What is the initial evaluation and management of a patient with suspected prostate cancer?

Initial Evaluation and Management of Suspected Prostate Cancer

The initial evaluation of a patient with suspected prostate cancer should include digital rectal examination, PSA testing, and transrectal ultrasound-guided biopsies, with at least six systematic biopsies targeting particularly the posterior zone of the prostate. 1

Diagnostic Approach

Digital Rectal Examination (DRE)

• Any abnormality detected during DRE suggestive of prostate cancer in the absence of infection should be investigated further with a transrectal ultrasound-guided biopsy, even if the PSA concentration is normal 1
• DRE has shown higher recall rates for peripheral zone tumors (65.50%) compared to central or transition zone tumors (34.55%) 2
• DRE-positive findings significantly correlate with higher Gleason scores (≥7) and more aggressive disease 2

PSA Testing

• Total serum PSA determination (upper limit of reference range: 4 ng/mL) remains the reference test for screening and primary indication for biopsy 1
• A lower upper limit of the reference range (between 2-4 ng/mL) can be used in men under 65 years old or those at higher risk 1
• Repeated PSA determinations should be performed by the same laboratory using the same technique 1
• PSA density adjustment using age and prostatic volume has not been validated against the decision to perform biopsies 1

Prostatic Biopsy

• A definitive diagnosis of prostate cancer is made following histopathological examination of prostatic biopsy samples 1
• For potentially curative situations, at least six systematic transrectal ultrasound-guided biopsies should be performed, particularly sampling the posterior zone 1
• Rectal preparation by enema and prophylactic antibiotics effective against Gram-negative bacteria should be administered to prevent infectious complications 1
• The patient must be informed about the risks of the procedure and provided with emergency contact information 1
• Biopsies can be performed in day-hospital or outpatient settings, usually with local anesthesia 1

Pre-Biopsy Preparation

• Explain the aim and practical aspects of the biopsy to the patient 1
• Administer rectal preparation by enema 1
• Provide prophylactic antibiotics effective against Gram-negative bacteria 1
• Obtain informed consent after discussing risks and complications 1

Histopathological Assessment

• The pathology report should specify: histological type, percentage of Gleason grades 4 or 5, Gleason score, proportion of involved cores, and any extraprostatic extension 1
• Optional information includes: perineural invasion, vascular invasion, PIN foci, post-therapeutic changes, atypical adenomatous hyperplasia, and benign hypertrophy 1

Management After Initial Biopsy

Positive Biopsy Result

• Further staging should be performed to guide treatment decisions 1
• Digital rectal examination and transrectal ultrasound should be performed prior to, and used as a guide for, biopsies of the periprostatic tissue and seminal vesicles 1
• A renal ultrasound and CT scan should be performed for patients with stage T3 cancer 1
• Abdominal and pelvic CT scan should be performed in patients with T2a stage disease or higher, PSA concentration greater than 15 ng/mL, and a Gleason score of at least 7 1
• Bone scan is indicated if PSA >10 ng/mL, Gleason grade 4 or 5 is present, bone pain is present, or locally advanced tumor (T3Nx or T1-4N1-3) is identified 1

Negative Biopsy Result with Persistent Suspicion

• If suspicion is low: annual digital rectal examination and PSA determination 1
• If suspicion is high: determination of free PSA and/or PSA velocity, prostate MRI, repeat ultrasound-guided biopsies including the transition zone, and/or transurethral resection 1
• If curative treatment is not considered (life expectancy <10 years): no repeat biopsy is necessary 1

High-Grade PIN or Suspicious Lesions

• Only high-grade PINs should be noted on the histopathological report 1
• A further series of biopsies should be performed within 3 months 1
• When curative treatment is not planned (life expectancy <10 years), further biopsies are not recommended 1

Imaging in Initial Evaluation

• There is no indication for imaging in the primary diagnostic work-up as standard practice 1
• MRI and color Doppler ultrasound are under evaluation for the detection of cancer following negative initial biopsies 1
• Multiparametric MRI may be useful in patients with persistent PSA elevation and previous negative biopsies 3

Special Considerations

• For patients with T1a disease over 65 years old: re-evaluation after 2 months by digital rectal examination, PSA determination, and systematic transrectal ultrasound-guided biopsies 1
• For patients with T1a disease 65 years or younger, or T1b disease regardless of age: re-evaluation after 2 months by digital rectal examination, PSA determination, and systematic transrectal ultrasound-guided biopsies 1
• Curative treatment is not recommended for patients with a life expectancy of less than 10 years 1

Common Pitfalls and Caveats

• Transurethral resection is not recommended as a first-line biopsy if prostate cancer is suspected 1
• PSA can be elevated in non-malignant conditions such as prostatitis and benign prostatic hyperplasia, leading to false positives 4
• A single negative biopsy does not definitively rule out prostate cancer, especially with persistent clinical suspicion 1
• The diagnostic accuracy of DRE alone is limited (approximately 63.45%), highlighting the need for comprehensive evaluation 2