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

NCT06167824 | Completed DMC

• 1 other identifier: PETCT-CHOL-SURVIVAL-TREATMENT
• Study Type: observational
• Target: 302
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

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

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

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients previously treated with radical prostatectomy, with progressive increase in PSA value in the absence of hormonal therapy and for whom there is knowledge of the main clinical and follow up data with particular attention to survival data.

You may qualify if:

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

You may not qualify if:

• \< 18 years patients

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

Irccs San Raffaele

Milan, Italia, Italy

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Diagnostic Imaging and Radiotherapy Faculty of Medicine and Surgery, Vita-Salute San Raffaele University Director, Department of Nuclear Medicine, IRCCS Ospedale San Raffaele

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 13, 2023
• Study Start: June 19, 2014
• Primary Completion: July 15, 2014
• Study Completion: July 15, 2014
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)