Prostate cancer is the one of the most diagnosed malignancies among men worldwide, posing a significant global health challenge. While it remains a major public health concern in the US, China has also experienced a steady increase in prostate cancer incidence rates in recent years. The traditional approach to diagnosing this disease has been through prostate biopsy. But with the remarkable progress in imaging technologies, the medical community is now exploring the possibility of skipping preoperative biopsy in prostate cancer cases, sparking a wave of discussion and research.

Prostate biopsy, usually carried out via the transrectal or transperineal approach, has been the routine diagnostic tool for prostate cancer.¹ However, this invasive procedure has some notable downsides. Transrectal ultrasound–guided biopsy has a false-negative rate as high as 30%. The reason is that it often fails to sample the anterior and apical parts of the prostate properly. Moreover, it can cause various problems such as infection, hematuria, and pain. These issues have encouraged doctors and researchers to look for better diagnostic alternatives.

The development of multiparameter MRI (mpMRI) and prostate-specific membrane antigen (PSMA) positron emission tomography (PET)/CT has brought a new dawn to prostate cancer diagnosis. The PRIMARY trial has demonstrated that combining PSMA PET/CT and mpMRI can significantly improve the ability to detect clinically significant prostate cancer.² This combination not only increases the negative predictive value but also boosts the sensitivity, suggesting that in certain situations, biopsy might be avoidable.

Clinicians and researchers are actively investigating the feasibility of performing radical prostatectomy without prior biopsy. Our team first explored this concept. Between June 2014 and December 2018, we collected 11 cases of laparoscopic radical prostatectomy without prostate biopsy.³ All patients received prostate MRI, and 6 also had positive 68Ga-PSMA PET/CT results. The surgeries were successful, and the final pathology confirmed prostate cancer in 10 cases, with 1 case being benign prostatic hyperplasia. We conducted a multicenter retrospective study involving 56 cases.⁴ These patients had maximum standardized uptake value of ≥ 4 and Prostate Imaging Reporting and Data System (PI-RADS) ≥ 4 lesions and underwent radical prostatectomy without biopsy. Pathology showed that 98% had prostate cancer, with 89% having clinically significant cases. These studies indicated that in the era of advanced imaging and minimally invasive techniques, the traditional practice of mandating prostate biopsy before radical prostatectomy might need to be reconsidered.

A study by Meissner et al⁵ reported a series of 25 patients with high suspicion of prostate cancer based on mpMRI (PI-RADS ≥ 4) and PSMA PET (PET score ≥ 4 and maximum standardized uptake value ≥ 4.0) who underwent radical prostatectomy without biopsy, and all were confirmed to have prostate cancer by postoperative pathology.

A recent single-center prospective study introduced an innovative noninvasive diagnostic approach.⁶ By using a model that combines the PI-RADS score and PSA density, along with 18F-PSMA-1007 PET/CT examination, the researchers achieved an impressive 98.2% positive predictive value for clinically significant prostate cancer in 57 patients. This result further supports the idea that skipping biopsy could be a viable option in some cases.

However, the concept of bypassing preoperative biopsy also raises some valid concerns. One of the main worries is misdiagnosis. Even though the combined use of mpMRI and PSMA PET/CT is quite accurate, there are still false-positive and false-negative results. For example, some patients might be incorrectly diagnosed with prostate cancer, which could lead to unnecessary surgeries. Another concern is that biopsy provides important information about the cancer, like the Gleason score and how the cancer is graded. This information is crucial for deciding the best treatment plan and predicting how the disease will progress. Without biopsy, doctors might lack these essential data.

Looking to the future, the idea of omitting preoperative biopsy in prostate cancer has great potential, but more research is needed. Large-scale, multicenter, and prospective studies are required to prove that this approach is safe and effective. The development of new diagnostic technologies, such as liquid biopsy and genetic testing, could further improve the accuracy of diagnosis and help doctors choose the right patients for biopsy-free radical prostatectomy.

In summary, while the idea of skipping preoperative biopsy in prostate cancer shows promise, it is not yet a standard practice in the medical field. With continuous research and technological advancements, it may become a common and accepted option in the future, offering better treatment choices and improved outcomes for men with prostate cancer.