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Prostate CancerPhase 2/3PSMA-PETgRTNCT03525288

PSMA-PET Guided Radiotherapy

A Phase 2/3 study testing PSMA -PET/CT simulation and Standard-care simulation in people with Prostate Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) at 3 sites in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

PSMA PET/CT has demonstrated higher sensitivity in detecting metastases than current imaging standard of care (CT and bone scan). [18F]DCFPyL is a promising high-sensitivity second generation PSMA-targeted urea-based PET probe. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Prostate Cancer
What is being tested?
PSMA -PET/CT simulation and Standard-care simulation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
3 sitesCanada
Study dates
15 May 2018to 30 May 2027
Phase
Phase 2/3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Enrolled in PERA (CHUM CER 17.0.32) and consented to contact for investigational trials.
  • Histological diagnosis of prostate cancer planned for curative-intent radiotherapy.
  • ECOG 0-1
  • Charlson Cormobidity Index ≤ 4
  • High-risk of distant metastases as defined by any of:
  • Oligometastases (≤5) (regional or distant) identified on conventional staging, with ≤ 3 metastasis in any non-bone organ. For a spine metastasis, direct involvement of adjacent spinal segments would still be considered as "one" tumour. For nodal metastases, more than one involved lymph node in the same ipsilateral nodal region/chain would still count as "one" tumour. Defined nodal regions for this protocol include inguinal, external iliac, internal iliac, common iliac, retroperitoneal, hilar/mediastinal, anterior cervical, posterior cervical, and axillary. Metastases in all other organs that are within 1cm of each other will be considered as "one" tumour.
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  • Subjects with newly diagnosed high-risk (NCCN) localized prostate cancer and CAPRA score 6-10.
  • Subjects with a prior history of treated prostate cancer (RP or RT), and biochemical failure (Phoenix-RT or>0.2ng/ml-RP)
  • Standard staging (bone scan, CT pelvis) within 12 weeks of consent.

Who cannot join

  • Prior androgen deprivation therapy terminated < 12 months prior to enrollment.
  • Prior or planned PET scan.

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • CSSSL - Cité de la Santé Laval

    Laval, Quebec

  • Centre Hospitalier de l'Université de Montréal

    Montreal, Quebec

  • CHU de Québec

    Québec, Quebec

Other trials in Canada

About this study

Official title: PSMA-PET Guided Radiotherapy in Patients With High-Risk, Recurrent, or Oligometastatic Prostate Cancer

PSMA PET/CT has demonstrated higher sensitivity in detecting metastases than current imaging standard of care (CT and bone scan). [18F]DCFPyL is a promising high-sensitivity second generation PSMA-targeted urea-based PET probe. The hypothesis is that definitive radiotherapy (RT) informed by PSMA-PET findings will lead to improved cancer control outcomes compared to RT guided by conventional staging only. This study utilizes cmRCT design in companion to PERA (Partnership initiative for the Evaluation of technological innovation in Radiotherapy).

Conditions
Prostate Cancer
Being tested
PSMA -PET/CT simulation, Standard-care simulation
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PSMA -PET/CT simulationRadiation

    • PET/CT simulation.
    • If no additional lesions detected: RT as planned per standard care.
    • If PSMA-PET/CT imaging consistent with oligometastases (1-5 lesions): all lesions must be treated with definitive RT.
    • If PSMA-PET/CT imaging consistent with widely metastatic disease (>5 lesions): treatment of all detected disease with RT is not recommended, but treatment of the primary site as initially planned is encouraged.

  • Standard-care simulationRadiation

    No PSMA-PET/CT as part of RT treatment planning.

Study groups in NCT03525288
Study groupRoleWhat they receive
PSMA-PETgRTExperimentalPSMA-PET/CT imaging is performed during treatment planning. Treating physicians are informed of test results and advised to include up to 5 PSMA-PET avid sites distant to the prostate gland, if present, in the radiotherapy treatment plan.
Receives: Radiation: PSMA -PET/CT simulation
StandardActive comparatorPatient's receive standard care radiotherapy and do not undergo PSMA-PET/CT imaging.
Receives: Radiation: Standard-care simulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Failure-free survival

    Time to failure event

    Measured: 5 years

Secondary outcomes (5)

  1. Acute and delayed toxicities

    Rate of Attributable Gr2+ toxicities (CTCAE v4.0)

    Measured: 5 years

  2. Rate of failure

    Event rates

    Measured: 5 years

  3. Survival

    Event rates

    Measured: 5 years

  4. Health-related quality of life

    Qol measures

    Measured: 5 years

  5. Detection yield of PSMA PET imaging

    Rate of new lesions identified on imaging

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2018
  2. Study start15 May 2018
  3. Primary completion30 May 2026 (estimated)
  4. Study completion30 May 2027 (estimated)

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients are randomly selected from a standard-care cohort.
Masking
None (open label)
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03525288
Sponsor's protocol ID
17.229
Other IDs
PERA GU17.1
Acronym
PSMA-PETgRT
Status last verified
Mar 2025
First submitted
19 Mar 2018
Last updated
13 Mar 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Belliveau C, Saad F, Duplan D, Petit C, Delouya G, Lambert C, Taussky D, Barkati M, Beauchemin MC, Clavel S, Mok G, Gauthier-Pare AS, Igidbashian L, Jolicoeur M, Nguyen TV, McLaughlin PY, Wong P, Keu KV, DaSilva JN, Juneau D, Menard C. PSMA-PET/CT-guided Intensification of Radiation Therapy for Prostate Cancer (PSMAgRT): 5-yr Analysis of a Phase 2 Randomized Controlled Trial. Eur Urol. 2026 Oct 3:S0302-2838(26)02413-9. doi: 10.1016/j.eururo.2026.09.017. Online ahead of print.

    PubMed 42829266

  • Belliveau C, Saad F, Duplan D, Petit C, Delouya G, Taussky D, Barkati M, Lambert C, Beauchemin MC, Clavel S, Mok G, Igidbashian L, Gauthier-Pare AS, Nguyen TV, McLaughlin PY, Keu KV, DaSilva JN, Juneau D, Menard C. Prostate-Specific Membrane Antigen PET-Guided Intensification of Salvage Radiotherapy After Radical Prostatectomy: A Phase 2 Randomized Clinical Trial. JAMA Oncol. 2025 Dec 1;11(12):1431-1438. doi: 10.1001/jamaoncol.2025.3746.

    PubMed 41037308

  • Petit C, Delouya G, Taussky D, Barkati M, Lambert C, Beauchemin MC, Clavel S, Mok G, Pare AG, Nguyen TV, Duplan D, Keu KV, Saad F, Juneau D, Menard C. PSMA-PET/CT-Guided Intensification of Radiation Therapy for Prostate Cancer (PSMAgRT): Findings of Detection Rate, Effect on Cancer Management, and Early Toxicity From a Phase 2 Randomized Controlled Trial. Int J Radiat Oncol Biol Phys. 2023 Jul 15;116(4):779-787. doi: 10.1016/j.ijrobp.2022.12.055. Epub 2023 Jan 11.

    PubMed 36639035

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing PSMA -PET/CT simulation and Standard-care simulation in people with Prostate Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) at 3 sites 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 9 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: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

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?

Failure-free survival (time frame: 5 years). 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 NCT03525288, which also lists 3 linked publications.

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 13 Mar 2025.

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