Prostate CancerNCT00407875
Intensity Modulated Versus Interstitial - Radiation Therapy
A study testing Intensity Modulated External Beam Radiation Therapy in people with Prostate Cancer, run by British Columbia Cancer Agency at 1 site in Canada.
Trial summary
Purpose: The purpose of this trial is to compare two different treatment options for patients with low risk and low-tier intermediate risk prostate cancer. The two treatment arms being compared in this study are: (control arm) permanent interstitial prostate brachytherapy (PIPB) VERSUS (experimental arm) intensity… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Intensity Modulated External Beam Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2007to Mar 2020
- 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 20 weeks of biopsy.
- History and physical examination within 8 weeks prior to randomization.
- Patients must have either low risk or low-tier intermediate risk prostate cancer (Low risk must have all of: clinical stage <= T2b, Gleason score <= 6, and initial PSA <= 10; Low-tier intermediate risk must have: clinical stage <= T2c, < 50% positive biopsy cores, AND EITHER Gleason score = 7 and initial PSA <= 10 OR Gleason score <= 6 and initial PSA > 10 and <= 15.)
- Patients must have a ECG, PSA, TTT, CBC, electrolytes, Cr, INR, PTT, and random glucose within 2 weeks of registration.
- Patients must be fit for general or spinal anesthetic.
Show all 19Show fewer
- Patients must have an estimated life expectancy of at least 10 years.
- Patients must have an ECOG performance status of 0 - 2.
- Patients must have no contraindications for high dose pelvic irradiation or transperineal interstitial brachytherapy.
- 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 prostate volumes < 60 cm3 on transrectal ultrasound.
- Patients must not have received prior surgical treatment for prostate cancer including TURP, TURB, cryotherapy, laser ablation or microwave therapy.
- Patients on coumadin therapy must be able to stop therapy safely for at least 12 days.
- Patients must have an International Prostate Symptom Score (IPSS) of less than 20.
- Patients must have no history of previous malignancies, except non-melanoma skin tumors.
- Patients must have a body mass index (BMI) of <= 32.
Who cannot join
- Those patients who do not meet the inclusion criteria described above will be excluded from participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Phase II Study Comparing Intensity Modulated External Beam Radiation Therapy (IMRT) Versus Permanent Interstitial Prostate Brachytherapy (PIPB) for Low Risk and Low-tier Intermediate Risk Prostate Cancer
Purpose:
The purpose of this trial is to compare two different treatment options for patients with low risk and low-tier intermediate risk prostate cancer. The two treatment arms being compared in this study are: (control arm) permanent interstitial prostate brachytherapy (PIPB) VERSUS (experimental arm) intensity modulated external beam radiation therapy (IMRT).
Hypothesis:
The acute and late toxicities experienced by patients in the experimental arm (IMRT) are not significantly worse then the toxicities experienced by patients in the control arm (PIPB).
Read the detailed description
Justification:
Patients with low risk and low-tier intermediate risk prostate cancer have a number of different standard treatment options to chose from that include a radical prostatectomy, conventional external beam radiotherapy (EBRT), or permanent interstitial prostate brachytherapy (PIPB). Each of these treatment options have good outcomes, although they are known to have a small risk of complications associated with each of them. Unfortunately, these treatment options have never been directly compared and therefore it is difficult to determine how these treatment options compare with respect to overall outcomes and toxicity.
A recent analysis from the BC Cancer Agency suggested that patients treated with conventional EBRT within the Agency had inferior outcomes compared to PIPB. This data, as well as other indirect evidence, suggest that conventional EBRT may be a suboptimal treatment option compared to PIPB. Intensity modulated external beam radiotherapy (IMRT) is a new technology that allows for the delivery of high doses of radiation that tightly conforms to the target and limits the dose to surrounding critical structures. Although IMRT is currently a standard therapeutic option that is utilized in other cancer sites at the BC Cancer Agency, it has not been utilized in prostate cancer yet. Recent evidence has confirmed that this experimental therapy is able to allow for the safe escalation of dose for prostate cancer patients, which may lead to improved outcomes, without increasing toxicity. There is no current evidence that side effects and complication risks associated with IMRT are associated with any serious risk of increased toxicity, although this continues to be studied.
This study will compare this new therapeutic approach (IMRT) directly with a standard treatment option for prostate cancer patients (PIPB). This trial will allow us to determine how the toxicities of these treatments compare with each other and, if successful, will potentially lead to a larger study which will analyse how the outcomes of these therapeutic interventions compare. We hope that this trial will make an important contribution to the care and future management of patients with prostate cancer.
Objectives:
Primary Objective:
The primary end point of this study is the acute and late toxicities of the therapeutic interventions.
Secondary Objectives:
This trial is also intended to determine:
- The willingness of eligible patients to be randomized to the treatment interventions.
- Obstacles to accrual that need to be addressed.
- Testing our ability to meet accrual targets.
- Checking quality assurance benchmarks for IMRT and PIPB procedures.
- Discovering and relieving bottlenecks in IMRT planning and procedures.
- Quality of life.
- Pathological local control.
- Biochemical relapse-free survival.
- Metastasis-free survival.
- Overall survival.
Research Method:
The patients will be randomly assigned with equal probability to one of two treatment arms:
Arm 1 (Control Arm) - Permanent interstitial prostate brachytherapy (PIPB). Arm 2 (Experimental Arm) - Intensity modulated external beam radiation therapy (IMRT).
Statistical Analysis:
Primary Endpoints:
Acute GI grade 3 or higher toxicity. Acute GU grade 3 or higher toxicity. Late GI grade 3 or higher toxicity. Late GU grade 3 or higher toxicity.
Secondary Endpoints:
All acute and late toxicities. Quality of life scores (Using the expanded prostate cancer index composite - EPIC).
Pathological local control. Biochemical relapse-free survival (using Phoenix definition). Metastasis-free survival. Overall survival.
Planned sample size: 50 patients in total (i.e. 25 patients in each treatment arm).
Statistical analysis:
The two groups will be compared with respect to their primary and secondary endpoints. Appropriate statistical analysis using a student t test for a statistical difference in crude rates of grade 3 or higher toxicity between the two treatment arms will be performed. All endpoints will be analysed for crude event rates with 95% confidence intervals for each group.
With a sample size of only 50 patients, this trial is not powered to detect differences in the incidence of common self-limited side effects and adverse reactions compared to standard therapy. For this reason, the trial's limited power is augmented by a Trial Safety Committee (TSC) which is bound by rules that require suspension/ termination of trial accrual in the event of major complications (See Section 8.3 of Data Monitoring - Human Ethics Application for Clinical Study or Part I: Section 5.3 on page 11 of the protocol).
- Conditions
- Prostate Cancer
- Being tested
- Intensity Modulated External Beam Radiation Therapy
- Keywords
- Prostate, Cancer, 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.
Intensity Modulated External Beam Radiation TherapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Permanent interstitial prostate brachytherapy (PIPB) | Active comparator | patient will undergo permanent interstitial prostate brachytherapy (PIPB) using a transperineal approach to deliver 125Iodine Rapidstrand® seeds at the facilities of the British Columbia Cancer Agency (BCCA) by one or more of the certified prostate brachytherapists in the BCCA Prostate Brachytherapy Program. The minimum peripheral dose (MPD) to the prostate gland of the implant will be 144 Gy as per TG 43 protocol. A modified peripheral loading technique will be utilized in an effort to maintain the periurethral dose to < 150% of the MPD. Within 48 hours of the implant, the patient will undergo a day 0 CT scan of the pelvis to assess post implant dosimetry using the standard BCCA protocol. Receives: Procedure: Intensity Modulated External Beam Radiation Therapy |
| Intensity modulated external beam radiation therapy (IMRT) | Experimental | patient will undergo a course of intensity modulated external beam radiation therapy (IMRT) to a volume encompassing the prostate gland. The total radiation dose will be 70 Gy delivered in 28 fractions, so that the minimum dose to the PTV is 70 Gy, with CT simulation used for planning the treatment. Prior to starting the course of IMRT, fiducial markers will be placed in the prostate to assist in localization of the prostate for planning and quality assurance during treatment. Receives: Procedure: Intensity Modulated External Beam Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end point of this study is the acute and late toxicities of the therapeutic interventions.
Measured: Through study completion. Approximately 5 years.
Secondary outcomes (9)
The willingness of eligible patients to be randomized to the treatment interventions.
Measured: 1 year
Obstacles to accrual that need to be addressed.
Measured: 1 year
Testing our ability to meet accrual targets.
Measured: 1 year
Checking quality assurance benchmarks for IMRT and PIPB procedures.
Measured: 1 year
Quality of life based on urinary function, bowel habits, sexual function, and hormonal function
Measured: Assessed at 6 weeks, 6, 9, 12, 18, 24 ,30, 36 months. Then annually until end of participation
Pathological local control.
Measured: Assessed at 28 months
Biochemical relapse-free survival.
Measured: Assessed at every clinic visit and every 6 months
Metastasis-free survival.
Measured: Assessed at every clinic visit until end of participation. Approximately 10 years.
Overall survival.
Measured: Assessed at every clinic visit until end of participation. Approximately 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2006 (estimated)
- Study startMar 2007
- Primary completionMar 2008
- Study completionMar 2020 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
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
- NCT00407875
- Sponsor's protocol ID
- IMVI-RT
- Status last verified
- Jul 2018
- First submitted
- 1 Dec 2006
- Last updated
- 13 Jul 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study Comparing Intensity Modulated External Beam Radiation Therapy (IMRT) Versus Permanent Interstitial Prostate Brachytherapy (PIPB) for Low Risk and Low-tier Intermediate Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT00407875
- Acronym / sponsor ID
- IMVI-RT
- Conditions
- Prostate Cancer
- Keywords
- Prostate, Cancer, Radiation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2020 (estimated)
- First posted
- 5 Dec 2006 (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.
Purpose:
The purpose of this trial is to compare two different treatment options for patients with low risk and low-tier intermediate risk prostate cancer. The two treatment arms being compared in this study are: (control arm) permanent interstitial prostate brachytherapy (PIPB) VERSUS (experimental arm) intensity modulated external beam radiation therapy (IMRT).
Hypothesis:
The acute and late toxicities experienced by patients in the experimental arm (IMRT) are not significantly worse then the toxicities experienced by patients in the control arm (PIPB).
Detailed description
Justification:
Patients with low risk and low-tier intermediate risk prostate cancer have a number of different standard treatment options to chose from that include a radical prostatectomy, conventional external beam radiotherapy (EBRT), or permanent interstitial prostate brachytherapy (PIPB). Each of these treatment options have good outcomes, although they are known to have a small risk of complications associated with each of them. Unfortunately, these treatment options have never been directly compared and therefore it is difficult to determine how these treatment options compare with respect to overall outcomes and toxicity.
A recent analysis from the BC Cancer Agency suggested that patients treated with conventional EBRT within the Agency had inferior outcomes compared to PIPB. This data, as well as other indirect evidence, suggest that conventional EBRT may be a suboptimal treatment option compared to PIPB. Intensity modulated external beam radiotherapy (IMRT) is a new technology that allows for the delivery of high doses of radiation that tightly conforms to the target and limits the dose to surrounding critical structures. Although IMRT is currently a standard therapeutic option that is utilized in other cancer sites at the BC Cancer Agency, it has not been utilized in prostate cancer yet. Recent evidence has confirmed that this experimental therapy is able to allow for the safe escalation of dose for prostate cancer patients, which may lead to improved outcomes, without increasing toxicity. There is no current evidence that side effects and complication risks associated with IMRT are associated with any serious risk of increased toxicity, although this continues to be studied.
This study will compare this new therapeutic approach (IMRT) directly with a standard treatment option for prostate cancer patients (PIPB). This trial will allow us to determine how the toxicities of these treatments compare with each other and, if successful, will potentially lead to a larger study which will analyse how the outcomes of these therapeutic interventions compare. We hope that this trial will make an important contribution to the care and future management of patients with prostate cancer.
Objectives:
Primary Objective:
The primary end point of this study is the acute and late toxicities of the therapeutic interventions.
Secondary Objectives:
This trial is also intended to determine:
- The willingness of eligible patients to be randomized to the treatment interventions.
- Obstacles to accrual that need to be addressed.
- Testing our ability to meet accrual targets.
- Checking quality assurance benchmarks for IMRT and PIPB procedures.
- Discovering and relieving bottlenecks in IMRT planning and procedures.
- Quality of life.
- Pathological local control.
- Biochemical relapse-free survival.
- Metastasis-free survival.
- Overall survival.
Research Method:
The patients will be randomly assigned with equal probability to one of two treatment arms:
Arm 1 (Control Arm) - Permanent interstitial prostate brachytherapy (PIPB). Arm 2 (Experimental Arm) - Intensity modulated external beam radiation therapy (IMRT).
Statistical Analysis:
Primary Endpoints:
Acute GI grade 3 or higher toxicity. Acute GU grade 3 or higher toxicity. Late GI grade 3 or higher toxicity. Late GU grade 3 or higher toxicity.
Secondary Endpoints:
All acute and late toxicities. Quality of life scores (Using the expanded prostate cancer index composite - EPIC).
Pathological local control. Biochemical relapse-free survival (using Phoenix definition). Metastasis-free survival. Overall survival.
Planned sample size: 50 patients in total (i.e. 25 patients in each treatment arm).
Statistical analysis:
The two groups will be compared with respect to their primary and secondary endpoints. Appropriate statistical analysis using a student t test for a statistical difference in crude rates of grade 3 or higher toxicity between the two treatment arms will be performed. All endpoints will be analysed for crude event rates with 95% confidence intervals for each group.
With a sample size of only 50 patients, this trial is not powered to detect differences in the incidence of common self-limited side effects and adverse reactions compared to standard therapy. For this reason, the trial's limited power is augmented by a Trial Safety Committee (TSC) which is bound by rules that require suspension/ termination of trial accrual in the event of major complications (See Section 8.3 of Data Monitoring - Human Ethics Application for Clinical Study or Part I: Section 5.3 on page 11 of the protocol).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Permanent interstitial prostate brachytherapy (PIPB) | Active comparator | Procedure: Intensity Modulated External Beam Radiation Therapypatient will undergo permanent interstitial prostate brachytherapy (PIPB) using a transperineal approach to deliver 125Iodine Rapidstrand® seeds at the facilities of the British Columbia Cancer Agency (BCCA) by one or more of the certified prostate brachytherapists in the BCCA Prostate Brachytherapy Program. The minimum peripheral dose (MPD) to the prostate gland of the implant will be 144 Gy as per TG 43 protocol. A modified peripheral loading technique will be utilized in an effort to maintain the periurethral dose to < 150% of the MPD. Within 48 hours of the implant, the patient will undergo a day 0 CT scan of the pelvis to assess post implant dosimetry using the standard BCCA protocol. |
| Intensity modulated external beam radiation therapy (IMRT) | Experimental | Procedure: Intensity Modulated External Beam Radiation Therapypatient will undergo a course of intensity modulated external beam radiation therapy (IMRT) to a volume encompassing the prostate gland. The total radiation dose will be 70 Gy delivered in 28 fractions, so that the minimum dose to the PTV is 70 Gy, with CT simulation used for planning the treatment. Prior to starting the course of IMRT, fiducial markers will be placed in the prostate to assist in localization of the prostate for planning and quality assurance during treatment. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- Patients must have histologically proven adenocarcinoma of the prostate.
- Registration must occur within 20 weeks of biopsy.
- History and physical examination within 8 weeks prior to randomization.
- Patients must have either low risk or low-tier intermediate risk prostate cancer (Low risk must have all of: clinical stage <= T2b, Gleason score <= 6, and initial PSA <= 10; Low-tier intermediate risk must have: clinical stage <= T2c, < 50% positive biopsy cores, AND EITHER Gleason score = 7 and initial PSA <= 10 OR Gleason score <= 6 and initial PSA > 10 and <= 15.)
- Patients must have a ECG, PSA, TTT, CBC, electrolytes, Cr, INR, PTT, and random glucose within 2 weeks of registration.
Key exclusion criteria (1 listed)
- Those patients who do not meet the inclusion criteria described above will be excluded from participation.
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 |
|---|---|---|
| Intensity Modulated External Beam Radiation Therapy | Procedure or surgery | Intensity modulated external beam radiation therapy (IMRT), Permanent interstitial prostate brachytherapy (PIPB) |
Primary outcome
The primary end point of this study is the acute and late toxicities of the therapeutic interventions.
Time frame: Through study completion. Approximately 5 years.
9 secondary outcomes
The willingness of eligible patients to be randomized to the treatment interventions.
Time frame: 1 year
Obstacles to accrual that need to be addressed.
Time frame: 1 year
Testing our ability to meet accrual targets.
Time frame: 1 year
Checking quality assurance benchmarks for IMRT and PIPB procedures.
Time frame: 1 year
Quality of life based on urinary function, bowel habits, sexual function, and hormonal function
Time frame: Assessed at 6 weeks, 6, 9, 12, 18, 24 ,30, 36 months. Then annually until end of participation
Pathological local control.
Time frame: Assessed at 28 months
Biochemical relapse-free survival.
Time frame: Assessed at every clinic visit and every 6 months
Metastasis-free survival.
Time frame: Assessed at every clinic visit until end of participation. Approximately 10 years.
Overall survival.
Time frame: Assessed at every clinic visit until end of participation. Approximately 10 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 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 Intensity Modulated External Beam Radiation Therapy 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 19 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: status not confirmed, as of the sponsor's last update on 13 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?
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?
The primary end point of this study is the acute and late toxicities of the therapeutic interventions. (time frame: Through study completion. Approximately 5 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 13 Jul 2018.