Prostate CancerPhase 2NCT01704027
Safety Study of Pelvic and Prostatic SIB-IMRT With Long-term Androgen Deprivation for High Risk Localized Prostate Cancer
A Phase 2 study testing Simultaneous integrated boost intensity-modulated arctherapy and Androgen deprivation in people with Prostate Cancer, run by Centre Georges Francois Leclerc at 1 site in France.
Trial summary
The purpose of this study is to evaluate the incidence of urinary and rectal acute side effects of a pelvic and prostatic intensity-modulated arctherapy with simultaneous integrated boost (SIB-IMRT)combined with long-term androgen deprivation for patients with high risk localized prostate cancer Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Simultaneous integrated boost intensity-modulated arctherapy and Androgen deprivation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2012to Mar 2014
- Phase
- Phase 2
- 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 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of the prostate
- High risk localized adenocarcinoma defined by at least one of the following criteria:
- Clinical stage T2c, T3 or T4
- Gleason score ≥ 8
- Prostate-specific antigen (PSA)≥ 20 ng/ml and ≤ 100 ng/ml
- Patient cN0, pN0 or Nx (negative lymphadenectomy or no lymphadenectomy)
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- No pelvic adenopathy ≥ 15 mm on CT or MRI,
- Absence of bone and/or visceral metastasis
- Androgen deprivation beginning no later than the day of radiotherapy and up to six months before irradiation
- Absence of prior pelvic radiotherapy,
- Absence of surgical treatment of prostate cancer except transurethral resection performed within 4 months minimum before radiotherapy,
- Age ≥ 18 years and ≤ 85 years
- ECOG performance status ≤ 1,
- Estimated life expectancy > 5 years
- Membership of a social security system,
- Signed informed consent.
Who cannot join
- Prostate cancer histology other than adenocarcinoma,
- pN1 patients (lymph node dissection after histologically proven)
- PSA > 100 ng/ml
- History of cancer within 5 years prior to trial entry (with the exception of basal cell carcinoma skin)
- Patient with severe hypertension uncontrolled by appropriate treatment (≥ 160 mm Hg systolic and / or ≥ 90 mm Hg diastolic)
- Contra-indication for pelvic irradiation (eg scleroderma, chronic inflammatory disease of the digestive tract, etc ...)
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- Contra-indication to agonists or antagonists of LH-RH
- Bilateral hip prosthesis,
- Patients already included in another clinical trial with an experimental molecule,
- Persons deprived of liberty or under guardianship
- Unable to undergo medical test for geographical, social or psychological.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Phase II Study Evaluating the Feasibility of a Conformational Pelvic and Prostatic Radiotherapy With Simultaneous Integrated Boost Modulated-intensity Arctherapy (SIB-IMAT) in Combination With Long Term Androgen Deprivation for High Risk Localized Prostate Cancer.
The purpose of this study is to evaluate the incidence of urinary and rectal acute side effects of a pelvic and prostatic intensity-modulated arctherapy with simultaneous integrated boost (SIB-IMRT)combined with long-term androgen deprivation for patients with high risk localized prostate cancer
- Conditions
- Prostate Cancer
- Being tested
- Simultaneous integrated boost intensity-modulated arctherapy, Androgen deprivation
- Keywords
- Localized, High risk
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous integrated boost intensity-modulated arctherapyRadiation
Three dose levels will be delivered at each fraction, 5 days a week, 30 fractions :
- Pelvis : 55,5 Gy (1,85 Gy/fr)
- Seminal vesicles : 66 Gy (2,2 Gy/fr)
- Prostate : 72 Gy (2,4 Gy/fr)
Androgen deprivationDrug
Patients will received androgen deprivation for a maximum of three years. This treatment can start six months before radiotherapy and at least the day one of radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy | Experimental | Patient will receive a pelvic and prostatic simultaneous integrated boost intensity-modulated arctherapy (SIB-IMAT) in combination with three years of androgen deprivation Receives: Radiation: Simultaneous integrated boost intensity-modulated arctherapy; Drug: Androgen deprivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Acute urinary and rectal toxicities as a Measure of treatment specific Safety and Tolerability
Acute urinary and rectal toxicities will be assessed according to the NCI CTCAE v4.0 quotation each week during radiotherapy treatment period up to six months after the end of the radiotherapy treatment period.
Measured: From start of radiotherapy to six months after the end of radiotherapy
Secondary outcomes (6)
To evaluate the late urinary and rectal toxicities
Measured: for each patient every 6 months after the end of radiotherapy up to 5 years.
Evaluate the 5-year biochemical-free survival
Measured: for each patient from zero day up to 7 day after the end of radiotherapy, 6 weeks, 3 months, and every 6 months after the end of radiotherapy up to 5 years.
Evaluate the metastase-free survival
Measured: for each patient from zero day up to 7 day after the end of radiotherapy, 6 weeks, 3 months, and every 6 months after the end of radiotherapy up to 5 years.
To evaluate the specific survival
Measured: for each patient from inclusion up to 5 years after the end of radiotherapy.
To evaluate the overall survival
Measured: for each patient from inclusion up to 5 years after the end of radiotherapy.
To evaluate the quality of life
Measured: inclusion day, from zero day up to 7 day after the end of radiotherapy, 6 weeks after the end of the radiotherapy, 3 months after the end of the radiotherapy, every 6 months after the end of radiotherapy up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionMar 2014
Why it stopped: termination of the trial after interim analysis. the main criterion could not be reached
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Etienne MARTIN, MD, Principal investigator, Centre Georges François Leclerc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704027
- Sponsor's protocol ID
- 2012-A00694-39
- Status last verified
- Sep 2014
- First submitted
- 2 Oct 2012
- Last updated
- 18 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Phase II Study Evaluating the Feasibility of a Conformational Pelvic and Prostatic Radiotherapy With Simultaneous Integrated Boost Modulated-intensity Arctherapy (SIB-IMAT) in Combination With Long Term Androgen Deprivation for High Risk Localized Prostate Cancer.
- ClinicalTrials.gov ID
- NCT01704027
- Acronym / sponsor ID
- 2012-A00694-39
- Conditions
- Prostate Cancer
- Keywords
- Localized, High risk
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: termination of the trial after interim analysis. the main criterion could not be reached
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Mar 2014 (actual)
- First posted
- 11 Oct 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 purpose of this study is to evaluate the incidence of urinary and rectal acute side effects of a pelvic and prostatic intensity-modulated arctherapy with simultaneous integrated boost (SIB-IMRT)combined with long-term androgen deprivation for patients with high risk localized prostate cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy | Experimental | Radiation: Simultaneous integrated boost intensity-modulated arctherapy, Drug: Androgen deprivationPatient will receive a pelvic and prostatic simultaneous integrated boost intensity-modulated arctherapy (SIB-IMAT) in combination with three years of androgen deprivation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically confirmed adenocarcinoma of the prostate
- High risk localized adenocarcinoma defined by at least one of the following criteria:
- Patient cN0, pN0 or Nx (negative lymphadenectomy or no lymphadenectomy)
- No pelvic adenopathy ≥ 15 mm on CT or MRI,
- Absence of bone and/or visceral metastasis
Key exclusion criteria (11 listed)
- Prostate cancer histology other than adenocarcinoma,
- pN1 patients (lymph node dissection after histologically proven)
- PSA > 100 ng/ml
- History of cancer within 5 years prior to trial entry (with the exception of basal cell carcinoma skin)
- Patient with severe hypertension uncontrolled by appropriate treatment (≥ 160 mm Hg systolic and / or ≥ 90 mm Hg diastolic)
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 |
|---|---|---|
| Simultaneous integrated boost intensity-modulated arctherapyThree dose levels will be delivered at each fraction, 5 days a week, 30 fractions : * Pelvis : 55,5 Gy (1,85 Gy/fr) * Seminal vesicles : 66 Gy (2,2 Gy/fr) * Prostate : 72 Gy (2,4 Gy/fr) | Radiation | Radiotherapy |
| Androgen deprivationPatients will received androgen deprivation for a maximum of three years. This treatment can start six months before radiotherapy and at least the day one of radiotherapy. | Drug | Radiotherapy |
Primary outcome
Number of Participants with Acute urinary and rectal toxicities as a Measure of treatment specific Safety and Tolerability
Time frame: From start of radiotherapy to six months after the end of radiotherapy
Acute urinary and rectal toxicities will be assessed according to the NCI CTCAE v4.0 quotation each week during radiotherapy treatment period up to six months after the end of the radiotherapy treatment period.
6 secondary outcomes
To evaluate the late urinary and rectal toxicities
Time frame: for each patient every 6 months after the end of radiotherapy up to 5 years.
Evaluate the 5-year biochemical-free survival
Time frame: for each patient from zero day up to 7 day after the end of radiotherapy, 6 weeks, 3 months, and every 6 months after the end of radiotherapy up to 5 years.
Evaluate the metastase-free survival
Time frame: for each patient from zero day up to 7 day after the end of radiotherapy, 6 weeks, 3 months, and every 6 months after the end of radiotherapy up to 5 years.
To evaluate the specific survival
Time frame: for each patient from inclusion up to 5 years after the end of radiotherapy.
To evaluate the overall survival
Time frame: for each patient from inclusion up to 5 years after the end of radiotherapy.
To evaluate the quality of life
Time frame: inclusion day, from zero day up to 7 day after the end of radiotherapy, 6 weeks after the end of the radiotherapy, 3 months after the end of the radiotherapy, every 6 months after the end of radiotherapy up to 5 years.
Results and safety
The study was stopped early (reason given: termination of the trial after interim analysis. the main criterion could not be reached). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2014.
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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.
Etienne MARTIN, MD principal investigator
Centre Georges François Leclerc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Simultaneous integrated boost intensity-modulated arctherapy and Androgen deprivation in people with Prostate Cancer, run by Centre Georges Francois Leclerc at 1 site in France.
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 16 inclusion and 11 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 18 Sep 2014. 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 France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: termination of the trial after interim analysis. the main criterion could not be reached). 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?
Number of Participants with Acute urinary and rectal toxicities as a Measure of treatment specific Safety and Tolerability (time frame: From start of radiotherapy to six months after the end of radiotherapy). 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 18 Sep 2014.