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Radiation

Radiotherapy for Prostate Cancer (MOB-RT Trial)

N/A
Recruiting
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologic diagnosis of prostate adenocarcinoma.
Age > 18 years.
Must not have
Contraindications to radiotherapy
Prior pelvic radiotherapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 5-year follow-up
Awards & highlights

Summary

This trial is testing a new cancer treatment for 100 patients with high-risk or node-positive prostate cancer. The treatment is a combination of radiotherapy and androgen deprivation therapy.

Who is the study for?
This trial is for men over 18 with high-risk localized prostate cancer or node-positive disease, who are generally in good health (ECOG status 0-1). They must not have had previous pelvic radiotherapy and should be free of metastatic disease as confirmed by imaging. Participants can give informed consent and may receive hormone therapy if their doctor thinks it's necessary.Check my eligibility
What is being tested?
The study is testing a specific type of radiation treatment called moderate hypofractionated boost to the prostate along with pelvic RT. It's designed for patients with serious forms of prostate cancer that hasn't spread beyond the pelvis. The trial will observe how well this intensified radiation approach works.See study design
What are the potential side effects?
Potential side effects from this type of radiation treatment could include urinary issues, bowel problems, fatigue, sexual dysfunction, and skin irritation around the treated area. Hormone therapy might also cause hot flashes, reduced sex drive, weight gain, and bone thinning.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with prostate cancer.
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I am older than 18 years.
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My prostate cancer is considered high-risk based on its stage, grade, or PSA levels.
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I can carry out all my daily activities without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot undergo radiotherapy due to health reasons.
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I have had radiation therapy to my pelvic area before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 5-year follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 5-year follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acute Grade >2 Gastrointestinal Toxicity
Secondary outcome measures
Graded criteria based on CTCAE version 5.0 for acute genitourinary toxicity and late genitourinary and gastrointestinal toxicity
Measure of oncologic outcomes
Measure of onocologic outcomes
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Moderate Hypofracitonated Boost to the Prostate with Pelvic Radiation TherapyExperimental Treatment1 Intervention
External beam radiotherapy- 60 Gy in 20 fractions to the prostate, 48 Gy in 20 fractions to the pelvis, 68 Gy in 20 fraction optional boost to prostatic dominant intraprostatic lesion, 55 Gy in 20 fraction optional boost to involved pelvic lymph nodes

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
External beam radiotherapy (EBRT) works by using high-energy radiation to target and destroy cancer cells in the prostate and surrounding tissues. Moderately hypofractionated EBRT delivers higher doses of radiation per session over a shorter period, which can be more convenient and equally effective. Pelvic radiation therapy extends the treatment area to include pelvic lymph nodes, which may harbor microscopic cancer cells. Androgen deprivation therapy (ADT) reduces levels of male hormones (androgens) that can stimulate the growth of prostate cancer cells. Combining these treatments can enhance the overall effectiveness by attacking cancer cells through different mechanisms, potentially improving outcomes and reducing the risk of recurrence for high-risk prostate cancer patients.
Patient-reported Outcomes After External Beam Radiotherapy With Low Dose Rate Brachytherapy Boost vs Radical Prostatectomy for Localized Prostate Cancer: Five-year Results From a Prospective Comparative Effectiveness Study.Moderate hypofractionation for prostate cancer: A user's guide.HDR Brachytherapy in the Management of High-Risk Prostate Cancer.

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,492 Previous Clinical Trials
489,944 Total Patients Enrolled
64 Trials studying Prostate Cancer
15,400 Patients Enrolled for Prostate Cancer

Media Library

Moderate hypofractionated boost to the prostate with pelvic RT (external beam radiotherapy) (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT05313815 — N/A
Prostate Cancer Research Study Groups: Moderate Hypofracitonated Boost to the Prostate with Pelvic Radiation Therapy
Prostate Cancer Clinical Trial 2023: Moderate hypofractionated boost to the prostate with pelvic RT (external beam radiotherapy) Highlights & Side Effects. Trial Name: NCT05313815 — N/A
Moderate hypofractionated boost to the prostate with pelvic RT (external beam radiotherapy) (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05313815 — N/A
~31 spots leftby Jul 2025
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