Skip to main content
OpenTrials
Completed

NCT Number: NCT03196778

Low Dose Hemi-body Radiation For Recurrent Prostate Cancer

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low dose radiotherapy

Radiation

Patients will receive 10 fractions of very low dose hemi-body radiation, delivered, twice per week, over five weeks

Primary outcomes

  1. PSA response

    Time frame: Within 12 months of study treatment

    Proportion of patients with a reduction of PSA levels by at least 50%

Secondary outcomes

  1. Immunological changes

    Time frame: Within 12 months of study treatment

    Levels of CD8+ and CD16+ cells, cytokine levels

  2. Adverse Events

    Time frame: Within 12 months of study treatment

    NCI-CTCAE

  3. Quality of Life

    Time frame: Within 12 months of study treatment

    SF-36

Sponsors and collaborators

Lead sponsor

Juravinski Cancer Center

Other

Collaborators

  • McMaster University
  • Mitacs
  • Northern Ontario School of Medicine

Registry information

Official study title

Non-Targeted Low Dose Radiotherapy For Recurrent Prostate Cancer

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jun 23, 2017
Registry last updated
Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.