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Recruiting

NCT Number: NCT05313815

Moderate Hypofractionated Boost to the Prostate With Pelvic RT in High Risk Prostate Cancer

This is a single-arm phase II prospective trials that is recruiting 100 participants. The study population that is being investigated are patients with localized high-risk or node-positive prostate cancer. Participants will receive external beam radiotherapy as a moderately hypofractionated boost to the prostate with pelvic radiation therapy. Androgen deprivation therapy will be prescribed at the discretion of the treating physician as per standard of care.

Recruiting

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Princess Margaret Cancer Center

Toronto, Ontario, M5G 2M9, Canada

Location status: Recruiting

Location contact

Rachel Glicksman, MD

CONTACT

[email protected]

416-946-4483

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years.
  • Able to provide informed consent.
  • Histologic diagnosis of prostate adenocarcinoma.
  • ECOG performance status 0-1.
  • High-risk localized disease by NCCN criteria (>cT3, Grade group >4, or PSA >20 ng/mL) or clinical N1 disease.
  • Clinical M0 by conventional imaging (computed tomography (CT) and bone scan (BS)) and/or molecular imaging (prostate specific membrane antigen (PSMA)- positron emission tomography (PET))

Exclusion criteria

  • Prior pelvic radiotherapy.
  • Contraindications to radiotherapy

Treatment and study plan

Moderate hypofractionated boost to the prostate with pelvic RT (external beam radiotherapy)

Radiation

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

Primary outcomes

  1. Acute Grade >2 Gastrointestinal Toxicity

    Time frame: Baseline to 5-year follow-up

    Acute (less than or equal to 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Secondary outcomes

  1. Patient-reported quality-of-life assessed by EPIC-26

    Time frame: Baseline to 5-year Follow-up

    Patient-Reported Quality of Life will be assessed at baseline and at each follow-up visit (3-weeks post intervention then every 6 months until 5 years, or more frequently if clinically necessary) using the following assessment questionnaires: 26-Item Expanded Prostate Cancer Index Composite (EPIC-26)

  2. Measure the severity of lower urinary tract symptoms during the study

    Time frame: Baseline to 5-year Follow-up

    Patient-Reported symptoms will be assessed at baseline and at each follow-up visit (3-weeks post intervention then every 6 months until 5 years, or more frequently if clinically necessary) using the following assessment questionnaires: International Prostate Symptom Score (IPSS)

  3. Graded criteria based on CTCAE version 5.0 for acute genitourinary toxicity and late genitourinary and gastrointestinal toxicity

    Time frame: Baseline to 5-year Follow-up

    Acute (less than or equal to 90 days) and long-term (greater than 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

  4. Measure of oncologic outcomes

    Time frame: Baseline to 5-year Follow-up

    Time to development of castrate-resistant prostate cancer (biochemmical or ardiographic progression while having castrate levels of testosterone)

  5. Measure of oncologic outcomes

    Time frame: Baseline to 5-year Follow-up

    Biochemical control rate will be assessed at baseline and at each follow-up visit (3 weeks after treatment then every 6 months until 5 years or more frequently if clinically necessary) by the blood level of prostate-specific antigen (PSA) levels

  6. Measure of onocologic outcomes

    Time frame: Baseline to 5-year Follow-up

    Radiographic control rate will be assess at baseline and weekly during the radiotherapy intervention using cone beam CT or bone scan.

  7. Prostate cancer specific survival based on death from prostate cancer

    Time frame: Baseline to 5-year Follow-up

    Safety will be evaluated by recording prostate cancer mortality at follow-up visits (3-weeks post intervention then every 6 months until 5 years, or more frequently if clinically necessary)

  8. Overall survival

    Time frame: Baseline to 5-year Follow-up

    Safety will be evaluated by recording overall mortality at follow-up visits (3-weeks post intervention then every 6 months until 5 years, or more frequently if clinically necessary).

Study contacts

Contact information is provided by the study sponsor or research team.

Rachel Glicksman, MD

CONTACT

[email protected]

416-946-4486

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Acronym: MOB-RT

Important dates

Study start
2022
Primary completion
2030
Study completion
2030
First posted
Apr 6, 2022
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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