Radiotherapy for Prostate Cancer
(DESTINATION 2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of a new radiotherapy approach for men with intermediate-risk localized prostate cancer. Participants will receive either a uniform or de-escalated dose of radiotherapy in two sessions, aiming to minimize side effects and improve outcomes. Men with prostate cancer confirmed through a biopsy and visible on an MRI, who require prostate radical radiotherapy, may be suitable candidates. The study will also assess how well the treatment controls prostate-specific antigen (PSA) levels and gather patient-reported experiences. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future prostate cancer treatments.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that stereotactic body radiotherapy (SBRT) effectively treats localized prostate cancer. However, it may cause more side effects related to the urinary and genital organs, such as issues with the bladder or urethra.
One study on reducing radiation doses for prostate cancer treatment suggested that lowering the doses can be a safe option. This study focused on men with intermediate-risk prostate cancer, similar to those in the current trial.
While some risk of side effects exists, these treatments have demonstrated promise in being both effective and relatively safe. Discussing potential side effects with a healthcare provider remains crucial.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores innovative ways to deliver radiotherapy for prostate cancer. Unlike the standard approach, which typically involves uniform radiation doses to the entire prostate, this trial tests a de-escalated dose strategy. This method uses MRI to identify and target the tumor with higher doses while sparing healthy tissue with lower doses, potentially reducing side effects. By customizing the radiation dose based on tumor location, this approach could improve treatment effectiveness and patient outcomes.
What evidence suggests that this trial's treatments could be effective for prostate cancer?
This trial will compare two radiotherapy approaches for prostate cancer: a uniform dose and a de-escalated dose. Research has shown that radiotherapy effectively treats prostate cancer by targeting and damaging cancer cells while allowing healthy cells to recover. Studies on increasing the radiation dose have shown promising results, with up to 91.4% of high-risk patients experiencing no cancer progression after five years. However, some studies suggest that higher doses don't always improve cancer control. For patients with intermediate risk, the chance of cancer spreading after treatment ranges from 0% to 6%. Overall, radiotherapy remains a well-established treatment for prostate cancer, with evidence supporting its safety and effectiveness.23467
Who Is on the Research Team?
Dr. Danny Vesprini, MSc, MD, FRCPC
Principal Investigator
Sunnybrook Odette Cancer Centre, University of Toronto
Are You a Good Fit for This Trial?
This trial is for men with intermediate-risk localized prostate cancer. Participants should not have advanced or metastatic disease and must be healthy enough to undergo radiotherapy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 2 fraction Stereotactic Body Radiotherapy (SBRT) using an MR Linac with daily adaptation
Follow-up
Participants are monitored for acute GU toxicity and other outcomes post-treatment
Long-term Follow-up
Participants are monitored for late toxicity, PSA control, and patient-reported outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Prostate radical radiotherapy
Trial Overview
The study compares two ways of giving high-dose, MRI-guided radiotherapy in just two sessions: one group gets a uniform dose, while the other gets a lower (de-escalated) dose. Treatment is adapted daily using MRI scans.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Arm 2 (De-escalated dose) will use two dose levels: The benign prostate (on MRI) will receive 20 Gy in 2 fractions with a 0mm PTV margin. The intraprostatic tumour mass(es) as seen on MRI will receive 27 Gy in 2 fractions. A 4mm GTV-PTV margin will be added to the MR visible tumour to form PTV 27Gy.
Arm 1 (Uniform dose) will receive 27 Gy in 2 fractions to the whole prostate + seminal vesicles (SV), the CTV, with 0 mm CTV-PTV margin.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sunnybrook Health Sciences Centre
Lead Sponsor
Elekta Limited
Industry Sponsor
MRL Consortium
Collaborator
Citations
Comparative Effectiveness of Different Radical Radiotherapy ...
In this study, men treated with EBRT combined with HDR-BT had a 36% lower risk of prostate cancer death compared with those treated with CF EBRT to 78 Gy, and ...
De-Escalation of Therapy for Prostate Cancer
Combined high-dose salvage pelvic radiotherapy and ADT (6 months) resulted in 2- and 3-year progression-free survival rates of 81% and 58%, ...
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 ...
Dose‐escalated radiotherapy for clinically localized and ...
Based on our findings, dose‐escalated RT probably results in little to no difference in time to death from prostate cancer, time to death from ...
Dose-escalation in prostate cancer: Results of randomized ...
The data from prospective randomized studies were ultimately disappointing in that they failed to show an overall survival benefit from dose escalation. However ...
Impact of radiation therapy dose escalation on prostate cancer ...
RT BED escalation has resulted in significantly improved PCa FFBF at up to 10 years; but not with improvement in OS, DM, or CSM. Thus, FFBF is a poor surrogate ...
A prospective prostate SBRT dose de-escalation feasibility ...
Stereotactic body radiotherapy (SBRT) is effective for localised prostate cancer but increases genitourinary adverse events (AE).
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