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OpenTrials
Completed

NCT Number: NCT06167824

Assessment of Predictive Role of [11C] Choline PET/CT on Survival in Prostate Cancer Patients With Biochemical Failure Without Androgen Deprivation Therapy

Among all the patients who underwent PET/CT with choline at our Institute between 2004 and 2007 to restage the prostatic disease following biochemical recovery of the disease, in this retrospective study the patients previously treated with radical prostatectomy, who present a progressive increase in the PSA value in the absence of hormone therapy and of which there is knowledge of the main clinical and follow-up data, with particular attention to survival data.

The PET/CT study with Choline, being part of the normal standard diagnostic work-up of patients, was performed following the normal clinical protocol. With the retrospective analysis of the data, the time elapsed following the prostatectomy operation and the follow-up time after the Choline PET/CT study will be evaluated and patients who died due to prostate cancer will therefore be considered. Prostate cancer-specific survival, calculated as the interval between radical prostatectomy and death due to prostate cancer, will be used as the end point. The differences between prostate cancer-specific survival of patients with a positive choline PET/CT study and patients with a negative choline PET/CT study will be evaluated (log-rank test). Choline PET/CT will be considered positive if pathological findings with significant tracer uptake are identified. In the subpopulation of patients with a positive Choline PET/CT study, survival data will also be evaluated in relation to the site of positivity of the PET/CT study, in particular at the level of local recurrence, in the lymph node or skeletal site.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Irccs San Raffaele

Milan, Italia, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients previously treated with radical prostatectomy, with progressive increase in PSA value in the absence of hormonal therapy.

Exclusion criteria

  • < 18 years patients

Treatment and study plan

Primary outcomes

  1. PET/CT with coline in patients previously treated with radical prostatectomy.

    Time frame: 1 year

    Retrospective observational study with 302 patients with prostate cancer were considered.

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Dec 13, 2023
Registry last updated
Dec 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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