Prostate Cancer MetastaticPhase 2ANCHORProstateNCT05457699
Radiotherapy to Consolidate Systemic Response in Metastatic Prostate Cancer (ANCHOR-Prostate)
A Phase 2 study testing Metastasis directed radiotherapy (MDRT) and no MDRT in people with Prostate Cancer Metastatic, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
This will be a pragmatic, phase II, registry-based cohort-multiple randomized controlled trial (cmRCT) embedded within an ongoing prospective cancer radiotherapy registry. Eligible patients are those with hormone-sensitive metastatic prostate cancer who have responded to systemic therapy, defined by the absence of PSA… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer Metastatic
- What is being tested?
- Metastasis directed radiotherapy (MDRT) and no MDRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 30 Dec 2022to 30 Jul 2030
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Enrolled in PERa (CHUM CER 17.032) and randomly selected for ANCHOR-Prostate.
- Diagnosis of hormone-sensitive metastatic prostate cancer having responded to systemic therapy.
- PSA non-progressing
- ECOG 0-2
- Metastatic disease suitable for MDRT.
- Primary tumor must have received definitive local treatment (surgery or radiotherapy) with no evidence of local recurrence, or be planned for treatment at the time of MDRT.
Who cannot join
- Planned intermittent systemic therapy.
- Planned radio-ligand therapy.
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
CRCHUM
Montreal, Quebec, H2X 0A9
Mom Phat, 514-890-8254, mom.phat.chum@ssss.gouv.qc.ca
Cynthia Menard, MD
About this study
This will be a pragmatic, phase II, registry-based cohort-multiple randomized controlled trial (cmRCT) embedded within an ongoing prospective cancer radiotherapy registry. Eligible patients are those with hormone-sensitive metastatic prostate cancer who have responded to systemic therapy, defined by the absence of PSA progression, and who are eligible for MDRT. All eligible subjects will be enrolled into the registry and followed longitudinally for oncologic and toxicity outcomes.
From this registry, patients will be randomly selected (1:1) to be offered the experimental arm, which consists of MDRT delivered to metastatic sites identified on imaging in patients who have already initiated systemic therapy (Figure 1). Those not selected will continue to receive standard of care systemic therapy +/- standard of care radiotherapy if clinically indicated. Nor patients or physicians will be blinded.
Read more
Following the initial course of MDRT, prostate-specific antigen (PSA) will be measured, with a minimum assessment at 3 months. This PSA value will be used to determine whether the PSA level has decreased below 0.2 ng/mL. If the PSA remains ≥ 0.2 ng/mL, repeat PSMA-PET will be performed, and a second course of MDRT will be delivered to consolidate residual metastatic lesions.
In this phase II real-world randomized trial, we will determine if AnChoRing (Addition of MDRT for consolidation of response) sites of PSMA PET visible disease when responding to systemic therapy improves the proportion of patients achieving a PSA < 0.2 ng/mL and extends failure-free survival compared to the standard of care.
- Conditions
- Prostate Cancer Metastatic
- Being tested
- Metastasis directed radiotherapy (MDRT), no MDRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metastasis directed radiotherapy (MDRT)Radiation
MDRT to PSMA-PET visible disease at systemic therapy response.
no MDRTOther
Continue systemic therapy per standard of care
| Study group | Role | What they receive |
|---|---|---|
| MDRT consolidation | Experimental | Not described Receives: Radiation: Metastasis directed radiotherapy (MDRT) |
| Control - no MDRT consolidation | Active comparator | Not described Receives: Other: no MDRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA Response
Defined as the proportion of patients achieving a PSA of < 0.2 ng/mL at 12 months post-randomization.
Measured: 12 months
Failure Free Survival (FFS)
FFS is defined as time from randomization to the first of the following events: PSA progression, initiation of next-line systemic therapy, radiographic or clinical progression.
Measured: 3 year
Secondary outcomes (3)
HRQoL
Measured: 5 years
Toxicity
CTCAEv5, incidence rate
Measured: 5 years
Time to progression
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 posted14 Jul 2022
- Study start30 Dec 2022
- Primary completion30 Jul 2030 (estimated)
- Study completion30 Jul 2030 (estimated)
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 Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The 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
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457699
- Sponsor's protocol ID
- 22.115
- Acronym
- ANCHORProstate
- Status last verified
- Apr 2026
- First submitted
- 4 Jul 2022
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Giguere P, Bahig H, Westra S, Roberge D, Bourque JM, Masucci GL, Nkurunziza ES, Freire V, Belliveau C, Duplan D, Vigneault E, Wong P, Lang P, Menard C. Platform for the Evaluation of innovations in Radiation oncology through registry-based conduct of multi-centric pragmatic randomized trials: PERa implementation. Trials. 2026 Apr 24;27(1):437. doi: 10.1186/s13063-026-09709-0.
PubMed 42032732
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiotherapy to Consolidate Systemic Response in Metastatic Prostate Cancer (ANCHOR-Prostate)
- ClinicalTrials.gov ID
- NCT05457699
- Acronym / sponsor ID
- ANCHORProstate / 22.115
- Conditions
- Prostate Cancer Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 30 Dec 2022 (actual)
- Primary completion
- 30 Jul 2030 (estimated)
- Study completion
- 30 Jul 2030 (estimated)
- First posted
- 14 Jul 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 will be a pragmatic, phase II, registry-based cohort-multiple randomized controlled trial (cmRCT) embedded within an ongoing prospective cancer radiotherapy registry. Eligible patients are those with hormone-sensitive metastatic prostate cancer who have responded to systemic therapy, defined by the absence of PSA progression, and who are eligible for MDRT. All eligible subjects will be enrolled into the registry and followed longitudinally for oncologic and toxicity outcomes.
From this registry, patients will be randomly selected (1:1) to be offered the experimental arm, which consists of MDRT delivered to metastatic sites identified on imaging in patients who have already initiated systemic therapy (Figure 1). Those not selected will continue to receive standard of care systemic therapy +/- standard of care radiotherapy if clinically indicated. Nor patients or physicians will be blinded.
Following the initial course of MDRT, prostate-specific antigen (PSA) will be measured, with a minimum assessment at 3 months. This PSA value will be used to determine whether the PSA level has decreased below 0.2 ng/mL. If the PSA remains ≥ 0.2 ng/mL, repeat PSMA-PET will be performed, and a second course of MDRT will be delivered to consolidate residual metastatic lesions.
In this phase II real-world randomized trial, we will determine if AnChoRing (Addition of MDRT for consolidation of response) sites of PSMA PET visible disease when responding to systemic therapy improves the proportion of patients achieving a PSA < 0.2 ng/mL and extends failure-free survival compared to the standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MDRT consolidation | Experimental | Radiation: Metastasis directed radiotherapy (MDRT) |
| Control - no MDRT consolidation | Active comparator | Other: no MDRT |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Enrolled in PERa (CHUM CER 17.032) and randomly selected for ANCHOR-Prostate.
- Diagnosis of hormone-sensitive metastatic prostate cancer having responded to systemic therapy.
- PSA non-progressing
- ECOG 0-2
- Metastatic disease suitable for MDRT.
Key exclusion criteria (2 listed)
- Planned intermittent systemic therapy.
- Planned radio-ligand therapy.
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 |
|---|---|---|
| Metastasis directed radiotherapy (MDRT)MDRT to PSMA-PET visible disease at systemic therapy response. | Radiation | MDRT consolidation |
| no MDRTContinue systemic therapy per standard of care | Other | Control - no MDRT consolidation |
Primary outcome
PSA Response
Time frame: 12 months
Defined as the proportion of patients achieving a PSA of < 0.2 ng/mL at 12 months post-randomization.
Failure Free Survival (FFS)
Time frame: 3 year
FFS is defined as time from randomization to the first of the following events: PSA progression, initiation of next-line systemic therapy, radiographic or clinical progression.
3 secondary outcomes
HRQoL
Time frame: 5 years
Toxicity
Time frame: 5 years
Time to progression
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 8 Sep 2026.
- Derived from this study: PubMed 42032732Giguere P, Bahig H, Westra S, Roberge D, Bourque JM, Masucci GL, Nkurunziza ES, Freire V, Belliveau C, Duplan D, Vigneault E, Wong P, Lang P, Menard C. Platform for the Evaluation of innovations in Radiation oncology through registry-based conduct of multi-centric pragmatic randomized trials: PERa implementation. Trials. 2026 Apr 24;27(1):437. doi: 10.1186/s13063-026-09709-0.
- Individual participant dataSharing planned: Undecided
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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.
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 Metastasis directed radiotherapy (MDRT) and no MDRT in people with Prostate Cancer Metastatic, run by Centre hospitalier de l'Université de Montréal (CHUM) 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 2 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 8 Sep 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 Mom Phat (514-890-8254, mom.phat.chum@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSA Response (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT05457699, 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 8 Sep 2026.