Prostate CancerARTGUNCT03909893
A Study of Adaptive Radiation Therapy for Pelvic Genitourinary Cancer
A study testing Adaptive Radiation Therapy in people with Prostate Cancer and Bladder Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Radical radiation therapy for prostate cancer is a common treatment that has shown to improve clinical outcomes in a post-operative setting. However, radiation therapy after surgery poses a greater risk for bladder and rectum injury for patients with prostate or bladder cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Bladder Cancer
- What is being tested?
- Adaptive Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2023to Jan 2025
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic diagnosis of adenocarcinoma of the prostate after radical prostatectomy:
- Clinical stage pT3, pT4, or pT2 with positive margin; OR,
- any p-stage with persistently elevated post-operative PSA > 0.05ng/mL; OR,
- a delayed rise in PSA post-operative
- Histologic diagnosis of transitional cell carcinoma of the bladder with intact bladder and:
- Clinical stage cT2, cT3, cT4, and N0 or N1
Who cannot join
- Inflammatory bowel disease or other contraindications to radiotherapy.
- Prior pelvic radiotherapy
- Previous cytotoxic chemotherapy
- Evidence of systemic metastases on imaging
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network, Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
Radical radiation therapy for prostate cancer is a common treatment that has shown to improve clinical outcomes in a post-operative setting. However, radiation therapy after surgery poses a greater risk for bladder and rectum injury for patients with prostate or bladder cancer. For prostate cancer patients, the risk is further amplified when pelvic nodes are part of the target irradiated volume. For bladder cancer patients, the risk of injury increases when more of the bladder is part of the target volume. Using an adaptive radiation therapy approach allows for correcting any shifts in the target volume. ART approach uses images from treatment to adapt the treatment plan. This study will use Adaptive Radiation Therapy for patients who receive pelvic nodal radiotherapy for either prostate or bladder cancer. Their treatment plans will adapted using MRI scans and CBCT scans taken during their first week of radiotherapy to account for any shifts in the target volume. The purpose of this study is to evaluate the feasibility of ART approach and its and on treatment plan quality metrics for pelvic radiotherapy. Acute and late toxicities will also be evaluated. 40 participants (minimum of 10 bladder cancer patients) will be enrolled. The participants will be followed for a period of 5 years post radiation therapy, during which they will have PSA as per standard practice, along with follow-up questionnaires (EPIC for prostate cancer patients and BUSS for bladder cancer patients).
- Conditions
- Prostate Cancer, Bladder Cancer
- Being tested
- Adaptive Radiation Therapy
- Keywords
- Adaptive, Radiation Therapy
- Medical subject headings
- Prostatic Neoplasms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive Radiation TherapyRadiation
Cone-beam CT images as well as MRI scans will be used to make any changes to the radiation treatment plan, part of the way through the treatment. Adaptation of treatment plans may allow smaller target volumes to be treated with higher doses, while minimizing the side effects to surrounding organs.
| Study group | Role | What they receive |
|---|---|---|
| Adaptive Radiation Therapy | Experimental | Not described Receives: Radiation: Adaptive Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosimetry
Difference in dose-volume irradiation of critical organs between original and adapted plan will be compared.
Measured: 5 years
Secondary outcomes (6)
Toxicity in Patients
To determine a preliminary measure of toxicity with this technique. CTCAE toxicity data will be described for this population.
Measured: Before Radiation Therapy, and at Month 3, Year 1, 3 & 5 after Radiation Therapy
Bladder Cancer Patients' Quality of Life Function
Bladder Utility Symptom Scale (BUSS) questionnaires will be scored and analyzed to determine QoL function. BUSS will be scored (1-100) as per standard criteria. Data will be analyzed as a continuous variable
Measured: Before Radiation Therapy, and at Month 3, Year 1, 3 & 5 after Radiation Therapy
Prostate Cancer Patients' Quality of Life Function
Expanded Prostate Cancer Index Composite (EPIC) questionnaires will be scored and analyzed to determine QoL function. EPIC will be scored (1-100) as per standard criteria. Data will be analyzed as a continuous variable
Measured: Before Radiation Therapy, and at Month 3, Year 1, 3 & 5 after Radiation Therapy
Biochemical Control in Prostate Patients
For prostate patients, patients will be considered to have biochemical failure if the PSA has risen 2ng above nadir.
Measured: PSA will be done before Radiation Therapy, and at Month 3, Year 1, 3 and 5 after Radiation Therapy
Local Control in Bladder Patients
Local control will be defined by an absence of clinically locally recurrent disease
Measured: 5 years
Feasibility of the use of Fiducial markers for bladder RT: quality of target delineation using fiducial markers
Feasibility will be determined by analyzing the quality of target delineation using fiducial markers in bladder cancer patients.
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 posted10 Apr 2019
- Study startOct 2023 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Why it stopped: This study is being closed. The protocol may be reviewed and consolidated under a new study currently in development.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Chung, MD, Principal investigator, Princess Margaret Cancer Centre - University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909893
- Sponsor's protocol ID
- 17-5929
- Acronym
- ARTGU
- Status last verified
- Mar 2024
- First submitted
- 14 May 2018
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Adaptive Radiation Therapy for Pelvic Genitourinary Cancer
- ClinicalTrials.gov ID
- NCT03909893
- Acronym / sponsor ID
- ARTGU / 17-5929
- Conditions
- Prostate Cancer, Bladder Cancer
- Keywords
- Adaptive, Radiation Therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study is being closed. The protocol may be reviewed and consolidated under a new study currently in development.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 10 Apr 2019 (actual)
- 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.
Radical radiation therapy for prostate cancer is a common treatment that has shown to improve clinical outcomes in a post-operative setting. However, radiation therapy after surgery poses a greater risk for bladder and rectum injury for patients with prostate or bladder cancer. For prostate cancer patients, the risk is further amplified when pelvic nodes are part of the target irradiated volume. For bladder cancer patients, the risk of injury increases when more of the bladder is part of the target volume. Using an adaptive radiation therapy approach allows for correcting any shifts in the target volume. ART approach uses images from treatment to adapt the treatment plan. This study will use Adaptive Radiation Therapy for patients who receive pelvic nodal radiotherapy for either prostate or bladder cancer. Their treatment plans will adapted using MRI scans and CBCT scans taken during their first week of radiotherapy to account for any shifts in the target volume. The purpose of this study is to evaluate the feasibility of ART approach and its and on treatment plan quality metrics for pelvic radiotherapy. Acute and late toxicities will also be evaluated. 40 participants (minimum of 10 bladder cancer patients) will be enrolled. The participants will be followed for a period of 5 years post radiation therapy, during which they will have PSA as per standard practice, along with follow-up questionnaires (EPIC for prostate cancer patients and BUSS for bladder cancer patients).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adaptive Radiation Therapy | Experimental | Radiation: Adaptive Radiation Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologic diagnosis of adenocarcinoma of the prostate after radical prostatectomy:
- Histologic diagnosis of transitional cell carcinoma of the bladder with intact bladder and:
Key exclusion criteria (4 listed)
- Inflammatory bowel disease or other contraindications to radiotherapy.
- Prior pelvic radiotherapy
- Previous cytotoxic chemotherapy
- Evidence of systemic metastases on imaging
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 |
|---|---|---|
| Adaptive Radiation TherapyCone-beam CT images as well as MRI scans will be used to make any changes to the radiation treatment plan, part of the way through the treatment. Adaptation of treatment plans may allow smaller target volumes to be treated with higher doses, while minimizing the side effects to surrounding organs. | Radiation | Adaptive Radiation Therapy |
Primary outcome
Dosimetry
Time frame: 5 years
Difference in dose-volume irradiation of critical organs between original and adapted plan will be compared.
6 secondary outcomes
Toxicity in Patients
Time frame: Before Radiation Therapy, and at Month 3, Year 1, 3 & 5 after Radiation Therapy
Bladder Cancer Patients' Quality of Life Function
Time frame: Before Radiation Therapy, and at Month 3, Year 1, 3 & 5 after Radiation Therapy
Prostate Cancer Patients' Quality of Life Function
Time frame: Before Radiation Therapy, and at Month 3, Year 1, 3 & 5 after Radiation Therapy
Biochemical Control in Prostate Patients
Time frame: PSA will be done before Radiation Therapy, and at Month 3, Year 1, 3 and 5 after Radiation Therapy
Local Control in Bladder Patients
Time frame: 5 years
Feasibility of the use of Fiducial markers for bladder RT: quality of target delineation using fiducial markers
Time frame: 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
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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.
Peter Chung, MD principal investigator
Princess Margaret Cancer Centre - University Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive Radiation Therapy in people with Prostate Cancer and Bladder 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 6 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: withdrawn, as of the sponsor's last update on 19 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 was withdrawn before enrolling participants, so there are no results.
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?
Dosimetry (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 19 Mar 2024.