3TMPO (Triple-Tracer Strategy Against Metastatic Prostate Cancer

NCT04000776 | Completed

• 1 other identifier: 3TMPO
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 5

Brief 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

Outcome Measures

Primary Outcomes (3)

• Prevalence of INTRAPATIENT INTERMETASTATIC HETEROGENEITY

  A patient with at least two lesions with discordant FDG/PSMA/OCTREOTATE multi-tracer imaging phenotypes.

  Baseline

• Proportion of neuroendocrine lesion

  Neuroendocrine lesion DEFINITION: A patient with at least one OCTREOTATE-positive lesion or histopathological features of neuroendocrine differentiation

  Baseline

• Proportion of eligible patients for PSMA-RLT or OCTREOTATE-RLT

  Eligibility for PSMA RLT is defined as : Having (1) at least one lesion that is PSMA-positive, and (2) no lesion that is PSMA-negative and FDG-positive. Eligibility for Octreotate RLT: Having (1) at least one lesion that is Octreotate-positive, and (2) no lesion that is Octreotate-negative and FDG-positive.

  Baseline

Secondary Outcomes (6)

• 18F-FDG, 68Ga-PSMA and 68Ga-OCTREOTATE positive lesions

  Baseline

• histologic NED status of lesions

  Baseline

• Pain score

  Baseline and 3-months post-enrolment

• Physical function

  Baseline and 3-months post-enrolment

• Disease-associated symptoms

  Baseline and 3-months post-enrolment

Interventions

FDG Positron emission tomography (PET) scan DIAGNOSTIC_TEST

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.

PSMA Positron emission tomography (PET) scan DIAGNOSTIC_TEST

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

OCTREOTATE Positron emission tomography (PET) scan DIAGNOSTIC_TEST

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).

Optional Bone or soft-tissue biopsies OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

100 patients will be enrolled in five tertiary hospital centers (CIUSSSE-CHUS, CHUQc-UL, CHUM, CIUSSS-COMTL, and MUHC) of the province of Quebec

You may qualify if:

• Male ≥ 18 years old
• Histologically or cytologically proven PCa with or without neuroendocrine differentiation at initial diagnosis
• Castration-resistant prostate cancer with serum testosterone ≤ 50 ng/dL (1.73 nM) anytime while on androgen deprivation therapy
• Evidence of disease progression on prior therapy or watchful waiting. Disease progression is defined by meeting at least one of the following criteria:
• PSA progression defined by a minimum of 2 consecutive rising PSA levels with an interval of ≥1 week between each assessment where the PSA value at screening should be ≥1ng/ml.
• Soft tissue disease ONLY progression\* defined by RECIST 1.1: 1) at least 20% increase in the diameter of target lesions and 2) an absolute increase of ≥ 5 mm of the sum.
• Soft tissue disease ONLY progression\* defined as the appearance of at least one new lesion (soft tissue).
• Bone disease ONLY progression\* defined by two or more new lesions on bone scan.
• Metastatic disease documented by at least 3 active lesions on whole body bone scan and/or measurable soft tissue on CT-scan (lymph nodes and visceral lesions). Metastatic lesions on imaging are defined by RECIST 1.1, either:
• ≥ 10 mm on CT scan or caliper (for lymph nodes, see below)
• ≥ 20 mm on chest X-ray
• lymph node ≥ 15 mm or ≥ 10 mm and having grown by ≥ 5 mm from baseline CT
• any metastasis described on bone scan counts as a lesion
• Able and willing to provide signed informed consent in French or English and to comply with protocol requirements.

You may not qualify if:

• Another non-cutaneous malignancy or melanoma diagnosed in the past 5 years;
• Currently under a randomized-controlled trial with unknown allocation;
• Limited survival prognosis (ECOG ≥3);
• Patients under dialysis;
• Any disease or condition limiting the patient's capacity to execute the study procedures, based on the investigators' opinion.

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Fonds de la Recherche en Santé du Québec: collaborator
• Oncopole: collaborator
• Canadian Cancer Society (CCS): collaborator
• Merck Canada Inc.: collaborator

Study Sites (5)

CHUM, Université de Montréal

Montreal, Quebec, H2X0C1, Canada

Location

McGill University Health Centre

Montreal, Quebec, H4A3J1, Canada

Location

CIUSSS du Centre-Ouest-de -l'île-de-Montreal (CIUSSS-COMTL)

Montreal, Quebec, Canada

Location

CHU de Québec - Université Laval (CRCHUQc-UL),

Québec, Quebec, G1R 3S1, Canada

Location

Centre de recherche du CHUS (CRCHUS), Division of Urology, CIUSSS de l'Estrie - CHUS (CIUSSSE-CHUS)

Sherbrooke, Quebec, J1H5N4, Canada

Location

Related Publications (1)

• Zamanian A, Rousseau E, Buteau FA, Arsenault F, Beaulieu A, April G, Juneau D, Plouznikoff N, Turcotte EE, Allard C, Richard PO, Saad F, Guerin B, Pouliot F, Beauregard JM. The tumour sink effect on 68Ga-PSMA-PET/CT in metastatic castration-resistant prostate cancer and its implications for PSMA-RPT: a sub-analysis of the 3TMPO study. Cancer Imaging. 2025 Jul 15;25(1):91. doi: 10.1186/s40644-025-00910-z.

  PMID: 40665456 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bone or soft-tissues biopsies or blood samples (optional)

MeSH Terms

Interventions

Radionuclide Imaging

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Radioisotope

Study Officials

• Brigitte Guérin, Ph.D

  Department of Nuclear Medicine,Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: June 27, 2019
• Study Start: December 16, 2019
• Primary Completion: March 30, 2023
• Study Completion: June 30, 2023
• Last Updated: August 28, 2023

Record last verified: 2023-08

Locations

CA (5)