Prostate MetastasesPhase 2CONSORT-PCNCT05656794
Consolidative Prostate Radiotherapy in Metastatic Prostate Cancer
A Phase 2 study testing Radiotherapy in people with Prostate Metastases, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This is a prospective, randomized phase II trial investigating if radiation treatment delivered every other day for 2 weeks has the same side effects as radiation treatment delivered once weekly for 6 weeks. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Prostate Metastases
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 9 Aug 2023to Aug 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically-proven prostate cancer
- Presence of low-volume or high-volume metastases (high volume defined as the presence of visceral metastases or ≥4 bone lesions with at least 1 lesion beyond the vertebral bodies and pelvis.)
- Planned to or receiving systemic treatment ADT +/- ARAT as per physician discretion (Previous chemotherapy allowed if completed more than 6 weeks prior to randomization.)
- Planned for EBRT
- ECOG 0 or 1
- Age 18 years or older
Who cannot join
- Prior radiotherapy to pelvis
- Active ulcerative colitis or Crohn's Disease, at discretion of treating physician
- Any condition where radiotherapy is contraindicated
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University Health Network, Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Peter Chung, MD, 416-946-4501 ext. 2126, peter.chung@uhn.ca
Peter Chung, MD
About this study
Official title: Consolidative Prostate Radiotherapy in Patients With Metastatic Prostate Cancer
This is a prospective, randomized phase II trial investigating if radiation treatment delivered every other day for 2 weeks has the same side effects as radiation treatment delivered once weekly for 6 weeks.
- Conditions
- Prostate Metastases
- Being tested
- Radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Standard of care radiotherapy administered as per institutional guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Investigational | Experimental | Radiation treatment (36 Gy in 6 fractions) to be delivered every other day over 2 weeks (excluding weekends). Receives: Radiation: Radiotherapy |
| Arm 2 - Standard | Other | Radiation treatment (36 Gy in 6 fractions) to be delivered once a week over 6 weeks. Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of acute toxicity
Compare rates of acute toxicity between participants in Arm 1 and Arm 2. Acute toxicity will be measured using CTCAE V5.0
Measured: 5 years
Secondary outcomes (3)
Rates of late toxicity.
Compare rates of late toxicity between participants in Arm 1 and Arm 2. Late toxicity will be measured using CTCAE V5.0
Measured: 5 years
Measure failure-free survival
Compare failure-free survival, collected through medical records, for participants in Arm 1 and Arm 2
Measured: 5 years
Quality of Life Outcomes
EPIC-26 Questionnaire
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start9 Aug 2023
- Primary completionAug 2031 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate MetastasesStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- TerSera Therapeutics LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656794
- Sponsor's protocol ID
- 22-5921
- Acronym
- CONSORT-PC
- Status last verified
- Mar 2026
- First submitted
- 9 Dec 2022
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consolidative Prostate Radiotherapy in Patients With Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT05656794
- Acronym / sponsor ID
- CONSORT-PC / 22-5921
- Conditions
- Prostate Metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- TerSera Therapeutics LLC
- Study start
- 9 Aug 2023 (actual)
- Primary completion
- Aug 2031 (estimated)
- Study completion
- Aug 2031 (estimated)
- First posted
- 19 Dec 2022 (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.
This is a prospective, randomized phase II trial investigating if radiation treatment delivered every other day for 2 weeks has the same side effects as radiation treatment delivered once weekly for 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Investigational | Experimental | Radiation: RadiotherapyRadiation treatment (36 Gy in 6 fractions) to be delivered every other day over 2 weeks (excluding weekends). |
| Arm 2 - Standard | Other | Radiation: RadiotherapyRadiation treatment (36 Gy in 6 fractions) to be delivered once a week over 6 weeks. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically-proven prostate cancer
- Presence of low-volume or high-volume metastases (high volume defined as the presence of visceral metastases or ≥4 bone lesions with at least 1 lesion beyond the vertebral bodies and pelvis.)
- Planned to or receiving systemic treatment ADT +/- ARAT as per physician discretion (Previous chemotherapy allowed if completed more than 6 weeks prior to randomization.)
- Planned for EBRT
- ECOG 0 or 1
Key exclusion criteria (3 listed)
- Prior radiotherapy to pelvis
- Active ulcerative colitis or Crohn's Disease, at discretion of treating physician
- Any condition where radiotherapy is contraindicated
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 |
|---|---|---|
| RadiotherapyStandard of care radiotherapy administered as per institutional guidelines. | Radiation | Arm 1 - Investigational, Arm 2 - Standard |
Primary outcome
Rates of acute toxicity
Time frame: 5 years
Compare rates of acute toxicity between participants in Arm 1 and Arm 2. Acute toxicity will be measured using CTCAE V5.0
3 secondary outcomes
Rates of late toxicity.
Time frame: 5 years
Measure failure-free survival
Time frame: 5 years
Quality of Life Outcomes
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
Related trials for Prostate Metastases
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
RecruitingObservational study
A Study to Learn About How Safe Darolutamide is and How Well it Works in Combination With Androgen Deprivation Therapy and Docetaxel in Routine Medical Care for Japanese Men With Low Volume Metastatic Hormone-Sensitive Prostate Cancer
Metastatic Hormone-sensitive Prostate Cancer (mHSPC), Low-volume Metastasis
Active, not recruitingPhase 2/3
Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer
Prostate Cancer, Oligometastasis
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Enrolling by invitationPhase 1
A Study of ITC-6146RO in Patients With Advanced or Metastatic Cancer Who Have Failed Standard Therapy
Metastatic Castration-resistant Prostate Cancer, Non-small Cell Lung Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiotherapy in people with Prostate Metastases, run by University Health Network, Toronto 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 6 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 23 Mar 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Chung, MD (416-946-4501 ext. 2126, peter.chung@rmp.uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of acute toxicity (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2026.