal Simultaneous Intraprostatic Boost With RapidArc Intensity Modulated Radiotherapy in Intermediate Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT00798837
- Acronym / sponsor ID
- IMAX
- Conditions
- Prostate Cancer
- Keywords
- prostate, cancer, IMRT, radiation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Excess risk in rectal bleeding of first 10 patients
- Enrolment
- 10 participants (actual)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 26 Nov 2008 (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 trial uses a type of radiotherapy called intensity modulated radiotherapy (IMRT), which is able to deliver the radiation to the prostate while delivering less dose to the surrounding normal organs compared with standard 3D conformal radiotherapy presently used at the BCCA. This trial will use RapidArc IMRT, which is a new way of delivering IMRT, where the radiation dose is delivered in a single rotation of the radiotherapy machine around the patient. This new method of delivering IMRT has been shown to be at least as good as conventional IMRT at delivering the dose, and takes less time to do so.
The aim of this study is to deliver a higher radiation dose to the prostate gland than the standard treatment while not increasing dose to the normal organs. In this way, it is hoped that the likelihood of the cancer coming back will be reduced without causing an increase in side-effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMAX | Other | Radiation: Intraprostatic maximal simultaneous boostThere is only one arm in this study. Each patient will undergo a course of intensity modulated external beam radiation therapy (IMRT) using RapidArc for optimization and delivery. Doses of radiotherapy are as follows: * The prescription dose will be 73.7 Gy in 28 fractions. * A simultaneous intraprostatic maximal simultaneous boost will be given to as much of the CTV as possible without contravening OAR dose constraints. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (21 listed)
- Patients must have histologically proven adenocarcinoma of the prostate.
- Registration must occur within 26 weeks of biopsy.
- History and physical examination (including digital rectal examination (DRE)) within 8 weeks prior to registration.
- Patients must have intermediate risk prostate cancer, as defined by:
- Patients must have the following blood tests within two weeks of registration:
Key exclusion criteria (1 listed)
- 1. Subjects that do not meet inclusion 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 |
|---|---|---|
| Intraprostatic maximal simultaneous boostEach patient will undergo a course of intensity modulated external beam radiation therapy (IMRT) using RapidArc for optimization and delivery. Doses of radiotherapy are as follows: * The prescription dose will be 73.7 Gy in 28 fractions * A simultaneous intraprostatic boost will be given to as much of the CTV as possible without contravening OAR dose constraints. | Radiation | IMAX |
Primary outcome
Incidence of grade 2-4 gastrointestinal and genitourinary toxicity
Time frame: No time frame (post-treatment)
5 secondary outcomes
Quality of life (EPIC, IPSS and SHIM questionnaires)
Time frame: Post-treatment; every 6 mos until 5 years - then annual
Percentage of CTV treated to boost dose
Time frame: Immediately post-treatment
Time-cost analysis compared to external-beam radiotherapy with brachytherapy boost
Time frame: No time frame
Accuracy of surrogate urethra compared to T2-MRI localization
Time frame: No time frame
Quantification of dose received by lesions identified by diffusion-weighted and dynamic contrast enhanced MRI
Time frame: No time frame
Results and safety
The study was stopped early (reason given: Excess risk in rectal bleeding of first 10 patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
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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.
William J Morris, MD principal investigator
British Columbia Cancer Agency
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraprostatic maximal simultaneous boost in people with Prostate Cancer, run by British Columbia Cancer Agency at 1 site in Canada.
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 21 inclusion and 1 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 11 Jul 2018. 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 Canada. 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: Excess risk in rectal bleeding of first 10 patients). 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?
Incidence of grade 2-4 gastrointestinal and genitourinary toxicity (time frame: No time frame (post-treatment)). 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 11 Jul 2018.