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Taking people in ItalyNo phase

Delayed pelvic PET scan with a PSMA tracer in high-risk prostate cancer

Tests a second, pelvis-only PET scan after the first in prostate cancer.

Plain-language title generated from the registry record
Registry title: Delayed Pelvic Imaging With [68]Ga-PSMA PET/CT in a Patient With High-risk Prostate Cancer.

Key facts

Where
Bologna, ItalySee the site

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for men with newly diagnosed, high-risk or recurrent prostate cancer. It tests a PSMA PET/CT scan with an extra delayed scan of the pelvis.

Age
30 years or older
Sex
Men only
Disease stage
Newly diagnosed prostate cancer being staged, or cancer that came back after surgery and/or radiotherapy, or high-risk prostate cancer (Gleason Score ≥ 8 or PSA ≥ 20 ng/mL)
Earlier treatment
For recurrence: earlier surgery and/or radiotherapy given to try to remove or destroy the cancer

Main reasons for not taking part

  • Urinary or genital conditions that could disturb the scan or its reading
  • Intermediate- or low-risk prostate cancer
  • Cannot give informed consent or has impaired decision-making capacity
  • Known allergy to the scan tracer or its components
  • Cannot have a PET/CT scan (for example severe claustrophobia, morbid obesity, cannot cooperate)

Read by machine on 13 November 2026.

Where in Italy

  • IRCCS - Policlinico Universitario di Sant'OrsolaBologna, ItalyContact: Michela MoscarinoTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Trial code
NCT07357259
Record updated
21 January 2026
Original description
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:Read full original descriptionShow less

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

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.

Inclusion: 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: Patients previously enrolled who require repeat PET/CT as a new visit; Intermediate- or low-risk prostate cancer; Known hypersensitivity to the radiopharmaceutical or its components; Genitourinary comorbidities that could interfere with imaging or interpretation; 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); Inability to provide informed consent or impaired decision-making capacity; Contraindications to PET/CT (e.g., severe claustrophobia, morbid obesity, inability to cooperate).

ClinicalTrials.gov NCT07357259