Prostate CancerNCT03196778
Low Dose Hemi-body Radiation For Recurrent Prostate Cancer
A study testing Low Dose Radiotherapy in people with Prostate Cancer, run by Juravinski Cancer Center at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Low Dose Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- 25 Sep 2017to 18 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-Targeted Low Dose Radiotherapy 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.
- Conditions
- Prostate Cancer
- Being tested
- Low Dose Radiotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose RadiotherapyRadiation
Patients will receive 10 fractions of very low dose hemi-body radiation, delivered, twice per week, over five weeks
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Radiation | Experimental | Subjects will receive low dose body radiation for 5 weeks. Receives: Radiation: Low Dose Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA response
Proportion of patients with a reduction of PSA levels by at least 50%
Measured: Within 12 months of study treatment
Secondary outcomes (3)
Immunological changes
Levels of CD8+ and CD16+ cells, cytokine levels
Measured: Within 12 months of study treatment
Adverse Events
NCI-CTCAE
Measured: Within 12 months of study treatment
Quality of Life
SF-36
Measured: Within 12 months of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start25 Sep 2017
- Primary completion18 Jul 2022
- Study completion18 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juravinski Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University, Mitacs, Northern Ontario School of Medicine
- Responsible party
- Principal investigator, Ian Dayes, Juravinski Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196778
- Sponsor's protocol ID
- Prostate Hemi-body Irradiation
- Status last verified
- Aug 2022
- First submitted
- 20 Jun 2017
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD. Results to be reported as aggregate outcomes for the group.
Publications
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.
PubMed 39464181
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Targeted Low Dose Radiotherapy For Recurrent Prostate Cancer
- ClinicalTrials.gov ID
- NCT03196778
- Acronym / sponsor ID
- Prostate Hemi-body Irradiation
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Juravinski Cancer CenterUniversity, hospital or other
- Collaborators
- McMaster University, Mitacs, Northern Ontario School of Medicine
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 18 Jul 2022 (actual)
- Study completion
- 18 Jul 2022 (actual)
- First posted
- 23 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low Dose Radiation | Experimental | Radiation: Low Dose RadiotherapySubjects will receive low dose body radiation for 5 weeks. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Dose RadiotherapyPatients will receive 10 fractions of very low dose hemi-body radiation, delivered, twice per week, over five weeks | Radiation | Low Dose Radiation |
Primary outcome
PSA response
Time frame: Within 12 months of study treatment
Proportion of patients with a reduction of PSA levels by at least 50%
3 secondary outcomes
Immunological changes
Time frame: Within 12 months of study treatment
Adverse Events
Time frame: Within 12 months of study treatment
Quality of Life
Time frame: Within 12 months of study treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Derived from this study: PubMed 39464181Kennedy 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.
- Individual participant dataSharing planned: No. No plan to share IPD. Results to be reported as aggregate outcomes for the group.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Dose Radiotherapy in people with Prostate Cancer, run by Juravinski Cancer Center at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSA response (time frame: Within 12 months of study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03196778, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.