Image-guided Radiotherapy for Prostate Cancer

(MIDAS-SBRT Trial)

Overseen By Andrew McPartlin, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: University Health Network, Toronto

Disqualifiers: Para-aortic lymph nodes, Distant metastasis, Chronic pelvic inflammatory disease, Previous pelvic radiation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of delivering radiation treatment for prostate cancer that has returned after surgery. Instead of the usual 4 to 6 weeks of treatment, personalized image-guided radiotherapy is delivered in just five sessions over two weeks. This approach aims to target the cancer more accurately and reduce side effects by adjusting the radiation dose based on imaging results. Men who previously underwent prostate cancer surgery and now have cancer return in the prostate area or nearby lymph nodes, as shown by a PSMA PET scan, may be suitable candidates. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this image-guided radiotherapy is safe for prostate cancer patients?

Research has shown that image-guided radiotherapy (IGRT) is generally safe and well-tolerated for prostate cancer patients. Studies indicate that IGRT can better control tumors and reduce side effects related to the stomach and bladder. For instance, patients experienced fewer short-term issues like urinary and bowel problems. One study found that IGRT reduced both immediate and later side effects compared to treatments without image guidance. Overall, evidence suggests that IGRT is a safe option for treating prostate cancer, focusing on minimizing side effects while effectively targeting cancer cells. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about this trial because it explores a new approach to radiotherapy for prostate cancer using molecular imaging. Unlike standard radiotherapy, which applies a uniform dose, this method adjusts the radiation dose based on specific imaging results. It increases the dose to areas with recurrent disease while reducing it in uninvolved regions. This personalized approach could potentially enhance effectiveness and minimize side effects, offering a tailored treatment plan for each patient.

What evidence suggests that image-guided radiotherapy is effective for prostate cancer recurrence?

Research has shown that image-guided radiotherapy (IGRT) effectively treats prostate cancer. Studies indicate that IGRT helps prevent cancer recurrence and reduces side effects related to the digestive and urinary systems. One study found that individuals treated with IGRT experienced fewer long-term urinary problems. These findings suggest that IGRT offers a promising option for managing prostate cancer with fewer side effects. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults (18+) who had prostate cancer surgery over 6 months ago and now have a local or regional recurrence shown by a special scan. They must be in good physical condition, with no distant cancer spread, no prior pelvic radiation, and no chronic pelvic inflammation.

Inclusion Criteria

I had my prostate removed more than 6 months ago.

I am fully active or can do light work despite my illness.

I was first diagnosed with prostate cancer confirmed as adenocarcinoma.

Exclusion Criteria

My cancer has spread to para-aortic lymph nodes or other distant areas.

I have had radiation treatment to my pelvic area.

I have chronic pelvic inflammatory disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Personalized radiotherapy delivered in 5 treatments over two weeks

2 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including routine history, blood collection for PSA and hormone levels, toxicity assessment, and EPIC-26 & IPSS questionnaires

5 years

Visits at 1, 3, 6, 12, 24, 36, and 60 months

What Are the Treatments Tested in This Trial?

Interventions

• Image-guided Radiotherapy

Trial Overview

The study tests personalized image-guided radiotherapy using SBRT. Radiation doses are increased to areas with recurrent cancer and reduced elsewhere, based on PET scans. Treatment is given in 5 sessions over two weeks instead of the usual longer course.

How Is the Trial Designed?

Group I: Molecular Imaging Informed Radiation Dose Escalation and De-escalation Experimental Treatment 1 Intervention

Molecular imaging informed radiation dose escalation to sites of recurrent disease and de-escalation to uninvolved areas.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Citations

1.

redjournal.org

redjournal.org/article/S0360-3016(22)02962-5/fulltext

The Impact of Image Guided Radiation Therapy (IGRT) on ...

This is the first meta-analysis to demonstrate that IGTR control in prostate cancer significantly reduces G2+ acute GI and GU toxicity and improves PSA relapse ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9668680/

The role of image-guided radiotherapy in prostate cancer - PMC

For men receiving prostate radiotherapy, IGRT was associated with an improvement in biochemical tumor control and a reduction in GI and acute GU toxicity, but ...

3.

ascopubs.org

ascopubs.org/doi/10.1200/jco.2012.30.5_suppl.12

Clinical outcomes with high-dose image guided ...

Results: A significant reduction in late urinary toxicity was observed for IGRT patients compared with the non-IGRT patients. The 3-year ...

4.

thegreenjournal.com

thegreenjournal.com/article/S0167-8140(25)05326-5/fulltext

Results of the RCMIGI randomized phase II trial

Intensity-modulated (IMRT) and image-guided (IGRT) radiotherapies reduce radiation-induced toxicities in localized prostate cancer. This randomized phase II ...

5.

mskcc.org

mskcc.org/clinical-updates/image-guided-rt-reduces-potential-under-dosing-high-risk-prostate

Image-Guided RT Reduces Potential Under-Dosing in ...

Results showed that stereotactic radiotherapy was safe and effective ... Image-Guided, Intensity-Modulated Radiotherapy in Prostate Cancer.

6.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2018.36.6_suppl.4

Daily versus weekly prostate cancer image-guided ...

The primary outcome was 5-year recurrence-free survival (RFS). Secondary outcomes included overall survival (OS) and toxicity (CTCAE V.3.0). Post-hoc analyses ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0167814025053265

Image-guided intensity-modulated radiotherapy with ...

Patients with non-metastatic prostate cancer treated with EBRT generally have favorable outcomes, with 5 year-biochemical relapse-free survival ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8506193/

Safety of image-guided radiotherapy in definitive ... - PMC - NIH

We demonstrated that the overall survival for prostate cancer patients with IGRT was not worse than those who did not undergo IGRT.