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Trial record 79 of 1439 for:    prostate cancer AND radiation

Low Dose Hemi-body Radiation For Recurrent Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03196778
Recruitment Status : Not yet recruiting
First Posted : June 23, 2017
Last Update Posted : June 26, 2017
Sponsor:
Collaborators:
McMaster University
Mitacs
Northern Ontario School of Medicine
Information provided by (Responsible Party):
Ian Dayes, Juravinski Cancer Center

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Low Dose Radiotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-Targeted Low Dose Radiotherapy For Recurrent Prostate Cancer
Estimated Study Start Date : July 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer


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


Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

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Responsible Party: Ian Dayes, Assoc. Professor, Dept of Oncology, Juravinski Cancer Center
ClinicalTrials.gov Identifier: NCT03196778     History of Changes
Other Study ID Numbers: Prostate Hemi-body Irradiation
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: June 26, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD. Results to be reported as aggregate outcomes for the group.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases