Low Dose Hemi-body Radiation For Recurrent Prostate Cancer

NCT03196778 — Not applicable, Completed, 21 participants, Juravinski Cancer Center

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Non-Targeted Low Dose Radiotherapy For Recurrent Prostate Cancer

Registry	NCT03196778
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	21 (Actual)
Sponsor	Juravinski Cancer Center (Other); collaborators: McMaster University, Mitacs, Northern Ontario School of Medicine
Conditions	Prostate Cancer
Interventions	Low Dose Radiotherapy (Radiation)
Dates	start 2017-09-25, primary completion 2022-07-18, completion 2022-07-18, first posted 2017-06-23, last updated 2022-08-10
Locations	1 site in Canada

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Low Dose Radiation	Experimental	Radiation: Low Dose Radiotherapy	Subjects will receive low dose body radiation for 5 weeks.

Low Dose Radiotherapy (Radiation): Patients will receive 10 fractions of very low dose hemi-body radiation, delivered, twice per week, over five weeks

+Outcome measures

Primary outcomes

PSA response [Within 12 months of study treatment]: Proportion of patients with a reduction of PSA levels by at least 50%

Secondary outcomes

Immunological changes [Within 12 months of study treatment]: Levels of CD8+ and CD16+ cells, cytokine levels
Adverse Events [Within 12 months of study treatment]: NCI-CTCAE
Quality of Life [Within 12 months of study treatment]: SF-36

+Eligibility

Sex: Male

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.

+Locations (1)

Facility	City	Country	Status
Hamilton Health Sciences	Hamilton, Ontario	Canada

+Publications

Results publication: 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