Adenocarcinoma of the ProstatePhase 1/2NCT00915122
Intensity Modulated Radiation Therapy (IMRT) Pelvic Nodes Prostate
A Phase 1/2 study testing Dose Escalated IMRT in people with Adenocarcinoma of the Prostate, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to determine the feasibility and late toxicity of dose escalated radiation therapy to the pelvic lymph nodes and prostate and seminal vesicles in the treatment of high risk prostate cancer. Read more about this study
- Who is it for?
- Ages Up to 80 years, men only
- Conditions the study is for
- Adenocarcinoma of the Prostate
- What is being tested?
- Dose Escalated IMRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2005to 24 Oct 2023
- Phase
- Phase 1/2
- 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 Up to 80 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A histologic diagnosis of adenocarcinoma of the prostate within six months of entry.
- Clinical Stage T1-T2 with (PSA >20 or Gleason score >7)
- Clinical Stage T3, T4
- Bone scan reported as negative for metastases within 6 months of study entry.
- All patients must have a CT scan of the abdomen and pelvis reported as negative for nodal metastases within 12 wks of study entry.
- The patient must not have received greater than 6 months of hormonal therapy.
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- The patient must not have received cytotoxic anticancer therapy prior to study entry.
- Patients must have an ECOG performance status of 2 or less.
- Age 80 years old or less
- Signed informed consent
Who cannot join
- Patients with history of inflammatory bowel disease or other contraindication to radical radiation therapy
- Patients with prior colorectal surgery
- Patients with prior or active malignancy except non-melanoma skin carcinoma within 5 years of the diagnosis of prostate cancer
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network, Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
Official title: A Phase I/II Study of Dose Escalated Intensity Modulated Radiation Therapy (IMRT) for the Treatment of Pelvic Lymph Nodes and Primary Tumour in Patients With Carcinoma of the Prostate
The purpose of this study is to determine the feasibility and late toxicity of dose escalated radiation therapy to the pelvic lymph nodes and prostate and seminal vesicles in the treatment of high risk prostate cancer. All eligible patients with high risk prostate cancer who are going to have primary radiation therapy to the pelvic lymph nodes and prostate seminal vesicles with or without concurrent hormonal therapy will be approached regarding study entry.
Read the detailed description
Prostate cancer is now the most commonly diagnosed cancer in Canadian men and is the third most common cause of cancer death.1 Locally advanced prostate cancer (clinical T3/T4) is uncommon in North America because of earlier diagnosis following widespread PSA testing and patient information campaigns. However, in the past decade the term high-risk prostate cancer has been developed to include the previous locally advanced disease and patient with T1/T2 disease with poor prognostic features (either a high Prostate Specific Antigen or high Gleason score). The risk of involvement of pelvic lymph nodes by prostate cancer for certain subgroups of intermediate risk and most high risk prostate cancer may be substantial. The long term results of conventional dose (66-70 Gy) external beam radiation therapy for intermediate and locally advanced prostate cancer have been disappointing. The combination of hormonal therapy and radiation therapy or radiation therapy dose escalation are the two strategies which have been evaluated and are now used to improve these results.
- Conditions
- Adenocarcinoma of the Prostate
- Being tested
- Dose Escalated IMRT
- Keywords
- IMRT treatment for Prostate cancer patients, Radiation treatment for prostate cancer, cancer of the prostate, Patients with high risk adenocarcinoma of the prostate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose Escalated IMRTRadiation
Patients will receive external beam RT 55.1Gy in 29 once daily fractions to pelvic lymph nodes/prostate/seminal vesicles followed by 24.7Gy in 13 once daily fractions to the prostate/seminal vesicles using intensity modulated radiation therapy.
| Study group | Role | What they receive |
|---|---|---|
| IMRT in prostate cancer | Experimental | Not described Receives: Radiation: Dose Escalated IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the feasibility and late toxicity of dose escalated radiation therapy to the pelvic lymph nodes and prostate and seminal vesicles in the treatment of high risk prostate cancer.
Measured: after all patients have completed study intervention
Secondary outcomes (1)
acute toxicity of therapy;prostate motion when pelvic radiotherapy is delivered;treatment time required to deliver IMRT to the pelvic lymph nodes, prostate and seminal vesicles
Measured: after all patients have completed study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2009 (estimated)
- Study startNov 2005
- Primary completionSep 2010
- Study completion24 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adenocarcinoma of the ProstateStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tara Rosewell, MD, Principal investigator, University Health Network, Princess Margaret Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00915122
- Sponsor's protocol ID
- UHN REB 05-0396-C
- Status last verified
- Dec 2023
- First submitted
- 2 Jun 2009
- Last updated
- 6 Dec 2023
- Results posted
- No
Publications
Bayley A, Rosewall T, Craig T, Bristow R, Chung P, Gospodarowicz M, Menard C, Milosevic M, Warde P, Catton C. Clinical application of high-dose, image-guided intensity-modulated radiotherapy in high-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2010 Jun 1;77(2):477-83. doi: 10.1016/j.ijrobp.2009.05.006. Epub 2009 Sep 3.
PubMed 19733014
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Dose Escalated Intensity Modulated Radiation Therapy (IMRT) for the Treatment of Pelvic Lymph Nodes and Primary Tumour in Patients With Carcinoma of the Prostate
- ClinicalTrials.gov ID
- NCT00915122
- Acronym / sponsor ID
- UHN REB 05-0396-C
- Conditions
- Adenocarcinoma of the Prostate
- Keywords
- IMRT treatment for Prostate cancer patients, Radiation treatment for prostate cancer, cancer of the prostate, Patients with high risk adenocarcinoma of the prostate
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Sep 2010 (actual)
- Study completion
- 24 Oct 2023 (actual)
- First posted
- 5 Jun 2009 (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 determine the feasibility and late toxicity of dose escalated radiation therapy to the pelvic lymph nodes and prostate and seminal vesicles in the treatment of high risk prostate cancer. All eligible patients with high risk prostate cancer who are going to have primary radiation therapy to the pelvic lymph nodes and prostate seminal vesicles with or without concurrent hormonal therapy will be approached regarding study entry.
Detailed description
Prostate cancer is now the most commonly diagnosed cancer in Canadian men and is the third most common cause of cancer death.1 Locally advanced prostate cancer (clinical T3/T4) is uncommon in North America because of earlier diagnosis following widespread PSA testing and patient information campaigns. However, in the past decade the term high-risk prostate cancer has been developed to include the previous locally advanced disease and patient with T1/T2 disease with poor prognostic features (either a high Prostate Specific Antigen or high Gleason score). The risk of involvement of pelvic lymph nodes by prostate cancer for certain subgroups of intermediate risk and most high risk prostate cancer may be substantial. The long term results of conventional dose (66-70 Gy) external beam radiation therapy for intermediate and locally advanced prostate cancer have been disappointing. The combination of hormonal therapy and radiation therapy or radiation therapy dose escalation are the two strategies which have been evaluated and are now used to improve these results.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMRT in prostate cancer | Experimental | Radiation: Dose Escalated IMRT |
Who may qualify
- Ages
- Up to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- A histologic diagnosis of adenocarcinoma of the prostate within six months of entry.
- Clinical Stage T1-T2 with (PSA >20 or Gleason score >7)
- Clinical Stage T3, T4
- Bone scan reported as negative for metastases within 6 months of study entry.
- All patients must have a CT scan of the abdomen and pelvis reported as negative for nodal metastases within 12 wks of study entry.
Key exclusion criteria (3 listed)
- Patients with history of inflammatory bowel disease or other contraindication to radical radiation therapy
- Patients with prior colorectal surgery
- Patients with prior or active malignancy except non-melanoma skin carcinoma within 5 years of the diagnosis of prostate cancer
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 |
|---|---|---|
| Dose Escalated IMRTPatients will receive external beam RT 55.1Gy in 29 once daily fractions to pelvic lymph nodes/prostate/seminal vesicles followed by 24.7Gy in 13 once daily fractions to the prostate/seminal vesicles using intensity modulated radiation therapy. | Radiation | IMRT in prostate cancer |
Primary outcome
Determine the feasibility and late toxicity of dose escalated radiation therapy to the pelvic lymph nodes and prostate and seminal vesicles in the treatment of high risk prostate cancer.
Time frame: after all patients have completed study intervention
1 secondary outcome
acute toxicity of therapy;prostate motion when pelvic radiotherapy is delivered;treatment time required to deliver IMRT to the pelvic lymph nodes, prostate and seminal vesicles
Time frame: after all patients have completed study intervention
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 6 Dec 2023.
- Background: PubMed 19733014Bayley A, Rosewall T, Craig T, Bristow R, Chung P, Gospodarowicz M, Menard C, Milosevic M, Warde P, Catton C. Clinical application of high-dose, image-guided intensity-modulated radiotherapy in high-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2010 Jun 1;77(2):477-83. doi: 10.1016/j.ijrobp.2009.05.006. Epub 2009 Sep 3.
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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.
Tara Rosewell, MD principal investigator
University Health Network, Princess Margaret Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dose Escalated IMRT in people with Adenocarcinoma of the Prostate, run by University Health Network, Toronto 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 10 inclusion and 3 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 6 Dec 2023. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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?
Determine the feasibility and late toxicity of dose escalated radiation therapy to the pelvic lymph nodes and prostate and seminal vesicles in the treatment of high risk prostate cancer. (time frame: after all patients have completed study intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00915122, which also lists 1 linked publication.
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 6 Dec 2023; AzTrials last refreshed its copy on 30 Oct 2026.