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Use of 64CuCl2 PET/CT Imaging in the selection of patients with prostate cancer in biochemical relapse after prostatectomy, to be successfully treated with salvage radiotherapy on the prostatic bed.

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-520868-17-00
Acronym
P.64Cu.002.02
Enrollment
138
Registered
2025-02-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer on the prostatic bed

Brief summary

To evaluate the relationship between PSA levels (calculated between PSA levels measured before treatment and minimum PSA level measured during the observational period following the treatment) and prostatic bed (positive prostate (B +) and negative prostate (B-). The 64CuCl2-PET is obtained positive (B +) when in the prostate bed a detectable focal absorption is manifested because superior to the value of the background; otherwise it is judged negative (B-).

Detailed description

Calculation of the maximum variation of PSA in the subgroups of patients with PSA<0.5 and PSA between 0.5 and 1, through the ROC curve and evaluation of the ability to detect sites of recurrence., In each patient the impact that the positive results of 64CuCl2-PET out of the prostatic bed would have had on the therapeutic choice will be evaluated and tabulated, also taking into account the classification of the patient in R+/R-;, Sensitivity, specificity, positive and negative predictive values and area under the curve (AUC) will be evaluated., The time between treatment beginning (baseline) and the achievement of the minimum value (NADIR) will be estimated through estimates of Kaplan-Meyer curves., The SUV values of the prostate bed index lesions will be correlated with the actual SRT response, in order to identify the SUV limits below which the uptake is not significant., Adverse events will be recorded and classified according to the EMA guidelines.

Interventions

Sponsors

A.C.O.M. Advanced Center Oncology Macerata S.r.l.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
To evaluate the relationship between PSA levels (calculated between PSA levels measured before treatment and minimum PSA level measured during the observational period following the treatment) and prostatic bed (positive prostate (B +) and negative prostate (B-). The 64CuCl2-PET is obtained positive (B +) when in the prostate bed a detectable focal absorption is manifested because superior to the value of the background; otherwise it is judged negative (B-).

Secondary

MeasureTime frame
Calculation of the maximum variation of PSA in the subgroups of patients with PSA<0.5 and PSA between 0.5 and 1, through the ROC curve and evaluation of the ability to detect sites of recurrence., In each patient the impact that the positive results of 64CuCl2-PET out of the prostatic bed would have had on the therapeutic choice will be evaluated and tabulated, also taking into account the classification of the patient in R+/R-;, Sensitivity, specificity, positive and negative predictive values and area under the curve (AUC) will be evaluated., The time between treatment beginning (baseline) and the achievement of the minimum value (NADIR) will be estimated through estimates of Kaplan-Meyer curves., The SUV values of the prostate bed index lesions will be correlated with the actual SRT response, in order to identify the SUV limits below which the uptake is not significant., Adverse events will be recorded and classified according to the EMA guidelines.

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026