3TMPO (Triple-Tracer Strategy Against Metastatic Prostate Cancer

Summary

Prostate cancer (PCa) is the most common solid organ cancer in North American men. Patients becoming refractory to loco-regional therapy receive androgen deprivation therapy, but their disease will inevitably progress to metastatic castration-resistant prostate cancer (mCRPC). Treatment failure and poor progression-free survival could be explained by the fact that PCa metastases in the same patient may be polyclonal, showing opposite responses to systemic therapies.

This project aims to recruit 100 patients with mCRPC in order to determine the prevalence of intrapatient intermetastasis polyclonality and NED using PET/CT triple-tracer PSMA/FDG/OCTREOTATE imaging and eligibility for either PSMA or OCTREOTATE radioligand therapy (RLT).

Conditions

• Metastatic Castration-resistant Prostate Cancer

Interventions

DIAGNOSTIC_TEST

FDG Positron emission tomography (PET) scan

Patients will undergo 18F-FDG and whole-body PET/CT (vertex to thighs, or to feet if known lower-limb metastases). The patient will be measured and weighed before the exam in order to calculate a personalized dose. An intravenous catheter will be put in place in peripheral vein to allow injection of the tracer.

DIAGNOSTIC_TEST

PSMA Positron emission tomography (PET) scan

Patients will sequentially undergo 68Ga-PSMA and whole-body PET/CT (vertex to thighs, or to feet if known lower-limb metastases).

DIAGNOSTIC_TEST

OCTREOTATE Positron emission tomography (PET) scan

In the case a patient would present at least one PSMA-negative/FDG-positive lesion, he will be referred to undertake a whole-body 68Ga-OCTREOTATE PET/CT within 10 days of the first PET/CT. The delay between this third PET scan and the last one should be minimal (not least than 18 hours, not more than 10 days). Images and data will be reviewed centrally within 4 days by the Imaging Corelab, which will produce a final report confirming patient's eligibility to Radioligand therapy (RLT).

OTHER

Optional Bone or soft-tissue biopsies

Patients presenting FDG-positive/PSMA-negative or Octreotate-positive lesions on imaging will be asked to undergo a biopsy of these lesions (optional) for research purposes. Bone or soft-tissue biopsies will be collected by an interventional radiologist according to site's standard-of-care procedure and sent to the local pathology department for preparation (formalin-fixed and paraffin-embedded); the blocks being sent to the Pathology Corelab.

Sponsors & Collaborators

• Fonds de la Recherche en Santé du Québec

  collaborator OTHER_GOV

• Oncopole

  collaborator UNKNOWN

• Canadian Cancer Society (CCS)

  collaborator OTHER

• Merck Canada Inc.

  collaborator INDUSTRY

• Université de Sherbrooke

  lead OTHER

Principal Investigators

• Brigitte Guérin, Ph.D · Department of Nuclear Medicine,Université de Sherbrooke

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-12-16

Primary Completion

2023-03-30

Completion

2023-06-30

Countries

• Canada

Study Locations