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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a higher dose of radiation directly to a prostate tumor can more effectively prevent prostate cancer recurrence. Researchers use advanced imaging to target radiation treatments precisely at tumor areas within the prostate. Men with prostate cancer who have a noticeable tumor on an MRI and have previously undergone standard treatment might be suitable candidates. This approach seeks to improve outcomes for those at higher risk of recurrent cancer. As an unphased trial, this study provides patients the opportunity to contribute to innovative research that could enhance future treatment strategies.

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

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on hormonal therapy, you may need to stop it if you are in Cohort 1 or if it was started more than two weeks before enrollment in Cohort 2.

What prior data suggests that these radiation therapies are safe for prostate cancer treatment?

Research has shown that both High-Dose Rate (HDR) Radiotherapy and Volumetric Modulated Arc Therapy (VMAT) offer promising and safe treatments for prostate cancer. Studies indicate that HDR radiotherapy is generally safe when used alone for patients with low to intermediate-risk prostate cancer. It is well-tolerated, achieving a five-year recurrence-free survival rate of 75% when combined with other radiation therapies.

Conversely, VMAT has achieved high overall survival rates of about 90% within one to three years, with few severe side effects. This suggests that VMAT is also a safe option, even for patients at high risk.

These findings indicate that both treatments are well-tolerated and provide good safety outcomes for prostate cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for prostate cancer because they offer innovative approaches compared to traditional radiation therapies. High-Dose Rate (HDR) Radiotherapy is unique because it delivers a high dose of radiation in a shorter timeframe, potentially improving precision and reducing damage to surrounding healthy tissues. Volumetric Modulated Arc Therapy (VMAT) stands out because it uses advanced technology to deliver radiation more accurately by adjusting the intensity and shape of the beam in real-time. These features could lead to more effective treatments with fewer side effects, enhancing the overall quality of life for patients.

What evidence suggests that this trial's radiation therapies could be effective for prostate cancer?

Research has shown that High-Dose Rate (HDR) Radiotherapy effectively treats prostate cancer. One study found that patients receiving HDR brachytherapy with external beam radiation therapy (EBRT) had a 5-year survival rate without cancer recurrence of 75%, compared to 61% for those who only received EBRT. This indicates a lower likelihood of cancer returning in patients who received the HDR boost. In this trial, some participants will receive HDR Radiotherapy. Meanwhile, Volumetric Modulated Arc Therapy (VMAT), another treatment option in this trial, has improved outcomes for patients with high-risk prostate cancer. Studies suggest that VMAT targets the tumor more precisely, potentially leading to better cancer control. Both treatments offer promising options for effectively managing prostate cancer. ^{1 2 4 5 6}

Who Is on the Research Team?

Peter Chung, MD

Principal Investigator

University Health Network, The Princess Margaret

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12190164/

Long-Term Outcomes After High-Dose-Rate Brachytherapy ... The 24-year outcomes support the viability and therapeutic efficacy of EBRT combined with a conformal HDR-BT boost for patients with VHR PCa.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6043748/

High dose-rate brachytherapy in the treatment of prostate cancer In summary, HDR brachytherapy boost results in a high disease control rates for men with localized prostate cancer, with strong evidence that it provides ...

3. advancesradonc.org advancesradonc.org/article/S2452-1094(25)00148-4/fulltext

High-Dose-Rate Brachytherapy Boost for Prostate Cancer Results showed a 5-year recurrence-free survival of 75% for the HDR-BT boost group versus 61% for the EBRT alone group.

4. thegreenjournal.com thegreenjournal.com/article/S0167-8140(24)00651-0/fulltext

Prostate high dose-rate brachytherapy as monotherapy for ... We report on the efficacy of a randomized Phase II trial comparing HDR monotherapy delivered as 27 Gy in 2 fractions vs. 19 Gy in 1 fraction with a median ...

5. uclahealth.org uclahealth.org/news/release/study-confirms-safety-and-efficacy-higher-dose-per-day

Study confirms safety and efficacy of higher-dose-per-day ... Patients who received higher dose-escalated MHFRT did not improve cancer control when compared to those receiving standard doses, with five-year ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2405630825000138

Effectiveness, toxicity and impact on quality of life of high ... We found that two-fraction HDR-BT as monotherapy among patients with mainly low- and intermediate-risk prostate cancer appears to be safe in terms of ...