Four-timepoint PET scans with three tracers to map differences between prostate cancer metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, single-arm imaging study will enroll 45 participants with metastatic castration‑resistant prostate cancer and at least three metastatic lesions. Participants will receive multi-tracer PET/CT imaging with 18F‑FDG, a PSMA tracer (68Ga or 18F chosen at the first PSMA scan and kept for consistency), and 68Ga‑DOTATATE at multiple timepoints to quantify lesion-level phenotypes and monitor changes over time. Required reference imaging includes conventional bone scan or 18F‑Na PET/CT plus CT/MRI (or 18F‑FDG‑PET/CT), and scans will be compared across visits to characterize intra-patient heterogeneity and phenotypic plasticity. The trial is planned at up to four Canadian sites, led by CHU de Québec‑Université Laval, with sequential competitive enrollment.

Why it matters

Who can join: the full rules

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;

Where it's running

• CHU de Québec-Université Laval
  Québec, Quebec, Canada Recruiting

Study contacts

• Principal investigator: Frédéric Pouliot, MD, PhD — CHU de Québec-Université Laval
• Study coordinator: Marie-Christine Dubé, PhD
• Email: marie-christine.dube@crchudequebec.ulaval.ca
• Phone: 418-525-4444

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.