Clinical trial · Observational
3TMPO (Triple-Tracer Strategy Against Metastatic Prostate Cancer
Triple-tracer Molecular Imaging Using 18F-FDG, 68Ga-PSMA and 68Ga-OCTREOTATE to Characterize Metastatic Castration-resistant Prostate Cancer (mCRPC) and Evaluate Eligibility for Radionuclide Therapies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FDG Positron emission tomography (PET) scan | Diagnostic Test | — | UNRESOLVED |
| OCTREOTATE Positron emission tomography (PET) scan | Diagnostic Test | — | UNRESOLVED |
| Optional Bone or soft-tissue biopsies | Other | — | UNRESOLVED |
| PSMA Positron emission tomography (PET) scan | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Prevalence of INTRAPATIENT INTERMETASTATIC HETEROGENEITY
- timeFrame
- Baseline
- description
- A patient with at least two lesions with discordant FDG/PSMA/OCTREOTATE multi-tracer imaging phenotypes.
- measure
- Proportion of neuroendocrine lesion
- timeFrame
- Baseline
- description
- Neuroendocrine lesion DEFINITION: A patient with at least one OCTREOTATE-positive lesion or histopathological features of neuroendocrine differentiation
- measure
- Proportion of eligible patients for PSMA-RLT or OCTREOTATE-RLT
- timeFrame
- Baseline
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male ≥ 18 years old 2. Histologically or cytologically proven PCa with or without neuroendocrine differentiation at initial diagnosis 3. Castration-resistant prostate cancer with serum testosterone ≤ 50 ng/dL (1.73 nM) anytime while on androgen deprivation therapy 4. Evidence of disease progression on prior therapy or watchful waiting. Disease progression is defined by meeting at least one of the following criteria: 1. 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. 2. 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. 3. Soft tissue disease ONLY progression\* defined as the appearance of at least one new lesion (soft tissue). 4. Bone disease ONLY progression\* defined by two or more new lesions on bone scan. 5. 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 6. Able and willing to provide signed informed consent in French or English and to comply with protocol requirements. Exclusion Criteria: 1. Another non-cutaneous malignancy or melanoma diagnosed in the past 5 years; 2. Currently under a randomized-controlled trial with unknown allocation; 3. Limited survival prognosis (ECOG ≥3); 4. Patients under dialysis; 5. Any disease or condition limiting the patient's capacity to execute the study procedures, based on the investigators' opinion.
References
Publications (2)
- DERIVEDZamanian 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
- DERIVEDPouliot F, Saad F, Rousseau E, Richard PO, Zamanian A, Probst S, Levesque E, Castonguay V, Marcoux N, Lodde M, Juneau D, Hamilou Z, Lattouf JB, Buteau FA, Pavic M, Castilloux JF, Neveu B, Bouvet GF, Allard C, Tetu A, Guerin B, Beauregard JM; 3TMPO Investigators. Intrapatient Intermetastatic Heterogeneity Determined by Triple-Tracer PET Imaging in mCRPC Patients and Correlation to Survival: The 3TMPO Cohort Study. J Nucl Med. 2024 Nov 1;65(11):1710-1717. doi: 10.2967/jnumed.124.268020. PMID 39327017