NCT07357259Recruiting
Delayed Pelvic Imaging With [68]Ga-PSMA PET/CT in a Patient With High-risk Prostate Cancer.
Source: ClinicalTrials.gov · Last updated 21 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 244 (estimated)
- First submitted
- 4 Dec 2025
- Start date
- 3 Feb 2025
- Primary completion date
- 1 Mar 2026
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Diseases
- Prostate cancer
- NCT number
- NCT07357259
What you commit to
- Study type: Interventional
- Planned participants: 244
- From 3 Feb 2025 to the primary completion date, 1 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients previously enrolled who require repeat PET/CT as a new visit.
Other illness
- Intermediate- or low-risk prostate cancer.
- Known hypersensitivity to the radiopharmaceutical or its components.
Other
- 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).
Who the study is looking for
- 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.
Age in the registry: 30 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS - Policlinico Universitario di Sant'Orsola Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.