Clinical trial · Interventional
Delayed Pelvic Imaging With [68]Ga-PSMA PET/CT in a Patient With High-risk Prostate Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High-risk Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intervention Group | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control Group (A)
- description
- 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).
- type
- EXPERIMENTAL
- label
- Intervention Group (B)
- description
- 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.
- interventionNames
- Diagnostic Test: Intervention Group
Primary outcomes (1)
- measure
- Matching Quality of Delayed PET with Standard CT
- timeFrame
- Up to completion of the study, on average 1 year.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 30 Years
Show eligibility criteria text
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).
References
Publications (9)
- BACKGROUNDHoffmann 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
- BACKGROUNDRahbar 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
- BACKGROUNDHaupt 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
- BACKGROUNDDerlin 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
- BACKGROUNDBeheshti 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
- BACKGROUNDFonti 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.