Delayed Pelvic Imaging With [68]Ga-PSMA PET/CT in a Patient With High-risk Prostate Cancer.
Recruiting · NCT07357259 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Recent evidence suggests that both standard-time and delayed-time \[⁶⁸Ga\]Ga-PSMA PET acquisitions can reveal clinically relevant findings, and neither phase should be excluded a priori in routine practice. This study evaluates a streamlined dual-phase protocol consisting of: * A standard whole-body PET/CT acquisition performed 60 minutes after radiotracer administration. * A delayed pelvic PET-only acquisition performed 90 minutes post-injection, reconstructed using the attenuation-correction CT (CT/AC) obtained from the initial whole-body scan. Because the prostate gland and pelvic lymph nodes exhibit minimal physiological mobility, accurate PET-CT anatomical correspondence can be maintained through careful patient repositioning, without repeating the CT scan. The main advantage of this protocol is a reduction in patient radiation exposure, as the delayed phase does not require a second CT scan. It also reduces in-department time and maintains diagnostic quality of PET interpretation, provided that the PET-CT alignment remains acceptable. This method may additionally enhance workflow efficiency in the Nuclear Medicine Unit by allowing early identification-based on predefined clinical parameters-of patients most likely to benefit from delayed pelvic imaging.
Who can take part
Inclusion criteria
- Newly diagnosed prostate cancer undergoing staging, or
- Biochemical recurrence following prior radical-intent therapy (surgery and/or radiotherapy), or
- High-risk prostate cancer, defined as Gleason Score ≥ 8 or PSA ≥ 20 ng/mL.
- Written informed consent and authorization for personal data processing.
Exclusion criteria
- Genitourinary comorbidities that could interfere with imaging or interpretation.
- Intermediate- or low-risk prostate cancer.
- Delayed acquisition performed on a PET/CT scanner different from the standard acquisition.
- Additional PET/CT required due to artifacts compromising diagnostic quality (e.g., urinary retention, excessive motion).
- Patients previously enrolled who require repeat PET/CT as a new visit.
- Inability to provide informed consent or impaired decision-making capacity.
- Known hypersensitivity to the radiopharmaceutical or its components.
- Contraindications to PET/CT (e.g., severe claustrophobia, morbid obesity, inability to cooperate).
Where it is running
1 location listed.
- IRCCS - Policlinico Universitario di Sant'Orsola - Bologna, Italy, Italy