Low Dose Hemi-body Radiation For Recurrent Prostate Cancer

NCT ID: NCT03196778

Last Updated: 2022-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-25

Study Completion Date

2022-07-18

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low Dose Radiation

Subjects will receive low dose body radiation for 5 weeks.

Group Type EXPERIMENTAL

Low Dose Radiotherapy

Intervention Type RADIATION

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

Interventions

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Low Dose Radiotherapy

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

Intervention Type RADIATION

Eligibility Criteria

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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.
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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McMaster University

OTHER

Sponsor Role collaborator

Mitacs

INDUSTRY

Sponsor Role collaborator

Northern Ontario School of Medicine

OTHER

Sponsor Role collaborator

Juravinski Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Ian Dayes

Assoc. Professor, Dept of Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hamilton Health Sciences

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 39464181 (View on PubMed)

Other Identifiers

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Prostate Hemi-body Irradiation

Identifier Type: -

Identifier Source: org_study_id

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