Prostate Cancer
Conditions
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.
Interventions
RADIATIONLow Dose Radiotherapy
Patients will receive 10 fractions of very low dose hemi-body radiation, delivered, twice per week, over five weeks
Sponsors
McMaster University
Mitacs
Northern Ontario School of Medicine
Juravinski Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PSA response | Within 12 months of study treatment | Proportion of patients with a reduction of PSA levels by at least 50% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada
Outcome results
None listed