Low Dose Hemi-body Radiation For Recurrent Prostate Cancer

NCT03196778 | Completed DMC

• 1 other identifier: Prostate Hemi-body Irradiation
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• PSA response

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

  Within 12 months of study treatment

Secondary Outcomes (3)

• Immunological changes

  Within 12 months of study treatment

• Adverse Events

  Within 12 months of study treatment

• Quality of Life

  Within 12 months of study treatment

Study Arms (1)

Low Dose Radiation

EXPERIMENTAL

Subjects will receive low dose body radiation for 5 weeks.

Radiation: Low Dose Radiotherapy

Interventions

Low Dose Radiotherapy RADIATION

Patients will receive 10 fractions of very low dose hemi-body radiation, delivered, twice per week, over five weeks

Low Dose Radiation

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Juravinski Cancer Center: lead
• McMaster University: collaborator
• Mitacs: collaborator
• Northern Ontario School of Medicine: collaborator

Study Sites (1)

Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

Related Publications (1)

• Kennedy AE, Dayes IS, Parpia S, Boreham DR, Bowdish DME. Characterizing Hematological Changes Following Repeated Exposure to Non-Targeted Low-Dose Ionizing Radiation in Prostate Cancer Patients. Dose Response. 2024 Oct 2;22(4):15593258241276120. doi: 10.1177/15593258241276120. eCollection 2024 Oct-Dec.

  PMID: 39464181 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Professor, Dept of Oncology

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 23, 2017
• Study Start: September 25, 2017
• Primary Completion: July 18, 2022
• Study Completion: July 18, 2022
• Last Updated: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)