High Risk Prostate CancerNCT02107287
Hypofractionated Intensity Modulated Radiation Therapy Plus Hormonal Therapy in Patients With High Risk Prostate Cancer
A study testing IMRT Technique in people with High Risk Prostate Cancer, run by Sergio Faria at 1 site in Canada.
Trial summary
Considering the promising results with hypofractionated in low and intermediate risk prostate cancer, our proposal is to translate this experience to patients with high risk prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- High Risk Prostate Cancer
- What is being tested?
- IMRT Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2011to Jun 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pathologically proven diagnosis of adenocarcinoma of the prostate meeting one of the following conditions:
- Clinical Stage >T3 or
- Gleason Score 8 or higher, or
- PSA level >20ng/ml
- Study entry PSA must be obtained within 6 weeks prior to protocol entry
- ECOG <2
Show all 16Show fewer
- Age >18
- History and physical examination within 3 months
- Bone scan and CT scan of the abdomen and pelvis within 3 months with no evidence of bone metastases and no pelvic lymph nodes larger than 1.0cm, unless biopsy negative.
- CBC with differential within 6 weeks prior to protocol entry
- Absolute neutrophil count >2000cells/mm3
- Hemoglobin >8.0 g/dl (the use of transfusion to increase the Hg is acceptable)
- Testosterone level within 6 weeks of protocol entry
- Liver function tests
- Signed informed consent
- Prior use of hormonal therapy for prostate cancer is acceptable if less than 2 months.
Who cannot join
- Prior use of hormonal therapy for prostate cancer for more than 2 months. Previous use of finasteride or dutasteride is allowed.
- Prior invasive malignancy (except non-melanoma skin) unless disease-free for more than 5 years.
- Prior radiotherapy to the pelvis
- Life expectancy of less than 2 years.
Trial locations and contacts
1 site in 1 country.
About this study
Considering the promising results with hypofractionated in low and intermediate risk prostate cancer, our proposal is to translate this experience to patients with high risk prostate cancer. Patients with high risk disease would receive hypofractionated RT to the prostate and to the external and internal iliac lymph nodes using IMRT plus long-term hormonal therapy. The objective of the study is to show that long term grade>2 late toxicity is acceptable and similar to published data using hypofractionated technique in the prostate only.
- Conditions
- High Risk Prostate Cancer
- Being tested
- IMRT Technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMRT TechniqueRadiation
| Study group | Role | What they receive |
|---|---|---|
| IMRT Hypofractionated | Experimental | Neo-adjuvant hormone therapy for three months followed by IMRT combined with a 24-month hormonal therapy. Receives: Radiation: IMRT Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity
Acute and late toxicity following treatment with IMRT to the prostate and pelvic lymphatic chains will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (http://ctep.cancer.gov) for grading of all adverse events will be used in this study.
Measured: First 3 months (acute toxicity)
Secondary outcomes (1)
Freedom from biochemical failure, patterns of failure.
To measure freedom from biochemical failure (PSA measurement) at 5 years.
Measured: At 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startAug 2011
- Primary completionApr 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk 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
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sergio Faria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sergio Faria, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Sergio Faria, M.D., Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02107287
- Sponsor's protocol ID
- 11-519 GEN
- Status last verified
- Sep 2016
- First submitted
- 22 Aug 2012
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypofractionated Intensity Modulated Radiation Therapy Plus Hormonal Therapy in Patients With High Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT02107287
- Acronym / sponsor ID
- 11-519 GEN
- Conditions
- High Risk Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Sergio FariaUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 8 Apr 2014 (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.
Considering the promising results with hypofractionated in low and intermediate risk prostate cancer, our proposal is to translate this experience to patients with high risk prostate cancer. Patients with high risk disease would receive hypofractionated RT to the prostate and to the external and internal iliac lymph nodes using IMRT plus long-term hormonal therapy. The objective of the study is to show that long term grade>2 late toxicity is acceptable and similar to published data using hypofractionated technique in the prostate only.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMRT Hypofractionated | Experimental | Radiation: IMRT TechniqueNeo-adjuvant hormone therapy for three months followed by IMRT combined with a 24-month hormonal therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- pathologically proven diagnosis of adenocarcinoma of the prostate meeting one of the following conditions:
- Clinical Stage >T3 or
- Gleason Score 8 or higher, or
- PSA level >20ng/ml
- Study entry PSA must be obtained within 6 weeks prior to protocol entry
Key exclusion criteria (4 listed)
- Prior use of hormonal therapy for prostate cancer for more than 2 months. Previous use of finasteride or dutasteride is allowed.
- Prior invasive malignancy (except non-melanoma skin) unless disease-free for more than 5 years.
- Prior radiotherapy to the pelvis
- Life expectancy of less than 2 years.
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 |
|---|---|---|
| IMRT Technique | Radiation | IMRT Hypofractionated |
Primary outcome
Toxicity
Time frame: First 3 months (acute toxicity)
Acute and late toxicity following treatment with IMRT to the prostate and pelvic lymphatic chains will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (http://ctep.cancer.gov) for grading of all adverse events will be used in this study.
1 secondary outcome
Freedom from biochemical failure, patterns of failure.
Time frame: At 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
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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.
Sergio Faria, M.D. principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMRT Technique in people with High Risk Prostate Cancer, run by Sergio Faria 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 16 inclusion and 4 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 27 Sep 2016. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Toxicity (time frame: First 3 months (acute toxicity)). 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 27 Sep 2016.