Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| McMaster University | OTHER |
| Mitacs | INDUSTRY |
| Northern Ontario School of Medicine | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose Radiation | Experimental | Subjects will receive low dose body radiation for 5 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Dose Radiotherapy | Radiation | Patients will receive 10 fractions of very low dose hemi-body radiation, delivered, twice per week, over five weeks |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Immunological changes | Levels of CD8+ and CD16+ cells, cytokine levels | Within 12 months of study treatment |
| Adverse Events | NCI-CTCAE |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton Health Sciences | Hamilton | Ontario | L8V 5C2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39464181 | Derived | 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. |
Not provided
Not provided
No plan to share IPD. Results to be reported as aggregate outcomes for the group.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Within 12 months of study treatment |
| Quality of Life | SF-36 | Within 12 months of study treatment |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |