Prostate CancerNCT02034955
Prostatectomy Adaptive Radiation Therapy (ART)
A study testing Post-operative Adaptive Radiation Therapy in people with Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This study will ultimately aim to evaluate the side effects of treatment by asking 20 subjects to receive post-operative radiotherapy for prostate cancer with the treatment plan adapted after the first week of treatment to account for changes in the target shape. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Post-operative Adaptive Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2013to 16 May 2023
- 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
- Histologic diagnosis of adenocarcinoma of the prostate after radical prostatectomy AND
- Clinical stage pT3, pT4, or pT2 with positive margin OR
- Any p-Stage with a persistently elevated post-operative PSA > 0.05 ng/ml OR
- A delayed rise in PSA post-operatively
Who cannot join
- Inflammatory bowel disease or other contraindications to radiotherapy
- Prior pelvic radiotherapy
- Previous cytotoxic chemotherapy
- Radiological or pathologic evidence of nodal metastases.
- Planned radiotherapy to pelvic lymph nodes
- Evidence of systemic metastases on imaging.
- Prosthetic hip replacement
- No signed informed consent
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
About this study
Official title: A Feasibility Study of Post-operative Adaptive Radiation Therapy for Localized Prostate Cancer
This study will ultimately aim to evaluate the side effects of treatment by asking 20 subjects to receive post-operative radiotherapy for prostate cancer with the treatment plan adapted after the first week of treatment to account for changes in the target shape. These patients will be asked to complete toxicity scores and a quality of life questionnaire at the start and completion of treatment, and at 3 months 1, 2 and 5 years from the start of radiotherapy. These results will be used to determine the feasibility of the proposed approach, and obtain early estimates of improvements in uncertainty margin requirements for this population of patients.
- Conditions
- Prostate Cancer
- Being tested
- Post-operative Adaptive Radiation Therapy
- Keywords
- Prostate Cancer, Adaptive Radiotherapy, Prostatectomy, Patients who had a prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-operative Adaptive Radiation TherapyRadiation
Also called All Patients enrolled in this study will have additional scans (Cone-Beam CT,MRI) daily during their treatment. This extra imaging will help us see any, changes that might have occurred during radiation treatment and update the treatment plan to include these changes before patient treatment is continued.
| Study group | Role | What they receive |
|---|---|---|
| Post-Operative adaptive radiotherapy | Experimental | All Patients enrolled in this study will have additional scans (Cone-Beam CT, MRI) daily during their treatment. This extra imaging will help us see any changes that might have occurred during radiation treatment and update the treatment plan to include these changes before patient treatment is continued. Receives: Radiation: Post-operative Adaptive Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in radiation dose delivered to target volumes and normal tissue
Measured: 5 years
Secondary outcomes (3)
Time for radiotherapy replanning
Measured: 5 years
Volumetric modulated arc therapy impact in a clinical adaptive Radiotherapy workflow.
Feasibility will be assessed by the time required to perform the adaptive intervention
Measured: 5 years
Toxicity associated with the adaptive radiotherapy technique.
Assessments of gastrointestinal and genitourinary complications using the Common Toxicity Criteria for Adverse Events scoring system and the Expanded Prostate Cancer Index Composite questionnaire.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startJul 2013
- Primary completion16 May 2023
- Study completion16 May 2023
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles N Catton, MD, Principal investigator, The Princess Margaret Cancer Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034955
- Sponsor's protocol ID
- UHN REB 12-5318-C
- Status last verified
- Mar 2024
- First submitted
- 3 Jul 2013
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Post-operative Adaptive Radiation Therapy for Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT02034955
- Acronym / sponsor ID
- UHN REB 12-5318-C
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Adaptive Radiotherapy, Prostatectomy, Patients who had a prostatectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- 16 May 2023 (actual)
- Study completion
- 16 May 2023 (actual)
- First posted
- 14 Jan 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.
This study will ultimately aim to evaluate the side effects of treatment by asking 20 subjects to receive post-operative radiotherapy for prostate cancer with the treatment plan adapted after the first week of treatment to account for changes in the target shape. These patients will be asked to complete toxicity scores and a quality of life questionnaire at the start and completion of treatment, and at 3 months 1, 2 and 5 years from the start of radiotherapy. These results will be used to determine the feasibility of the proposed approach, and obtain early estimates of improvements in uncertainty margin requirements for this population of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-Operative adaptive radiotherapy | Experimental | Radiation: Post-operative Adaptive Radiation TherapyAll Patients enrolled in this study will have additional scans (Cone-Beam CT, MRI) daily during their treatment. This extra imaging will help us see any changes that might have occurred during radiation treatment and update the treatment plan to include these changes before patient treatment is continued. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologic diagnosis of adenocarcinoma of the prostate after radical prostatectomy AND
- Clinical stage pT3, pT4, or pT2 with positive margin OR
- Any p-Stage with a persistently elevated post-operative PSA > 0.05 ng/ml OR
- A delayed rise in PSA post-operatively
Key exclusion criteria (8 listed)
- Inflammatory bowel disease or other contraindications to radiotherapy
- Prior pelvic radiotherapy
- Previous cytotoxic chemotherapy
- Radiological or pathologic evidence of nodal metastases.
- Planned radiotherapy to pelvic lymph nodes
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 |
|---|---|---|
| Post-operative Adaptive Radiation TherapyAlso: All Patients enrolled in this study will have additional scans (Cone-Beam CT,MRI) daily during their treatment. This extra imaging will help us see any, changes that might have occurred during radiation treatment and update the treatment plan to include these changes before patient treatment is continued. | Radiation | Post-Operative adaptive radiotherapy |
Primary outcome
Change in radiation dose delivered to target volumes and normal tissue
Time frame: 5 years
3 secondary outcomes
Time for radiotherapy replanning
Time frame: 5 years
Volumetric modulated arc therapy impact in a clinical adaptive Radiotherapy workflow.
Time frame: 5 years
Toxicity associated with the adaptive radiotherapy technique.
Time frame: 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 18 Mar 2024.
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RecruitingPhase 1
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RecruitingPhase 3
A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer
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RecruitingPhase 2
Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells
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RecruitingPhase 3
Testing Different Dosing Schedules of the Anti-cancer Drug, Lutetium 177Lu PSMA RLT and Its Effect on Patients With Advanced Prostate Cancer, RECIPROCAL Trial
Metastatic Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma
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.
Charles N Catton, MD principal investigator
The Princess Margaret Cancer Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post-operative Adaptive Radiation Therapy in people with Prostate Cancer, 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 4 inclusion and 8 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 18 Mar 2024. 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?
Change in radiation dose delivered to target volumes and normal tissue (time frame: 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 18 Mar 2024.