Advanced Imaging for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Must not be taking: Anticoagulants

Disqualifiers: Hip replacement, Bowel disease, others

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

Compensation: Varies

Number of Visits: Unknown

99 Participants Needed

Trial Summary

What is the purpose of this trial?

The integration of magnetic resonance imaging (MRI) in the treatment planning process for prostate cancer will reduce uncertainties in delineation of the prostate gland, and will enable delineation of the urethra, penile bulb, and internal pudendal artery. The integration of daily cone-beam computed tomography (CBCT) will markedly reduce set-up uncertainties, thereby reducing the minimum planning target volume (PTV) margin. By combining MRI simulation and daily CBCT, and by adapting radiation delivery accordingly, the investigators will reduce dose delivered to the rectum, bladder, urethra, and erectile structures. In this study, the investigators seek to determine whether this dose reduction translates to improved patient outcomes. In a prospective, 2-stage design, up to 190 patients will be enrolled. In the first stage, advanced imaging will be integrated without altering dose planning techniques. Stage 2 will reduce dose delivered to normal tissues, and will collect toxicity outcome measures. This clinical trial will be conducted over 3 years.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on anticoagulant therapy (blood thinners), you may need to stop them temporarily for safety reasons.

What data supports the effectiveness of advanced imaging for radiotherapy planning and guidance in prostate cancer treatment?

Advanced imaging techniques, like MRI and CT, are becoming more accurate and are helping doctors better plan and guide prostate cancer treatments. These imaging methods improve the ability to see the cancer's location and size, which can lead to more precise and effective treatment. ^{1 2 3 4 5}

Is advanced imaging for prostate cancer safe for humans?

Advanced imaging used in prostate cancer treatment, like image-guided radiation therapy, generally shows low rates of long-term side effects, especially for the stomach and intestines. However, some patients may experience higher short-term side effects related to the urinary system. ^{6 7 8 9 10}

How is advanced imaging for radiotherapy planning and guidance unique in treating prostate cancer?

Advanced imaging for radiotherapy planning and guidance is unique because it combines different imaging techniques to provide a more precise characterization of prostate cancer, helping to tailor treatment to the individual patient. This approach enhances the accuracy of staging and treatment planning by integrating anatomical, functional, and molecular imaging, which can improve the detection of cancer spread and the assessment of treatment response. ^{1 2 5 11 12}

Research Team

Peter Chung, MD

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

This trial is for men with low or intermediate risk localized prostate cancer, specifically those with a Gleason score of 7 or less, PSA under 20, and no more than half of biopsy cores involved with tumor. It's not for men who've had hip replacements, inflammatory bowel diseases, severe reactions to prostate biopsies, or are on certain anticoagulant therapies.

Inclusion Criteria

My prostate cancer is at an early stage, with a low Gleason score, PSA under 20, and limited tumor involvement.

Exclusion Criteria

I had a severe reaction to a previous prostate biopsy.

I refuse to have fiducial marker placement.

I am not receiving a specific prostate cancer radiation treatment of 78Gy in 39 doses.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment - Stage 1

Advanced imaging integrated without altering dose planning techniques

Approximately 1 year

Daily visits for radiotherapy sessions

Treatment - Stage 2

Dose reduction to normal tissues with collection of toxicity outcome measures

Approximately 1 year

Daily visits for radiotherapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Treatment Details

Interventions

• Advanced imaging for radiotherapy planning and guidance

Trial Overview The study tests if using advanced MRI in planning and daily CBCT imaging during treatment can improve outcomes by reducing radiation doses to non-cancerous parts like the rectum and bladder. The trial has two stages: first integrating advanced imaging without changing dose plans; secondly reducing doses to healthy tissues.

Participant Groups

Group I: MRI + CBCT in prostate cancer 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+

Findings from Research

Magnetic resonance imaging (MRI) significantly improves the staging and characterization of prostate cancer compared to traditional methods like clinical evaluation and CT scans, allowing for better assessment of tumor location and extent.

The combination of MRI with dynamic contrast-enhanced MRI (DCE-MRI) and MR spectroscopic imaging (MRSI) provides critical prognostic information that can guide personalized and minimally invasive treatment strategies for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate cancer imaging. Fuchsjäger, M., Shukla-Dave, A., Akin, O., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Imaging prostate cancer: a multidisciplinary perspective. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

How Advanced Imaging Will Guide Therapeutic Strategies for Patients with Newly Diagnosed Prostate Cancer in the Years to Come. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

A Clinician's Guide to Next Generation Imaging in Patients With Advanced Prostate Cancer (RADAR III). [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

Dosimetric comparison of image guidance by megavoltage computed tomography versus bone alignment for prostate cancer radiotherapy. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Prostate cancer imaging. [2022]

6. Thailand pubmed.ncbi.nlm.nih.gov

Volumetric-Modulated Arc Radiotherapy with Daily Image-Guidance Carries Better Toxicity Profile for Higher Risk Prostate Cancer. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Imaging and evaluation of patients with high-risk prostate cancer. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Acute and late toxicity after three-dimensional conformal image-guided radiotherapy for localized prostate cancer. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

High-dose (80 Gy) intensity-modulated radiation therapy with daily image-guidance as primary treatment for localized prostate cancer. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Reduction of dose delivered to organs at risk in prostate cancer patients via image-guided radiation therapy. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Imaging Diagnosis and Follow-up of Advanced Prostate Cancer: Clinical Perspectives and State of the Art. [2020]

12. England pubmed.ncbi.nlm.nih.gov

Imaging in prostate cancer. [2011]