Recruiting

Molecular Imaging

Sponsor:

Frederic Pouliot

Code:

NCT07302763

Conditions

mCRPC (Metastatic Castration-resistant Prostate Cancer)

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PET Tracer

Study Details

Brief summary:

Imaging modalities currently used in the clinics do not image cancer, but the effect ofncancer on bone (bone scan) or on the anatomy (CT-scan). Bone scan and CT-scan are therefore named conventional imaging (CI) modalities. Positron Emission Tomography (PET) is an imaging technique that uses tracers to measure cancer activity in each lesion and is therefore quantitative. Usually, treatment changes in metastatic prostate cancers are based on the appearance of new lesions on CI, named metastases. Prostate cancer metastases have been shown to be clonal, which means that there are several cancers within each patient, potentially with divergent behaviors under therapy. In other words, some metastases might be resistant to a systemic therapy like chemotherapy, while others might be sensitive. The study proposes here to use molecular imaging by positron emission tomography to image and quantify the activity of prostate cancer cells in each metastasis before start, after 3 months and after progression during systemic therapy.

Each metastasis will then be measured to assess whether there is an increase (resistance) or a decrease (response) in prostate cancer cell activity. The analysis will determine how many metastases progress or remain stable when new metastases appear on conventional imaging (polyclonal resistance), as well as the impact of a change in therapy on metastases that were previously stable when cancer progressed elsewhere. In addition, the genes expressed in responding and non-responding metastases will be analyzed to identify gene expression patterns associated with resistance and/or response. Overall, this study aims to characterize metastatic prostate cancer clonal resistance mechanisms using serial PET molecular imaging and imaging-guided genomics.

Conditions

mCRPC (Metastatic Castration-resistant Prostate Cancer)

Study ID

NCT07302763

Start date

Nov 4, 2025

Status verified date

Nov, 2025

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Assign male at birth, any gender ≥ 18 years old;
2. Histologically or cytologically proven adenocarcinoma of the prostate;
3. Metastatic disease documented by at least 3 metastatic active lesions\*, \*\* on whole body bone scan and/or measurable soft tissue on CT-scan (lymph nodes and visceral lesions);
4. CRPC \& post-androgen receptor pathway inhibitor (ARPI) defined by progression under continuous castration (measured serum testosterone ≤50 ng/dL \[1.73 nM\]) AND an ARPI (darolutamide, apalutamide, enzalutamide or abiraterone acetate);
5. Eligible for taxane chemotherapy or PSMA-radioligand therapy (before imaging); 6-Able and willing to provide signed informed consent and to comply with protocol requirements.

  • Metastatic lesions on imaging are defined either: ≥ 10 mm on CT scan or caliper (for lymph nodes, see below), ≥ 20 mm on chest X-ray, lymph node ≥ 10 mm or having grown by ≥ 5 mm from baseline CT, any metastasis described on bone scan counts as a lesion. Of note: A bone lesion that has been treated by radiation is excluded from the lesions counted in the criterion of ≥ 3 lesions.

  • The reference imaging (scan with 3 metastases) confirming eligibility must be done either: 1) after biochemical progression on treatment OR 2) ≥ 90 days after last treatment has begun if imaging was performed while patient was still responding (to avoid disappearance of metastasis due to response).

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-Any disease or condition limiting the patient's capacity to execute the study procedures, based on the investigators' opinion;

Study Design

Enrollment

45 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: PET with FDG, PSMA and DOTATATE

Interventions

PET Tracer

Multi-tracer PET imaging to characterize metastatic prOstate Cancer heterogeneity

Primary outcome measure

  • Determine the change in prevalence of IIH of mCRPC undergoing consecutive lines of systemic therapy. [ Time Frame: At Baseline and at the date of first and second documented progression, assessed up to 60 months ]
  • Determine intrapatient intermetastasis therapeutic heterogeneous response (IIHR) in mCRPC patients. [ Time Frame: At the date of first and second documented progression, assessed up to 60 months ]

Central Contacts and Locations

Central contacts

Marie-Christine Dubé, PhD

418-525-4444marie-christine.dube@crchudequebec.ulaval.ca

Locations

CHU de Québec-Université Laval

Recruiting

Québec, Quebec, Canada, G1J1Z4

Contacts

Marie-Christine Dubé, PhD

418-525-4444marie-christine.dube@crchudequebec.ulaval.ca

Principal Investigator:

Frédéric Pouliot, MD, PhD

More Information

Sponsor

Frederic Pouliot

Last update posted

Dec 24, 2025

Last verified

Nov, 2025

Keywords

  • oncology
  • molecular imaging tracers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Frederic Pouliot on 2025-12-24.