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

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 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.

Why it matters

Who can join: the full rules

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's running

• 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
• Email: michela.moscarino@aosp.bo.it
• Phone: +390512143179

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.