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

NCT07357259 | Recruiting

• 1 other identifier: SPIR202302
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

High-risk Prostate Cancer

Keywords

PET/CT; [68]Ga - PSMA; Delay CT scan; Radiation Dose Optimization

Outcome Measures

Primary Outcomes (1)

• Matching Quality of Delayed PET with Standard CT

  Evaluation of the actual matching accuracy between delayed PET images-reconstructed and attenuation-corrected using the dedicated CT/AC dataset-and the standard CT scan within the new procedural approach to \[68\]Ga-PSMA PET/CT. Three Technologist of Medical Imaging (TSRM1, TSRM2, TSRM3) will evaluate the images independently, in a blinded manner, at three separate time points (t1, t2, t3). The registration accuracy between delayed PET images and the standard CT scan will be evaluated using a qualitative questionnaire based on the evaluators' professional experience (minimum of five years in Nuclear Medicine). Image registration will be scored on a 5-point ordinal scale, ranging from 1 (complete mismatch) to 5 (perfect registration). Unit of Measure: 5-point ordinal scale (1-5)

  Up to completion of the study, on average 1 year.

Secondary Outcomes (2)

• Radiation Dose Optimization

  Up to completion of study, on average 1 year.

• Patient Throughput and Experience

  Up to completion of study, on average 1 year.

Other Outcomes (3)

• Radiation Dose Optimization

  Up to completion of the study, on average 1 year.

• Radiation Dose Optimization

  Up to completion of the study, on average 1 year.

• Patient Throughput and Experience

  Up to completion of the study, on average 1 year

Study Arms (2)

Control Group (A)

NO INTERVENTION

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).

Intervention Group (B)

EXPERIMENTAL

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.

Diagnostic Test: Intervention Group

Interventions

Intervention Group DIAGNOSTIC_TEST

Matching of delayed PET images with the standard CT scan

Intervention Group (B)

Eligibility Criteria

• Age: 30 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS - Policlinico Universitario di Sant'Orsola

Bologna, Italy, 40138, Italy

RECRUITING

Related Publications (9)

• Hoffmann MA, Buchholz HG, Wieler HJ, Rosar F, Miederer M, Fischer N, Schreckenberger M. Dual-Time Point [68Ga]Ga-PSMA-11 PET/CT Hybrid Imaging for Staging and Restaging of Prostate Cancer. Cancers (Basel). 2020 Sep 28;12(10):2788. doi: 10.3390/cancers12102788.

  PMID: 32998432 BACKGROUND

• Rahbar K, Afshar-Oromieh A, Bogemann M, Wagner S, Schafers M, Stegger L, Weckesser M. 18F-PSMA-1007 PET/CT at 60 and 120 minutes in patients with prostate cancer: biodistribution, tumour detection and activity kinetics. Eur J Nucl Med Mol Imaging. 2018 Jul;45(8):1329-1334. doi: 10.1007/s00259-018-3989-0. Epub 2018 Mar 14.

  PMID: 29541812 BACKGROUND

• Haupt F, Dijkstra L, Alberts I, Sachpekidis C, Fech V, Boxler S, Gross T, Holland-Letz T, Zacho HD, Haberkorn U, Rahbar K, Rominger A, Afshar-Oromieh A. 68Ga-PSMA-11 PET/CT in patients with recurrent prostate cancer-a modified protocol compared with the common protocol. Eur J Nucl Med Mol Imaging. 2020 Mar;47(3):624-631. doi: 10.1007/s00259-019-04548-5. Epub 2019 Nov 1.

  PMID: 31673789 BACKGROUND

• Derlin T, Weiberg D, von Klot C, Wester HJ, Henkenberens C, Ross TL, Christiansen H, Merseburger AS, Bengel FM. 68Ga-PSMA I&T PET/CT for assessment of prostate cancer: evaluation of image quality after forced diuresis and delayed imaging. Eur Radiol. 2016 Dec;26(12):4345-4353. doi: 10.1007/s00330-016-4308-4. Epub 2016 Mar 24.

  PMID: 27011373 BACKGROUND

• Beheshti M, Manafi-Farid R, Geinitz H, Vali R, Loidl W, Mottaghy FM, Langsteger W. Multiphasic 68Ga-PSMA PET/CT in the Detection of Early Recurrence in Prostate Cancer Patients with a PSA Level of Less Than 1 ng/mL: A Prospective Study of 135 Patients. J Nucl Med. 2020 Oct;61(10):1484-1490. doi: 10.2967/jnumed.119.238071. Epub 2020 Feb 14.

  PMID: 32060214 BACKGROUND

• Fonti R, Conson M, Del Vecchio S. PET/CT in radiation oncology. Semin Oncol. 2019 Jun;46(3):202-209. doi: 10.1053/j.seminoncol.2019.07.001. Epub 2019 Jul 26.

  PMID: 31378377 BACKGROUND

• Fanti S, Minozzi S, Antoch G, Banks I, Briganti A, Carrio I, Chiti A, Clarke N, Eiber M, De Bono J, Fizazi K, Gillessen S, Gledhill S, Haberkorn U, Herrmann K, Hicks RJ, Lecouvet F, Montironi R, Ost P, O'Sullivan JM, Padhani AR, Schalken JA, Scher HI, Tombal B, van Moorselaar RJA, Van Poppel H, Vargas HA, Walz J, Weber WA, Wester HJ, Oyen WJG. Consensus on molecular imaging and theranostics in prostate cancer. Lancet Oncol. 2018 Dec;19(12):e696-e708. doi: 10.1016/S1470-2045(18)30604-1.

  PMID: 30507436 BACKGROUND

• Purohit RS, Shinohara K, Meng MV, Carroll PR. Imaging clinically localized prostate cancer. Urol Clin North Am. 2003 May;30(2):279-93. doi: 10.1016/s0094-0143(02)00184-2.

  PMID: 12735504 BACKGROUND

• Schroder FH, Hugosson J, Roobol MJ, Tammela TL, Ciatto S, Nelen V, Kwiatkowski M, Lujan M, Lilja H, Zappa M, Denis LJ, Recker F, Berenguer A, Maattanen L, Bangma CH, Aus G, Villers A, Rebillard X, van der Kwast T, Blijenberg BG, Moss SM, de Koning HJ, Auvinen A; ERSPC Investigators. Screening and prostate-cancer mortality in a randomized European study. N Engl J Med. 2009 Mar 26;360(13):1320-8. doi: 10.1056/NEJMoa0810084. Epub 2009 Mar 18.

  PMID: 19297566 BACKGROUND

Study Officials

• Michela Moscarino, Technician

  IRCCS Università di Bologna, Policlinico di Sant'Orsola

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michela Moscarino, Technician

CONTACT

+390512143179; michela.moscarino@aosp.bo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: January 21, 2026
• Study Start: February 3, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 21, 2026

Record last verified: 2025-11

Locations

IT (1)