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Active, Not Recruiting

NCT Number: NCT04848909

Stereotactic Body Radiotherapy (SBRT) Post Prostatectomy

This phase I study will assess the toxicity profile and efficacy of SBRT (Stereotactic body radiotherapy) in patients with localized prostate cancer who are considered candidates for post-prostatectomy radiation.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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

Sunnybrook Odette Cancer Centre

Toronto, Onatrio, M4N 3M5, Canada

About this study

Radical prostatectomy is a common treatment for localized prostate cancer, patients with a detectable and/or rising PSA after radical prostatectomy may be offered radiation. An increasing number of patients are being referred post-operatively for radiotherapy, which creates an added burden on radiotherapy departments. Therefore, a strategy that could potentially decrease the number of radiotherapy fractions, yet maintain its efficacy, would be highly desirable for patient convenience, cost saving, and resource utilization as long as the toxicity profile is acceptable. This study will be conducted to asses the toxicity and efficacy of Stereotactic body radiotherapy (SBRT) in post-prostatectomy patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically confirmed diagnosis of adenocarcinoma of the prostate status post radical prostatectomy
  • Completed written informed consent
  • Able and willing to complete EPIC, PORPUS, and EQ-5D questionnaires
  • A detectable PSA ≤ 2.0 ng/ml
  • Two consecutive rises in PSA and final PSA > 0.1 ng/ml OR three or more consecutive rises in PSA

Exclusion criteria

  • Gross residual disease (per conventional imaging, i.e. CT and/or MRI)
  • Histological or radiological node +ve (N1) or distant metastases (M1)
  • Prior pelvic radiotherapy
  • Contraindications to radical pelvic radiotherapy (e.g. connective tissue disease or inflammatory bowel disease)

Treatment and study plan

Stereotactic body radiotherapy (SBRT)

Radiation

Stereotactic body or external-beam radiation therapy (SBRT) is a method of delivery of radiation in precision manner to the prostate bed in this study. The SBRT dose prescription will be 3000 cGy in 5 fractions to the prostate bed and 2500 cGy in 5 fractions to the pelvic nodes if elective nodal irradiation (ENI) is used, delivered every other business day.

Primary outcomes

  1. Early Adverse Events/toxicities experience by Participants

    Time frame: 6.5 years

    Incidence of acute GU and GI toxicities, based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Secondary outcomes

  1. Late Adverse Events/toxicities experienced by Participants

    Time frame: 6.5 years

    Incidence of late GU and GI toxicities (≥6 months) using CTCAE v5.0

  2. Quality of Life of participants using the Expanded Prostate Cancer Index Composite questionnaire

    Time frame: 6.5 years

    Acute and late GU and GI quality of life (QoL) using the Expanded Prostate Cancer Index Composite questionnaire which evaluates participant's function and bother after prostate cancer treatment. Each question is scored from 1-5, 1 being the better outcome and 5 being the worst outcome.

  3. Biochemical disease-free survival

    Time frame: 6.5 years

    Biochemical disease-free survival (bDFS), defined as survival until first evidence of either biochemical progression (PSA of 0.4 ng/mL or greater) following postoperative radiotherapy, PSA of more than 2.0 ng/mL at any time after postoperative radiotherapy, clinical or radiological progression, initiation of non-protocol hormone therapy, or death from prostate cancer

  4. Health Utilities using The Patient-Oriented Prostate Utility Scale

    Time frame: 6.5years

    Health utilities using The Patient-Oriented Prostate Utility Scale to measure health-related quality of life, whether it improves, deteriorates or stay the same. There are 10 questions, each questions has 5 possible answers, with 1 being the better outcome and 5 being the worst outcome.

  5. Health Utilities using EuroQol- 5 Dimension Questionnaire

    Time frame: 6.5years

    Health utilities using the EuroQol- 5 Dimension Questionnaire determines 5 variables, each with 5 possible options, with the first being the best outcome and the last being the worst outcome. The 5 variables include:

    • Mobility
    • Self-care
    • Usual Activities
    • Pain/discomfort
    • Anxiety/depression

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • Credit Valley Hospital
  • Princess Margaret Hospital, Canada
  • Royal Victoria Regional Health Centre

Registry information

Official study title

Post-Prostatectomy Linac-Based Ultrahypofractionated Radiotherapy for Patients With Localized Prostate Cancer: A Treatment Feasibility and Outcomes Multicenter Study

Acronym: PLUTO-MPC

Important dates

Study start
2021
Primary completion
2034
Study completion
2034
First posted
Apr 19, 2021
Registry last updated
May 15, 2025

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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