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NCT04557501Active, not recruitingPhase 3

PSMA PET/CT Guided Intensification of Therapy in Patients at Risk of Advanced Prostate Cancer

Source: ClinicalTrials.gov · Last updated 13 Mar 2025

Brief summary (registry, in English)

Through the conduct of a Phase III randomized controlled trial, investigators plan to: 1) determine if PSMA PET/CT guided intensification of radiotherapy or surgery improves cancer outcomes compared to conventional imaging-guided therapy in patients at risk of advanced disease, 2) evaluate its impact on toxicity and quality of life, and 3) measure the cost-effectiveness of the PSMA PET/CT guided approach. Participants with high-risk prostate cancer planned for curative-intent standard-of-care radiotherapy or surgery, or with biochemical failure after radical prostatectomy planned for salvage radiotherapy will be enrolled over 3 years (n=776). Those randomized to the investigational arm will have PSMA PET/CT prior to therapy. Based on the imaging results, treating physicians will intensify radiotherapy or surgery unless widely metastatic disease is found, in which case systemic therapy will be intensified.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
800 (actual)
First submitted
14 Sept 2020
Start date
6 Jan 2021
Primary completion date
Jan 2029
Lead sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
NCT number
NCT04557501

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 800
  • From 6 Jan 2021 to the primary completion date, Jan 2029
  • 19 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Active or prior androgen deprivation therapy (except 5-alpha reductase inhibitor) terminated \< 12 months prior to enrollment.
  • Prior or planned PSMA PET/CT scan outside of this clinical trial.
  • Prior curative intent treatment for prostate cancer with local therapy other than surgery (primary radiotherapy or ablative therapies)

Other illness

  • Evidence of extra-pelvic nodal disease (M1a) on conventional imaging (if performed)
  • Evidence of metastatic disease (M1b bone, M1c viscera/soft tissue) on conventional imaging (if performed)

Other

  • Charlson Comorbidity Index \> 5 (see Appendix 2).

Who the study is looking for

  • Histological diagnosis of adenocarcinoma of the prostate planned for curative-intent standard-of-care radiotherapy (primary or salvage post prostatectomy) or radical prostatectomy with lymph node dissection.
  • Age ≥ 18
  • High risk of regional or distant metastases as defined by any of:
  • Newly diagnosed and untreated prostate cancer with CAPRA score 6-10, or stage cN1.
  • Prior history of radical prostatectomy and biochemical failure (PSA\>0.1ng/mL).
  • Patients must provide study-specific informed consent prior to study entry.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (19)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Royal Victoria Regional Health Centre
Coordinator of this site? Confirm its status
BarrieCanadaUnknown status
Tom Baker Cancer Center
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CalgaryCanadaUnknown status
Cross Cancer Institute
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EdmontonCanadaUnknown status
St. Joseph's Healthcare
Coordinator of this site? Confirm its status
HamiltonCanadaUnknown status
Juravinski Cancer Centre
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HamiltonCanadaUnknown status
BC Cancer - Kelowna
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KelownaCanadaUnknown status
Grand River Regional Cancer Centre
Coordinator of this site? Confirm its status
KitchenerCanadaUnknown status
Hopital de la Cite-de-la-Sante
Coordinator of this site? Confirm its status
LavalCanadaUnknown status
London Health Sciences Centre
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LondonCanadaUnknown status
Jewish General Hospital
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MontrealCanadaUnknown status
Charles Lemoyne Hospital
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MontrealCanadaUnknown status
CHUM
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MontrealCanadaUnknown status
McGill University Health Center
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MontrealCanadaUnknown status
CHU de Quebec
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QuébecCanadaUnknown status
CHUS
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SherbrookeCanadaUnknown status
Princess Margaret Cancer Centre
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TorontoCanadaUnknown status
BC Cancer - Vancouver
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VancouverCanadaUnknown status
Windsor Regional Cancer Centre
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WindsorCanadaUnknown status
Cancer Care Manitoba
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WinnipegCanadaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.