What side effects are associated with this type of intervention?

Common treatments for prostate cancer, such as external beam radiotherapy (EBRT) with a moderately hypofractionated boost to the prostate and pelvic radiation therapy, are associated with several side effects. These include moderate to severe sexual dysfunction in 60-70% of patients, urinary incontinence, and bowel symptoms like urgency and frequency. When combined with brachytherapy, patients may also experience urinary irritative/obstructive symptoms. Androgen deprivation therapy (ADT), often used alongside radiotherapy, can lead to hot flashes, decreased libido, and gynecomastia.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer that are relevant to the context of External Beam Radiotherapy (Moderately Hypofractionated Boost to the Prostate with Pelvic Radiation Therapy). These include androgen deprivation therapy (ADT) agents such as leuprolide, which is often used in combination with radiotherapy. Additionally, androgen receptor signaling inhibitors like enzalutamide and abiraterone have been approved for advanced stages of prostate cancer, including castration-resistant prostate cancer (CRPC). Chemotherapy agents such as docetaxel and cabazitaxel are also FDA-approved for metastatic CRPC. These treatments aim to manage the disease by reducing androgen levels or blocking androgen receptor signaling, thereby inhibiting cancer growth.

What other types of research exist?

Promising novel alternatives to External Beam Radiotherapy for prostate cancer patients include: 1) Brachytherapy (Low-Dose-Rate ¹²⁵I Prostate Brachytherapy), which has shown long-term efficacy and manageable toxicity. 2) High-Dose-Rate Monotherapy, which has demonstrated positive 10-year results. 3) Immunotherapy options like Pembrolizumab for patients with dMMR or high TMB tumors. 4) Androgen Deprivation Therapy (ADT) combined with novel agents like Abiraterone or Darolutamide, especially for high-risk/high-volume disease.

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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

No Placebo-Only Group

Summary

This trial is testing a treatment for high-risk prostate cancer using high-energy X-rays to target and kill cancer cells in the prostate and pelvic area. Some patients may also receive hormone therapy to lower testosterone levels, which can help slow cancer growth. The goal is to see if this combined approach is effective for patients who are at a higher risk of their cancer spreading or not responding to standard treatments.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 5-year follow-up

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acute Grade >2 Gastrointestinal Toxicity

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 6Eligibility criteria met

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

1,531 Previous Clinical Trials

504,323 Total Patients Enrolled

65 Trials studying Prostate Cancer

15,492 Patients Enrolled for Prostate Cancer

Media Library

$Moderate hypofractionated boost to the prostate with pelvic RT (external beam radiotherapy) (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT05313815 — N/A$

$Prostate Cancer Research Study Groups: Moderate Hypofracitonated Boost to the Prostate with Pelvic Radiation Therapy$

$Prostate Cancer Clinical Trial 2023: Moderate hypofractionated boost to the prostate with pelvic RT (external beam radiotherapy) Highlights & Side Effects. Trial Name: NCT05313815 — N/A$

$Moderate hypofractionated boost to the prostate with pelvic RT (external beam radiotherapy) (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05313815 — N/A$