Delayed Pelvic Imaging With [68]Ga-PSMA PET/CT in a Patient With High-risk Prostate Cancer.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age30+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Intervention Group

Treatment groups

244 Participants
are divided into 2 treatment groups