High-risk Prostate CancerSPIR202302NCT07357259
Delayed Pelvic Imaging With [68]Ga-PSMA PET/CT in a Patient With High-risk Prostate Cancer.
A study testing Intervention Group in people with High-risk Prostate Cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older, men only
- Conditions the study is for
- High-risk Prostate Cancer
- What is being tested?
- Intervention Group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteItaly
- Study dates
- 3 Feb 2025to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS - Policlinico Universitario di Sant'Orsola
Bologna, Italy, 40138
Michela Moscarino, Technician, michela.moscarino@aosp.bo.it
About this study
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.
Read more
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.
Read the detailed description
This study evaluates a modified dual-phase [⁶⁸Ga]Ga-PSMA PET/CT protocol designed to reduce radiation exposure and streamline workflow while maintaining diagnostic quality in the assessment of prostate cancer. Conventional imaging often includes a standard whole-body PET/CT acquisition at approximately 60 minutes post-injection followed by a delayed pelvic PET/CT, which can provide additional lesion detectability but requires a second CT scan. The additional CT increases both radiation dose and examination duration.
The proposed protocol replaces the delayed CT with a PET-only pelvic acquisition performed 90 minutes post-injection. Delayed PET images are reconstructed and attenuation-corrected using the CT dataset obtained during the initial whole-body acquisition. This approach is feasible because pelvic structures relevant to prostate cancer-such as the prostate gland and pelvic lymph nodes-exhibit limited physiological motion compared with intraperitoneal organs, allowing reliable PET-CT anatomical correspondence through optimized patient repositioning.
The study adopts a randomized, two-arm design including patients undergoing staging for newly diagnosed prostate cancer or evaluation of biochemical recurrence. Randomization is stratified by prior radical prostatectomy to account for potential anatomical variability. The control arm follows the standard clinical workflow with both standard and delayed PET/CT acquisitions. The intervention arm undergoes standard whole-body PET/CT at 60 minutes and delayed PET-only imaging at 90 minutes.
Anatomical matching between delayed PET images and the CT dataset will be independently evaluated by three Medical Imaging Technologists (TSRM1, TSRM2, TSRM3) across three blinded reading sessions. Each rater will score image alignment using a standardized 1-5 Likert scale. The primary endpoint is the quality of PET-CT matching, assessed through Fleiss' kappa statistics to quantify interrater agreement and compare matching performance between the two imaging workflows.
Secondary objectives examine the potential reduction in radiation exposure, measured through CTDIvol and DLP values obtained from the CT Dose Report, and the impact on patient experience and departmental efficiency. Patient-perceived waiting time and comfort will be assessed through a short questionnaire administered after the examination, while objective in-department duration will be extracted from institutional scheduling records.
If effective, the streamlined protocol may support broader adoption of CT-free delayed pelvic imaging by demonstrating that optimized technologist-led positioning can maintain diagnostic interpretability while improving patient-centered outcomes and reducing overall radiation burden.
- Conditions
- High-risk Prostate Cancer
- Being tested
- Intervention Group
- Keywords
- PET/CT, [68]Ga - PSMA, Delay CT scan, Radiation Dose Optimization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupDiagnostic test
Matching of delayed PET images with the standard CT scan
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to completion of the study, on average 1 year.
Secondary outcomes (2)
Radiation Dose Optimization
Change in CTDIvol (Computed Tomography Dose Index volume) in the experimental arm. CTDIvol (mGy) will be used to assess changes in radiation dose related to the experimental protocol.
Unit of Measure:
Milligray (mGy)
Measured: Up to completion of study, on average 1 year.
Patient Throughput and Experience
Comparison of patient experience in the Nuclear Medicine Unit between the two study groups. Patient experience will be evaluated using a structured, patient-reported questionnaire at the end of the [68]Ga-PSMA PET/CT examination, based on the perceived quality of staff information regarding waiting times.
Unit of Measure:
- Patient experience: 5-level ordinal scale (Very poor → Excellent)
Measured: Up to completion of study, on average 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start3 Feb 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for High-risk Prostate CancerStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michela Moscarino, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- Michela Moscarino, Technician, Principal investigator, IRCCS Università di Bologna, Policlinico di Sant'Orsola
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07357259
- Sponsor's protocol ID
- SPIR202302
- Acronym
- SPIR202302
- Status last verified
- Nov 2025
- First submitted
- 4 Dec 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32998432Rahbar 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.
PubMed 29541812Haupt 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.
PubMed 31673789Derlin 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.
PubMed 27011373Beheshti 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.
PubMed 32060214Fonti 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.
PubMed 31378377Fanti 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.
PubMed 30507436Purohit 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.
PubMed 12735504Schroder 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.
PubMed 19297566
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed Pelvic Imaging With [68]Ga-PSMA PET/CT in a Patient With High-risk Prostate Cancer.
- ClinicalTrials.gov ID
- NCT07357259
- Acronym / sponsor ID
- SPIR202302 / SPIR202302
- Conditions
- High-risk Prostate Cancer
- Keywords
- PET/CT, [68]Ga - PSMA, Delay CT scan, Radiation Dose Optimization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study evaluates a modified dual-phase [⁶⁸Ga]Ga-PSMA PET/CT protocol designed to reduce radiation exposure and streamline workflow while maintaining diagnostic quality in the assessment of prostate cancer. Conventional imaging often includes a standard whole-body PET/CT acquisition at approximately 60 minutes post-injection followed by a delayed pelvic PET/CT, which can provide additional lesion detectability but requires a second CT scan. The additional CT increases both radiation dose and examination duration.
The proposed protocol replaces the delayed CT with a PET-only pelvic acquisition performed 90 minutes post-injection. Delayed PET images are reconstructed and attenuation-corrected using the CT dataset obtained during the initial whole-body acquisition. This approach is feasible because pelvic structures relevant to prostate cancer-such as the prostate gland and pelvic lymph nodes-exhibit limited physiological motion compared with intraperitoneal organs, allowing reliable PET-CT anatomical correspondence through optimized patient repositioning.
The study adopts a randomized, two-arm design including patients undergoing staging for newly diagnosed prostate cancer or evaluation of biochemical recurrence. Randomization is stratified by prior radical prostatectomy to account for potential anatomical variability. The control arm follows the standard clinical workflow with both standard and delayed PET/CT acquisitions. The intervention arm undergoes standard whole-body PET/CT at 60 minutes and delayed PET-only imaging at 90 minutes.
Anatomical matching between delayed PET images and the CT dataset will be independently evaluated by three Medical Imaging Technologists (TSRM1, TSRM2, TSRM3) across three blinded reading sessions. Each rater will score image alignment using a standardized 1-5 Likert scale. The primary endpoint is the quality of PET-CT matching, assessed through Fleiss' kappa statistics to quantify interrater agreement and compare matching performance between the two imaging workflows.
Secondary objectives examine the potential reduction in radiation exposure, measured through CTDIvol and DLP values obtained from the CT Dose Report, and the impact on patient experience and departmental efficiency. Patient-perceived waiting time and comfort will be assessed through a short questionnaire administered after the examination, while objective in-department duration will be extracted from institutional scheduling records.
If effective, the streamlined protocol may support broader adoption of CT-free delayed pelvic imaging by demonstrating that optimized technologist-led positioning can maintain diagnostic interpretability while improving patient-centered outcomes and reducing overall radiation burden.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Diagnostic Test: Intervention GroupParticipants 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention GroupMatching of delayed PET images with the standard CT scan | Diagnostic test | Intervention Group (B) |
Primary outcome
Matching Quality of Delayed PET with Standard CT
Time frame: Up to completion of the study, on average 1 year.
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)
2 secondary outcomes
Radiation Dose Optimization
Time frame: Up to completion of study, on average 1 year.
Patient Throughput and Experience
Time frame: Up to completion of study, on average 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Background: PubMed 32998432Hoffmann 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.
- Background: PubMed 29541812Rahbar 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.
- Background: PubMed 31673789Haupt 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.
- Background: PubMed 27011373Derlin 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.
- Background: PubMed 32060214Beheshti 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.
- Background: PubMed 31378377Fonti 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.
- Background: PubMed 30507436Fanti 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.
- Background: PubMed 12735504Purohit 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.
- Background: PubMed 19297566Schroder 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michela Moscarino, Technician principal investigator
IRCCS Università di Bologna, Policlinico di Sant'Orsola
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with High-risk Prostate Cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michela Moscarino, Technician (+390512143179, michela.moscarino@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Matching Quality of Delayed PET with Standard CT (time frame: Up to completion of the study, on average 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07357259, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.