Prostate CancerPhase 2NCT07578519
Radiation Treatment of the Prostate That is Specially Adjusted for Each Person
A Phase 2 study testing radiotherapy in people with Prostate Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
A number of recent studies have successfully reduced the number of radiotherapy treatments used for prostate cancer from 39 daily treatments to as little as 5 treatments. This study is designed to determine how tumors inside the prostate respond during these 5 treatments on magnetic resonance imaging (MRI) and use… 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?
- radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 26 Aug 2026to Jun 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Histologically confirmed adenocarcinoma of the prostate
- NCCN risk grouping of intermediate or high risk prostate cancer
- Patients must be 18 years of age, or older on the day of signing informed consent and be willing and able to provide written informed consent/assent
- Identifiable lesion within the epithelium of the prostate as determined by the treating radiation oncologist
- Have a prostate imaging reporting and data system (PIRADS) 4 or 5 nodule noted on MRI
- Have not received prior pelvic radiotherapy
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- Life expectancy greater than 10 years
- ECOG performance status <3
- Eligible for SBRT to the prostate
Who cannot join
- No identifiable lesion within the prostate on 3T MRI
- Prior trans-urethral resection of the prostate
- Non-adenocarcinoma histology
- Meeting criteria for very high-risk risk or node positive prostate cancer
- Active inflammatory bowel disease
- Evidence of metastatic disease on CT or bone scan
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- Declined radiotherapy
- Unlikely to be available for all follow-up appointments
- Having received androgen deprivation therapy or 5-alpha reductase therapy prior to trial therapy
- Extensive disease in the posterior prostate or aberrant anatomy that makes the safe delivery of boost irradiation not feasible
- Unable to understand or sign a study consent form after use of interpreter if required
- Has a relative contraindication to radiotherapy including systemic lupus erythematosus, TNM deficiency or scleroderma
- Unable to tolerate or ineligible for mpMR imaging
- Any condition or diagnosis, that could in the opinion of the treating physician or qualified investigator interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Asongna Folefoc contact
Canada1 site, 1 recruiting
- Recruiting
Jack Ady Cancer Centre
Lethbridge, Alberta, T1J 3H5
Charlie Kirkby, 403-388-6872, Charles.Kirkby@cancercarealberta.ca
Kevin Martell, Kevin.Martell@CancerCareAlberta.ca
About this study
Official title: DOSE ADAPTED PERSONALIZED ABLATIVE RADIOTHERAPY OF THE PROSTATE
A number of recent studies have successfully reduced the number of radiotherapy treatments used for prostate cancer from 39 daily treatments to as little as 5 treatments. This study is designed to determine how tumors inside the prostate respond during these 5 treatments on magnetic resonance imaging (MRI) and use that information to design 2 fraction radiotherapy treatments for prostate cancer.
For these two fraction treatments, the first fraction of radiation will use extra radiation to any nodules in the prostate, and the second fraction of radiation will give extra radiation to the nodule(s) in the prostate based on how those nodules responded to the first fraction of radiation. This idea is a relatively old concept but has not been used in the treatment of cancer yet. This research includes a clinical trial that evaluates whether it is safe to design treatments like this.
- Conditions
- Prostate Cancer
- Being tested
- radiotherapy
- Keywords
- Radiotherapy, prostate cancer, treatment, radiation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiotherapyRadiation
External beam radiotherapy via stereotactic body radiotherapy (SBRT).
| Study group | Role | What they receive |
|---|---|---|
| Arm 1/Stage 1: 5 weeks | Experimental | The first group of 25 patients enrolled will receive 5 fractions of radiotherapy to their prostate with or without radiotherapy to their pelvic lymph nodes and an MRI midway through the treatment to assess the response of disease. Receives: Radiation: radiotherapy |
| Arm 2/Stage 2: 3 weeks | Experimental | The second group of 25 patients enrolled in this study will receive a single fraction of radiation to the prostate +/- pelvis with extra radiation to any nodule(s)/tumors in the prostate identified on MR. They will then have a second MR after 3 weeks and based on that MR a second fraction of radiation to the prostate +/- pelvis will be delivered. Receives: Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence
Cumulative incidence of acute common terminology criteria for adverse events (CTCAE) v6.0 ≥ grade 2 genitourinary (GU) toxicity
Measured: Baseline 3 weeks (includes treatment period for Arm 1 and 2) 1 month (includes treatment period for Arm 1) 3 months 6 months 2 years
Secondary outcomes (10)
Incidence
Cumulative incidence of acute CTCAE v6.0 ≥ grade 2 gastrointestinal (GI) toxicity
Measured: Baseline 3 weeks 1 month 3 months 6 months 2 years
Incidence
Cumulative incidence of CTCAE v6.0 ≥ grade 2 GU toxicity at 2 years
Measured: 2 years
Incidence
Cumulative incidence of CTCAE v6.0 ≥ grade 2 GI toxicity at 2 years
Measured: 2 years
international index of erectile function (IIEF-5)
IIEF-5 is a 5-item questionnaire (with a 1- 5 score for each item, 1 being the lowest or worst and 5 the highest/best) used to diagnose erectile disfunction.
Measured: Baseline 3 weeks 1 month 3 months 6 months 2 years
expanded prostate cancer index composite (EPIC)
EPIC is a questionnaire designed to measure Quality of Life issues in patients with Prostate cancer. Overall GU domain is scored from 1 to 5 with 1 being "No problem" and 5 being "Big problem"
Measured: 1 month and 2 years post treatment
EPIC GI
EPIC GI is about bowel habits and abdominal pain and has an overall score of1 - 5 with 1 being "No problem" and 5 being "Big problem"
Measured: 1 month and 2 years post treatment
PSA
Proportion of patients with PSA <0.4ng/mL at 2 years post treatment
Measured: 2 years post treatment
PSA nadir
Absolute PSA nadir at 2 years post treatment (all therapy)
Measured: 2 years post treatment
MRI
MRI based radiographic response of DIL at on treatment week 3
Measured: treatment week 3
MRI response
MRI based radiographic response at 6 months post treatment
Measured: 6 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start26 Aug 2026
- Primary completionJun 2031 (estimated)
- Study completionJun 2032 (estimated)
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
- Non-randomised
- Intervention model
- Sequential
- Model description
- This study is a prospective open label, phase II, two-arm, sequentially allocated non-inferiority cohort trial. This trial design is necessary to determine the multi-parametric magnetic resonance imaging (mpMRI) based treatment response thresholds necessary to inform the DAPAR dose received by patients in the second arm. The first arm and first phase of the study will enroll 25 patients to receive MR imaging-based evaluations of response to 5 fractions of once weekly prostate stereotactic body radiotherapy (SBRT) to a total dose of 4000cGy to the prostate and proximal seminal vesicles and 3625cGy in 5 fractions to a planning target volume (PTV) margin of 3-5mm. The MR response measurements will then be used to deliver 2300cGy in 2 fractions to a PTV margin of 3-5mm around the prostate and proximal seminal vesicles and between 2500cGy and 2900cGy in 2 fractions to the MR based dominant intraprostatic lesion (DIL), delivered 3 weeks apart.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07578519
- Sponsor's protocol ID
- DAPAR
- Status last verified
- Sep 2026
- First submitted
- 1 May 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DOSE ADAPTED PERSONALIZED ABLATIVE RADIOTHERAPY OF THE PROSTATE
- ClinicalTrials.gov ID
- NCT07578519
- Acronym / sponsor ID
- DAPAR
- Conditions
- Prostate Cancer
- Keywords
- Radiotherapy, prostate cancer, treatment, radiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Study start
- 26 Aug 2026 (actual)
- Primary completion
- Jun 2031 (estimated)
- Study completion
- Jun 2032 (estimated)
- First posted
- 11 May 2026 (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.
A number of recent studies have successfully reduced the number of radiotherapy treatments used for prostate cancer from 39 daily treatments to as little as 5 treatments. This study is designed to determine how tumors inside the prostate respond during these 5 treatments on magnetic resonance imaging (MRI) and use that information to design 2 fraction radiotherapy treatments for prostate cancer.
For these two fraction treatments, the first fraction of radiation will use extra radiation to any nodules in the prostate, and the second fraction of radiation will give extra radiation to the nodule(s) in the prostate based on how those nodules responded to the first fraction of radiation. This idea is a relatively old concept but has not been used in the treatment of cancer yet. This research includes a clinical trial that evaluates whether it is safe to design treatments like this.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a prospective open label, phase II, two-arm, sequentially allocated non-inferiority cohort trial. This trial design is necessary to determine the multi-parametric magnetic resonance imaging (mpMRI) based treatment response thresholds necessary to inform the DAPAR dose received by patients in the second arm. The first arm and first phase of the study will enroll 25 patients to receive MR imaging-based evaluations of response to 5 fractions of once weekly prostate stereotactic body radiotherapy (SBRT) to a total dose of 4000cGy to the prostate and proximal seminal vesicles and 3625cGy in 5 fractions to a planning target volume (PTV) margin of 3-5mm. The MR response measurements will then be used to deliver 2300cGy in 2 fractions to a PTV margin of 3-5mm around the prostate and proximal seminal vesicles and between 2500cGy and 2900cGy in 2 fractions to the MR based dominant intraprostatic lesion (DIL), delivered 3 weeks apart.
| Arm | Type | Receives |
|---|---|---|
| Arm 1/Stage 1: 5 weeks | Experimental | Radiation: radiotherapyThe first group of 25 patients enrolled will receive 5 fractions of radiotherapy to their prostate with or without radiotherapy to their pelvic lymph nodes and an MRI midway through the treatment to assess the response of disease. |
| Arm 2/Stage 2: 3 weeks | Experimental | Radiation: radiotherapyThe second group of 25 patients enrolled in this study will receive a single fraction of radiation to the prostate +/- pelvis with extra radiation to any nodule(s)/tumors in the prostate identified on MR. They will then have a second MR after 3 weeks and based on that MR a second fraction of radiation to the prostate +/- pelvis will be delivered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed adenocarcinoma of the prostate
- NCCN risk grouping of intermediate or high risk prostate cancer
- Patients must be 18 years of age, or older on the day of signing informed consent and be willing and able to provide written informed consent/assent
- Identifiable lesion within the epithelium of the prostate as determined by the treating radiation oncologist
- Have a prostate imaging reporting and data system (PIRADS) 4 or 5 nodule noted on MRI
Key exclusion criteria (14 listed)
- No identifiable lesion within the prostate on 3T MRI
- Prior trans-urethral resection of the prostate
- Non-adenocarcinoma histology
- Meeting criteria for very high-risk risk or node positive prostate cancer
- Active inflammatory bowel disease
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 |
|---|---|---|
| radiotherapyExternal beam radiotherapy via stereotactic body radiotherapy (SBRT). | Radiation | Arm 1/Stage 1: 5 weeks, Arm 2/Stage 2: 3 weeks |
Primary outcome
Incidence
Time frame: Baseline 3 weeks (includes treatment period for Arm 1 and 2) 1 month (includes treatment period for Arm 1) 3 months 6 months 2 years
Cumulative incidence of acute common terminology criteria for adverse events (CTCAE) v6.0 ≥ grade 2 genitourinary (GU) toxicity
10 secondary outcomes
Incidence
Time frame: Baseline 3 weeks 1 month 3 months 6 months 2 years
Incidence
Time frame: 2 years
Incidence
Time frame: 2 years
international index of erectile function (IIEF-5)
Time frame: Baseline 3 weeks 1 month 3 months 6 months 2 years
expanded prostate cancer index composite (EPIC)
Time frame: 1 month and 2 years post treatment
EPIC GI
Time frame: 1 month and 2 years post treatment
PSA
Time frame: 2 years post treatment
PSA nadir
Time frame: 2 years post treatment
MRI
Time frame: treatment week 3
MRI response
Time frame: 6 months post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Asongna Folefoc contact
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 radiotherapy in people with Prostate Cancer, run by AHS Cancer Control Alberta 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 9 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 3 Sep 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlie Kirkby (403-388-6872, Charles.Kirkby@cancercarealberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence (time frame: Baseline 3 weeks (includes treatment period for Arm 1 and 2) 1 month (includes treatment period for Arm 1) 3 months 6 months 2 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 3 Sep 2026.