Prostate Cancer (Adenocarcinoma)Phase 2MIDAS-SBRTNCT07515651
Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas in Salvage Radiotherapy Using SBRT for Prostate Cancer to Reduce Treatment Toxicity
A Phase 2 study testing Image-guided Radiotherapy in people with Prostate Cancer (Adenocarcinoma), run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This is a single arm trial that is recruiting a total of 50 participants that have been diagnosed with prostate bed (where the prostate was taken out) or regional (surrounding lymph nodes) recurrence of a prostate cancer following surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma)
- What is being tested?
- Image-guided 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
- 1 Oct 2026to 1 Oct 2034
- 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
- Age ≥ 18 years old.
- Histologically proven initial diagnosis of adenocarcinoma prostate cancer.
- Radical prostatectomy > 6 months prior to commencing SBRT.
- Biochemical relapse with local and/or regional recurrence proven with PSMA PET
- ECOG 0-1.
Who cannot join
- Presence of para-aortic lymph nodes or distant metastasis.
- Chronic pelvic inflammatory disease.
- Contraindication for radiation treatment.
- Previous radiation treatment within the pelvis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
University Health Network - Princess Margaret Cancer Center
Toronto, Ontario, M5G 2M9
Andrew McPartlin, MD, 416-946-4501 ext. 4855, andrew.mcpartlin@uhn.ca
About this study
This is a single arm trial that is recruiting a total of 50 participants that have been diagnosed with prostate bed (where the prostate was taken out) or regional (surrounding lymph nodes) recurrence of a prostate cancer following surgery. Salvage radiation treatment represents the main treatment option, with long-term cure rates on the order of 70%. Currently, salvage radiation treatment to the prostate bed and the pelvic lymph nodes is delivered using external beam radiation therapy (EBRT) in 20-33 sessions, over 4-6.5 weeks. Potential study participants have undergone a PSMA PET scan, which has found recurrent cancer in the prostate bed or lymph nodes. This study will investigate personalizing your radiation treatment based on this information. Participants on this study will receive lower than standard radiation dose to areas of the surgical site which do not show evidence of disease on the scan.
This personalized radiotherapy will be delivered in 5 treatments over two weeks, rather than the four to 6 weeks which is the current standard of care. Participants will have a routine history, blood collection for PSA and hormone levels, toxicity assessment, and EPIC-26 \& IPSS questionnaires at each follow-up visit. These will take place at 1, 3, 6, 12, 24, 36, and 60 months after radiation treatment.
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Being tested
- Image-guided Radiotherapy
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Image-guided RadiotherapyRadiation
- Molecular imaging informed radiation dose escalation to sites of recurrent disease and de-escalation to uninvolved areas with SBRT, 25Gy in 5 fractions to prostate bed +/- pelvic lymph nodes delivered every other day with a boost to PSMA avid disease of 35 Gy in 5 fraction
- Treatment of pelvic lymph nodes and androgen deprivation therapy for 0-24 months at clinician discretion
| Study group | Role | What they receive |
|---|---|---|
| Molecular Imaging Informed Radiation Dose Escalation and De-escalation | Experimental | Molecular imaging informed radiation dose escalation to sites of recurrent disease and de-escalation to uninvolved areas. Receives: Radiation: Image-guided Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation-induced Acute Grade ≥2 Toxicity
Acute (less than or equal to 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
Measured: Baseline to 5-year follow up
Secondary outcomes (4)
Acute and Late GI and GU toxicities
Cumulative incidence function will be used to estimate the cumulative incidence of grade ≥2 GI and GU, graded per Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
Measured: Estimated at 6 months and 2 years following treatment
Local Recurrence
Cumulative incidence function with death as a competing risk will be used to estimate local recurrence
Measured: Estimated at 2 years and 5 years following treatment
Biochemical Disease Free Survival
Defined as survival until evidence of either biochemical progression (defined as a rise in prostate-specific antigen (PSA) ≥0.2ng/ml above the PSA nadir followed by a sequentially equal or higher value) following postoperative radiotherapy, clinical or radiological progression, initiation of non-protocol systemic therapy, or death from prostate cancer
Measured: Estimated at 2 years and 5 years following treatment
Patient-reported quality-of-life assessed by EPIC-26 and IPSS
Patient-Reported Quality of Life will be assessed at baseline and at each follow-up visit (1, 3, 6, 12, 18, 24, 36, 48, and 60 months) using the following assessment questionnaires: EPIC-26 and IPSS
Measured: Baseline to 5-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2034 (estimated)
- Study completion1 Oct 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Adenocarcinoma)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515651
- Sponsor's protocol ID
- 25-6057
- Acronym
- MIDAS-SBRT
- Status last verified
- Sep 2026
- First submitted
- 31 Mar 2026
- Last updated
- 28 Sep 2026
- 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 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas in Salvage Radiotherapy Using SBRT for Prostate Cancer to Reduce Treatment Toxicity
- ClinicalTrials.gov ID
- NCT07515651
- Acronym / sponsor ID
- MIDAS-SBRT / 25-6057
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2034 (estimated)
- Study completion
- 1 Oct 2034 (estimated)
- First posted
- 7 Apr 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.
This is a single arm trial that is recruiting a total of 50 participants that have been diagnosed with prostate bed (where the prostate was taken out) or regional (surrounding lymph nodes) recurrence of a prostate cancer following surgery. Salvage radiation treatment represents the main treatment option, with long-term cure rates on the order of 70%. Currently, salvage radiation treatment to the prostate bed and the pelvic lymph nodes is delivered using external beam radiation therapy (EBRT) in 20-33 sessions, over 4-6.5 weeks. Potential study participants have undergone a PSMA PET scan, which has found recurrent cancer in the prostate bed or lymph nodes. This study will investigate personalizing your radiation treatment based on this information. Participants on this study will receive lower than standard radiation dose to areas of the surgical site which do not show evidence of disease on the scan.
This personalized radiotherapy will be delivered in 5 treatments over two weeks, rather than the four to 6 weeks which is the current standard of care. Participants will have a routine history, blood collection for PSA and hormone levels, toxicity assessment, and EPIC-26 \& IPSS questionnaires at each follow-up visit. These will take place at 1, 3, 6, 12, 24, 36, and 60 months after radiation treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Molecular Imaging Informed Radiation Dose Escalation and De-escalation | Experimental | Radiation: Image-guided RadiotherapyMolecular imaging informed radiation dose escalation to sites of recurrent disease and de-escalation to uninvolved areas. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years old.
- Histologically proven initial diagnosis of adenocarcinoma prostate cancer.
- Radical prostatectomy > 6 months prior to commencing SBRT.
- Biochemical relapse with local and/or regional recurrence proven with PSMA PET
- ECOG 0-1.
Key exclusion criteria (4 listed)
- Presence of para-aortic lymph nodes or distant metastasis.
- Chronic pelvic inflammatory disease.
- Contraindication for radiation treatment.
- Previous radiation treatment within the pelvis.
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 |
|---|---|---|
| Image-guided Radiotherapy* Molecular imaging informed radiation dose escalation to sites of recurrent disease and de-escalation to uninvolved areas with SBRT, 25Gy in 5 fractions to prostate bed +/- pelvic lymph nodes delivered every other day with a boost to PSMA avid disease of 35 Gy in 5 fraction * Treatment of pelvic lymph nodes and androgen deprivation therapy for 0-24 months at clinician discretion | Radiation | Molecular Imaging Informed Radiation Dose Escalation and De-escalation |
Primary outcome
Radiation-induced Acute Grade ≥2 Toxicity
Time frame: Baseline to 5-year follow up
Acute (less than or equal to 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
4 secondary outcomes
Acute and Late GI and GU toxicities
Time frame: Estimated at 6 months and 2 years following treatment
Local Recurrence
Time frame: Estimated at 2 years and 5 years following treatment
Biochemical Disease Free Survival
Time frame: Estimated at 2 years and 5 years following treatment
Patient-reported quality-of-life assessed by EPIC-26 and IPSS
Time frame: Baseline to 5-year follow-up
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 28 Sep 2026.
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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.
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 Image-guided Radiotherapy in people with Prostate Cancer (Adenocarcinoma), 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 5 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: opening soon, as of the sponsor's last update on 28 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 Andrew McPartlin, MD (416-946-4501 ext. 4855, andrew.mcpartlin@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation-induced Acute Grade ≥2 Toxicity (time frame: Baseline to 5-year follow up). 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 28 Sep 2026.