Low Dose Hemi-body Radiation For Recurrent Prostate Cancer

Study Overview
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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.

Official Title
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Non-Targeted Low Dose Radiotherapy For Recurrent Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: Low Dose Radiotherapy


Participation Criteria
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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.
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Dose Radiation<br>Subjects will receive low dose body radiation for 5 weeks. | Radiation: Low Dose Radiotherapy<br>* Patients will receive 10 fractions of very low dose hemi-body radiation, delivered, twice per week, over five weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSA response | Proportion of patients with a reduction of PSA levels by at least 50% | Within 12 months of study treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunological changes | Levels of CD8+ and CD16+ cells, cytokine levels | Within 12 months of study treatment | 
| Adverse Events | NCI-CTCAE | Within 12 months of study treatment | 
| Quality of Life | SF-36 | Within 12 months of study treatment |