search
Back to results

Low Dose Hemi-body Radiation For Recurrent Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Low Dose Radiotherapy
Sponsored by
Juravinski Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Hamilton Health Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Low Dose Radiation

Arm Description

Subjects will receive low dose body radiation for 5 weeks.

Outcomes

Primary Outcome Measures

PSA response
Proportion of patients with a reduction of PSA levels by at least 50%

Secondary Outcome Measures

Immunological changes
Levels of CD8+ and CD16+ cells, cytokine levels
Adverse Events
NCI-CTCAE
Quality of Life
SF-36

Full Information

First Posted
June 20, 2017
Last Updated
August 8, 2022
Sponsor
Juravinski Cancer Center
Collaborators
McMaster University, Mitacs, Northern Ontario School of Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT03196778
Brief Title
Low Dose Hemi-body Radiation For Recurrent Prostate Cancer
Official Title
Non-Targeted Low Dose Radiotherapy For Recurrent Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 25, 2017 (Actual)
Primary Completion Date
July 18, 2022 (Actual)
Study Completion Date
July 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Juravinski Cancer Center
Collaborators
McMaster University, Mitacs, Northern Ontario School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Dose Radiation
Arm Type
Experimental
Arm Description
Subjects will receive low dose body radiation for 5 weeks.
Intervention Type
Radiation
Intervention Name(s)
Low Dose Radiotherapy
Intervention Description
Patients will receive 10 fractions of very low dose hemi-body radiation, delivered, twice per week, over five weeks
Primary Outcome Measure Information:
Title
PSA response
Description
Proportion of patients with a reduction of PSA levels by at least 50%
Time Frame
Within 12 months of study treatment
Secondary Outcome Measure Information:
Title
Immunological changes
Description
Levels of CD8+ and CD16+ cells, cytokine levels
Time Frame
Within 12 months of study treatment
Title
Adverse Events
Description
NCI-CTCAE
Time Frame
Within 12 months of study treatment
Title
Quality of Life
Description
SF-36
Time Frame
Within 12 months of study treatment

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share IPD. Results to be reported as aggregate outcomes for the group.

Learn more about this trial

Low Dose Hemi-body Radiation For Recurrent Prostate Cancer

We'll reach out to this number within 24 hrs