Low Dose Hemi-body Radiation For Recurrent Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Non-Targeted Low Dose Radiotherapy For Recurrent Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03196778
• Other study ID #: Prostate Hemi-body Irradiation
• Status: Completed
• Phase: N/A
• Start date: September 25, 2017
• Est. completion date: July 18, 2022

Study information

• Verified date: August 2022
• Source: Juravinski Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 18, 2022
• Est. primary completion date: July 18, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences	Hamilton	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Juravinski Cancer Center	McMaster University, Mitacs, Northern Ontario School of Medicine

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSA response	Proportion of patients with a reduction of PSA levels by at least 50%	Within 12 months of study treatment
Secondary	Immunological changes	Levels of CD8+ and CD16+ cells, cytokine levels	Within 12 months of study treatment
Secondary	Adverse Events	NCI-CTCAE	Within 12 months of study treatment
Secondary	Quality of Life	SF-36	Within 12 months of study treatment