Use of [-2]proPSA for the detection of prostate cancer in patients who are candidate for prostatic biopsy

Conditions

Prostate cancer Cancer Malignant neoplasm of prostate

Giovanni Lughezzani, Massimo Lazzeri, Rodolfo Hurle, Nicolò Maria Buffi, Paolo Casale et al. (16 authors)

The Journal of Urology2016-03-28

10.1016/j.juro.2016.02.1873

Clinical performance of the Prostate Health Index (PHI) for the prediction of prostate cancer in obese men: data from the PROMEtheuS project, a multicentre European prospective study.

Abrate A, Lazzeri M, Lughezzani G, Buffi N, Bini V, Haese A, de la Taille A, McNicholas T, Redorta JP, Gadda GM, Lista G, Kinzikeeva E, Fossati N, Larcher A, Dell'Oglio P, Mistretta F, Freschi M, Guazzoni G.

2015-04-0123 citations

10.1111/bju.12907

MP74-09 P2PSA AND DERIVATIVES (%P2PSA AND PHI) ACCURATELY PREDICT PROSTATE CANCER IN OBESE MEN FROM A MULTICENTER PROSPECTIVE EUROPEAN STUDY

Alberto Abrate, Massimo Lazzeri, Nicolò Maria Buffi, Alexander Haese, Alexandre de la Taille et al. (19 authors)

The Journal of Urology2014-03-28

10.1016/j.juro.2014.02.2342

Interventions

For each patients included, as part of the standard care at each institution, blood will be drawn and serum (blood centrifuged and serum collected) will be prepared within 3 hours of the blood draw. T

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Male patients older than 45 years old 2. Negative/positive digital rectal examination 3. Patients subjected to previous prostate biopsy will be included and analyzed in a nested case control study 4. Patients treated with drugs that may alter serum PSA levels (Finasteride and Dutasteride) will be included and analysed later in a nested case control study

Exclusion criteria

Exclusion criteria: 1. Patients with bacterial acute prostatitis and with a positive sperm culture in the last three months prior to biopsy 2. Patients subjected to previous endoscopic surgery of the prostate (TransUrethral Resection of the Prostate [TURP] or Holmium-laser Enucleomorcellation of the Prostate [HoLEP]

Design outcomes

Primary

Measure	Time frame
Evaluate the specificity, sensitivity and diagnostic accuracy of -2proPSA and its derivatives (index text) in determining the presence of PCa at prostate biopsy and to compare them with those of total and free PSA (referenced text). Thus, we will quantify the number of prostate biopsies that can be spared using -2proPSA in the prostate biopsy decision path.	—

Secondary

Measure	Time frame
1. Determine a -2proPSA (and its derivatives) cut-off value to be used in clinical practice 2. Determine the relationship between -2proPSA (and its derivatives) and PCa characteristics at biopsy (e.g. Gleason grade, % of cores involved, % of involvement of a single core)	—

Countries

France, Germany, Italy, Spain, United Kingdom

Outcome results

None listed