Radiation Therapies for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Must not be taking: Hormonal therapy

Disqualifiers: Other cancer, Obesity, MRI contraindications, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

85 Participants Needed

Trial Summary

What is the purpose of this trial?

Prostate cancer is common in males and may develop over the course of an individual's life. This cancer is often discovered at the time of routine physical examinations and/or blood work or on rectal examination. Once diagnosed, most patients do require some form of treatment so that the prostate cancer does not progress to cause damage and/or shortened lifespan. Occasionally, after patients receive treatment, the investigators have found that an area of cancer remains within the prostate. Those patients with a large area of cancer (i.e. seen on MRI image) appear to have a higher chance of remaining or recurrent prostate cancer even after standard treatment. Thus, the investigators believe that the area of the prostate gland occupied by a dense area of cancer may need more radiation therapy than normal to remain cancer free. Standard therapy currently in place in North America: Currently patients who are diagnosed with prostate cancer have 3 common options: surgery, external beam radiation therapy (EBRT) alone or internal radiation (brachytherapy). Patients may or may not receive hormone therapy alongside the radiation depending on their physician's preference. For those who receive radiation therapy, the tumor typically receives the same dose as the rest of the prostate gland. Findings to date: In the past few years the investigators have discovered that patients with a tumor large enough to be seen on MRI images (\>5mm) have a higher chance than normal of having cancer remain in the prostate, despite receiving treatment for their cancer 3 years earlier. Using new technology investigators can deliver radiation therapy after viewing the prostate tumor on MRI. This guides therapy, allowing the radiation treatment to be targeted to the tumor within the prostate. Based on this earlier success the investigators believe that they can now safely give a higher dose of radiation to specifically target the cancer within the prostate gland. Reason for the study: The investigators would like to test this technology and expertise to give radiation to a higher than normal dose to the tumor nodule in prostate gland.

Research Team

Peter Chung, MD

Principal Investigator

University Health Network, The Princess Margaret

Eligibility Criteria

This trial is for men with prostate cancer who have a life expectancy of over 10 years and are fit (ECOG status 0 or 1). They must have visible tumors on MRI, be at least 18 years old, and not exceed a weight of 136kg due to scanner limits. Men with pacemakers or certain metal implants cannot participate. Those currently on hormone therapy or with other cancers in the last five years are also excluded.

Inclusion Criteria

- Risk of LN involvement <30% (Roach formula = 2/3PSA([G-6]x10))

ECOG performance status 0 or 1 with > 10-year life expectancy

Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed (this does not include standard care laboratory tests or imaging studies).

Exclusion Criteria

Patients weighing >136kgs (weight limit for the scanner tables)

Patients with contraindications to MRI: this includes patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices not compatible with MRI determination. Exceptions will be allowed if deemed sage and appropriate by the MRI technologist.

Current hormonal therapy (Cohort 1) or initiated >2 weeks prior to enrollment (Cohort 2)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Experimental group receives MRI-guided targeted radiation therapy to the prostate tumor

6-8 weeks

Regular imaging and PSA checks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including MRI-guided prostate biopsy at 3 years and regular PSA checks

3 years

Regular follow-up visits per protocol

Treatment Details

Interventions

• High-Dose Rate (HDR) Radiotherapy
• Volumetric Modulated Arc Therapy (VMAT)

Trial Overview The study tests high-dose radiation targeting tumor nodules within the prostate gland using MRI guidance. It aims to see if delivering higher doses directly to the tumor can prevent cancer from remaining or returning after standard treatments like surgery, EBRT, or brachytherapy.

Participant Groups

Group I: Prior Radiation Treatment (Control Cohort) Experimental Treatment 1 Intervention

Patients who received 78Gy RT to the prostate gland 3-4.5 years prior to enrollment. This group will not be receiving any active treatment

Group II: Active Radiation Treatment (Cohort 2) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Princess Margaret Hospital, Canada

Collaborator

Trials

121

Recruited

40,000+