Low Dose Hemi-body Radiation For Recurrent Prostate Cancer

August 8, 2022 updated by: Ian Dayes, Juravinski Cancer Center

Non-Targeted Low Dose Radiotherapy For Recurrent Prostate Cancer

Older studies in animals and humans have shown cancer responses to very low doses of whole-body or hemi-body radiation. To study the effects of low doses of radiation in patients with recurrent prostate cancer, investigators will enroll up to 21 patients for 10 fractions of low dose radiation, delivered over 5 weeks. Participants will be followed on study for 12 months, capturing PSA, CBC, QoL and blood samples for immunological analysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Hamilton Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • A confirmed diagnosis of prostate cancer.
  • Having undergone prior prostate surgery or radiotherapy or both.
  • Evidence of recurrence of the disease as demonstrated by rising PSA levels. Patients are eligible if on androgen blockade or hormone naïve.

Exclusion Criteria:

  • Prior treatment with chemotherapy and/or abiraterone and/or enzalutamide and/or radium-223.
  • Receiving treatment with immunosuppressive medications.
  • Platelet count below 50,000/µl (50 x 109/l) or leukocyte count below 3,000/µl (3 x 109/l) or granulocyte count below 2,000/µl (2 x 109/l).
  • Other medical conditions or co-morbidities which, in the opinion of the Investigator, may interfere with the participant's ability to participate in the study.
  • Language difficulties which may hinder the patient's ability to complete the trial.
  • Inability of the potential participant to provide consent.
  • Lack of independence in daily living activities and any other conditions which, in the opinion of the Investigator, will hinder the participant's ability to participate and complete the study obligations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low Dose Radiation
Subjects will receive low dose body radiation for 5 weeks.
Radiation: Low Dose Radiotherapy
Patients will receive 10 fractions of very low dose hemi-body radiation, delivered, twice per week, over five weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PSA response
Time Frame: Within 12 months of study treatment
Proportion of patients with a reduction of PSA levels by at least 50%
Within 12 months of study treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunological changes
Time Frame: Within 12 months of study treatment
Levels of CD8+ and CD16+ cells, cytokine levels
Within 12 months of study treatment
Adverse Events
Time Frame: Within 12 months of study treatment
NCI-CTCAE
Within 12 months of study treatment
Quality of Life
Time Frame: Within 12 months of study treatment
SF-36
Within 12 months of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Juravinski Cancer Center

Collaborators

Mitacs
McMaster University
Northern Ontario School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2017

Primary Completion (Actual)

July 18, 2022

Study Completion (Actual)

July 18, 2022

Study Registration Dates

First Submitted

June 20, 2017

First Submitted That Met QC Criteria

June 20, 2017

First Posted (Actual)

June 23, 2017

Study Record Updates

Last Update Posted (Actual)

August 10, 2022

Last Update Submitted That Met QC Criteria

August 8, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prostate Hemi-body Irradiation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share IPD. Results to be reported as aggregate outcomes for the group.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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