Delayed pelvic [68Ga]-PSMA PET/CT using the first CT for men with high-risk prostate cancer

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

This test tries to see if doing a delayed pelvic [68Ga]-PSMA PET that reuses the initial CT (so no second CT) keeps image quality while lowering radiation for men with high‑risk or recurrent prostate cancer.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 244 (estimated)
• Ages: 30 Years and up
• Sex: Male
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna (other)
• Drugs / interventions: radiation
• Locations: 1 site (Bologna, Italy)
• Trial ID: NCT07357259 on ClinicalTrials.gov

What this trial studies

This randomized two-arm study enrolls men undergoing staging for newly diagnosed high-risk prostate cancer or evaluation for biochemical recurrence and stratifies randomization by prior radical prostatectomy. The control arm follows standard whole-body PET/CT at about 60 minutes post-injection plus a delayed pelvic PET/CT with a second CT, while the intervention arm receives the standard whole-body PET/CT at 60 minutes and a delayed pelvic PET-only acquisition at 90 minutes that is reconstructed using the original CT for attenuation correction. The protocol relies on limited pelvic motion and careful patient repositioning to maintain PET–CT anatomical correspondence without repeating the CT. The main goal is to determine whether the PET-only delayed approach preserves diagnostic quality while reducing radiation exposure and total scan time.

Who should consider this trial

Good fit: Men with newly diagnosed high-risk prostate cancer (for example Gleason ≥8 or PSA ≥20 ng/mL) or men with biochemical recurrence after prior radical-intent therapy who can provide informed consent and tolerate PET/CT are ideal candidates.

Not a fit: Patients with intermediate- or low-risk disease, significant genitourinary conditions that compromise imaging, those who require a repeat CT because of artifacts or different scanners, or those unable to consent or cooperate with imaging are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the protocol could lower patient radiation dose and shorten exam time while preserving the ability to detect pelvic prostate cancer lesions.

How similar studies have performed: Prior work has shown that delayed [68Ga]-PSMA imaging can reveal additional lesions, but using a delayed PET-only acquisition reconstructed with an earlier CT is a newer workflow that is being tested for safety and accuracy.

Eligibility criteria

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 this trial is running

Bologna, Italy

• IRCCS - Policlinico Universitario di Sant'Orsola — Bologna, Italy, Italy (RECRUITING)

Study contacts

• Principal investigator: Michela Moscarino, Technician — IRCCS Università di Bologna, Policlinico di Sant'Orsola
• Study coordinator: Michela Moscarino, Technician

Conditions: High-risk Prostate Cancer, PET/CT, [68]Ga - PSMA, Delay CT scan, Radiation Dose Optimization