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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: Male
Minimum Age: 30
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
IRCCS - Policlinico Universitario di Sant'Orsola
RECRUITING
Bologna
Contact Information
Primary
Michela Moscarino, Technician
michela.moscarino@aosp.bo.it
+390512143179
Time Frame
Start Date: 2025-02-03
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 244
Treatments
No_intervention: Control Group (A)
Participants will undergo the conventional \[⁶⁸Ga\]Ga-PSMA PET/CT protocol, which includes a standard whole-body PET/CT performed 60 minutes post-injection and a delayed pelvic PET/CT as per current clinical practice (PET + CT).
Experimental: Intervention Group (B)
Participants will undergo:~* Standard whole-body PET/CT at 60 minutes, followed by~* A delayed pelvic PET-only acquisition at 90 minutes, reconstructed using the CT obtained during the initial whole-body acquisition.
Related Therapeutic Areas
Sponsors
Leads: IRCCS Azienda Ospedaliero-Universitaria di Bologna

This content was sourced from clinicaltrials.gov