Biopsy diagnosis of prostate cancer in patients with suspected prostate cancer undergoing their first biopsy: comparison of target biopsy alone vs target biopsy in addition to standard biopsy

Biopsy diagnosis of prostate cancer in naïve patients. Comparison of target biopsy alone vs. target biopsy in addition to random: a prospective randomized trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN60263108

Enrollment

384

Registered

2022-03-09

Start date

2019-04-11

Completion date

Unknown

Last updated

2023-01-23

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

Conditions

Prostate cancer Cancer Malignant neoplasm of prostate

Interventions

The primary objective of the study is to compare, in naïve patients with positive MRI, the detection rate of clinically significant prostate cancer of a diagnostic pathway based on target biopsy sampl

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Age <75 years 2. Negative history of previous prostate biopsies 3. Suspected serum prostate-specific antigen (PSA) values <15 ng/ml 4. Negative rectal examination (DRE) 5. Positive multiparametric magnetic resonance imaging

Exclusion criteria

Exclusion criteria: Contraindications to prostate biopsy (e.g., inability to discontinue anticoagulant therapy)

Design outcomes

Primary

Measure	Time frame
Detection rate (DR) of clinically significant prostate cancer (csPCa) by fusion biopsy alone (Group A) versus fusion biopsy plus standard biopsy (Group B), set as the ratio between the total cases of csPCs diagnosed and the total number of patients. Evaluated after the histological examination.	—

Secondary

Measure	Time frame
1. 30-days biopsy related complications classified according to the Clavien–Dindo classification at 30-days follow up 2. The overall DR of prostate cancer by fusion biopsy alone (Group A) versus fusion biopsy plus standard biopsy (Group B). Evaluated after the histological examination. 3. Whole-mount histopathological findings after RARP compared with biopsy findings in both study groups, evaluated after the histological examination	—

Measure

Time frame

1. 30-days biopsy related complications classified according to the Clavien–Dindo classification at 30-days follow up 2. The overall DR of prostate cancer by fusion biopsy alone (Group A) versus fusion biopsy plus standard biopsy (Group B). Evaluated after the histological examination. 3. Whole-mount histopathological findings after RARP compared with biopsy findings in both study groups, evaluated after the histological examination

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Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 12, 2026