Does a Negative Prostate Biopsy Reduce the Risk of Prostate Cancer Reclassification in an Active Surveillance Protocol? An Updated Systematic Review and Meta‐Analysis - Bahri - The Prostate - Wiley Online Library
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| Negative Biopsy provides info in AS |
Negative Biopsy Results Offer Hope for Prostate Cancer Patients on Active Surveillance
New research shows that negative confirmatory and follow-up biopsies significantly reduce the risk of prostate cancer reclassification, offering better long-term outcomes for patients.
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In the evolving landscape of prostate cancer treatment, active surveillance (AS) is emerging as a key strategy for managing low-risk cases. A recent systematic review and meta-analysis published in January 2025 reveals promising findings for patients undergoing active surveillance: negative biopsy results—both confirmatory and follow-up—are strongly associated with a reduced risk of cancer reclassification and upgrading.
Active surveillance has become a go-to option for men diagnosed with low-risk or favorable intermediate-risk prostate cancer. Instead of immediately opting for more aggressive treatments like surgery or radiation, patients are closely monitored through regular tests, including PSA levels, digital rectal exams (DRE), and periodic biopsies. If the cancer shows signs of progression, the treatment approach may be adjusted. However, the timing of this intervention is critical to avoid overtreatment.
The new study analyzed data from over 17,000 patients across 13 studies conducted between 2008 and 2023. It showed that for men on active surveillance, a negative biopsy can be a strong indicator of long-term stability. Specifically, the study found that after a negative confirmatory biopsy, the risk of reclassification—meaning a shift to a more aggressive form of cancer—was reduced by 54%. Furthermore, the risk of upgrading, or the cancer's progression to a higher grade, was also significantly lower, decreasing by 43%.
These findings are supported by negative follow-up biopsies, which demonstrated a similar reduction in reclassification and upgrading. The meta-analysis reported a 55% reduction in the risk of reclassification and a 43% decrease in the chance of cancer upgrading for patients with negative follow-up biopsies compared to those with positive results.
For patients and their healthcare providers, these findings are significant. Dr. Razman Arabzadeh Bahri, lead author of the study, explains, “A negative biopsy offers valuable reassurance that the cancer remains indolent. This means patients can safely continue with active surveillance without needing immediate intervention, which can come with unwanted side effects.”
In clinical practice, the study encourages doctors to consider extending the follow-up intervals for patients with negative biopsy results. By doing so, patients can potentially avoid unnecessary treatments and invasive procedures, all while maintaining careful monitoring.
Importantly, these findings are not without caution. While negative biopsies are promising, the study also highlights the limitations of biopsies. Prostate cancer can sometimes be focal, meaning that certain areas may be missed during sampling. As such, it is crucial to combine biopsies with other monitoring tools, such as MRI, to get a clearer picture of cancer activity.
Still, the study provides a hopeful outlook for prostate cancer patients who choose active surveillance. With negative biopsies, patients can have greater confidence in their management plan, knowing that their cancer is less likely to progress in the short term.
For men with low-risk prostate cancer, the path forward may be clearer than ever—thanks to the latest research reinforcing the role of negative biopsies in predicting favorable outcomes under active surveillance.
Sources:
Arabzadeh Bahri, R., Mohammadi, A., Zemanati Yar, E., et al. "Does a Negative Prostate Biopsy Reduce the Risk of Prostate Cancer Reclassification in an Active Surveillance Protocol? An Updated Systematic Review and Meta-Analysis." Published in Prostate, January 2025.
ABSTRACT
Objectives
To evaluate the association of the negative confirmatory and follow-up biopsy with prostate cancer reclassification in active surveillance protocol.
Materials and Methods
A systematic search was performed in databases, including Scopus, PubMed, Embase, and Web of Science, on June 25th, 2024, to identify relevant studies regarding negative biopsy and reclassification of prostate cancer among men on AS. The patient data including, sample sizes, follow-up duration, the status of performing the confirmatory biopsy, hazard ratio (HR), and 95% confidence intervals (CI) of each reported HR were evaluated in each study. The relationships between negative biopsies and reclassification were assessed using a forest plot. A random-effect meta-analysis was used when high heterogeneity existed among the studies. Otherwise, a fixed-effect meta-analysis was utilized. A p value of less than 0.05 was considered statistically significant. All statistical analyses were performed by using STATA statistical software, version 16.
Results
A total of 13 articles were included in the study. These articles were published between 2008 and 2023, with the majority being published in recent years (2020–2023). The included articles evaluated a total of 17,900 patients. Our results regarding reclassification and upgrading are represented according to the confirmatory biopsy and subsequent follow-up biopsies. After a negative confirmatory biopsy, the pooled HR for reclassification was 0.46 (95% CI: 0.38–0.55, p < 0.01). Secondly, the study demonstrated that a decreased chance of cancer upgrading was also connected with negative confirmatory biopsies with a pooled HR of 0.57 (95% CI: 0.45–0.72, p < 0.01). Negative follow-up biopsies were linked to a 55% decrease in the risk of reclassification, according to the pooled HR for reclassification in patients with negative biopsies compared to those with positive biopsies of 0.45 (95% CI: 0.42–0.48, p < 0.01). Also, patients with negative follow-up biopsies had a pooled HR for upgrading of 0.57 (95% CI: 0.48–0.67, p < 0.01), indicating a 43% lower chance of upgrading than in patients with positive biopsies.
Conclusion
In active surveillance of PCa patients, a negative confirmatory biopsy decreased the chance of cancer reclassification and upgrading, with the pooled OR 0.46 and 0.57 [p < 0.01], respectively. Also, negative follow-up biopsies were linked to a decreased chance of cancer reclassification and upgrading. Our review recommends extend the follow-up evaluations in PCa patients with negative findings in surveillance biopsy who scheduled for active surveillance.
What Does a Negative Biopsy Show
A negative prostate biopsy is generally associated with a reduced risk of prostate cancer reclassification in active surveillance (AS) protocols. Here’s an overview of the relationship:
Background on Active Surveillance
Active surveillance is a management strategy for men with low-risk or favorable intermediate-risk prostate cancer. It involves close monitoring with periodic prostate-specific antigen (PSA) testing, digital rectal exams (DRE), imaging (like MRI), and repeat biopsies to detect any progression or reclassification of the disease.
Role of a Negative Prostate Biopsy
A negative prostate biopsy means that no cancerous cells were found in the sampled tissue. Studies have shown the following associations:
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Reduced Risk of Reclassification:
- Men with a negative biopsy during active surveillance often have a lower likelihood of upgrading or upstaging of their prostate cancer in subsequent assessments.
- This may reflect either true absence of cancer progression or sampling error due to the heterogeneity of prostate cancer.
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Improved Risk Stratification:
- A negative biopsy provides additional reassurance about the indolent nature of the disease, supporting continued AS rather than more aggressive treatment.
- Imaging techniques like multiparametric MRI can help guide biopsy and increase confidence in the negative result.
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Psychological and Clinical Benefits:
- A negative biopsy can reduce anxiety and reinforce the decision to stay on AS.
- It may also lead to longer intervals between subsequent monitoring biopsies, depending on the AS protocol.
Caveats
- Sampling Error: A negative biopsy does not completely rule out cancer progression, as prostate cancer can be focal or missed during biopsy.
- Imaging-Guided Biopsy: Incorporating MRI-targeted biopsies can enhance the accuracy of detecting clinically significant cancer, reducing the likelihood of false negatives.
Supporting Evidence
Numerous studies, including data from large AS cohorts such as the Johns Hopkins Active Surveillance Program and others, have shown that negative biopsies correlate with lower rates of cancer progression and a longer duration of AS. However, individual risk factors (e.g., PSA density, family history, genomic markers) should also be considered.
In conclusion, a negative prostate biopsy in an AS protocol is a favorable prognostic indicator, but it must be interpreted in the context of the overall clinical picture and monitoring protocol.
What Does This Study Show
This systematic review and meta-analysis highlights the importance of negative confirmatory and follow-up biopsies in prostate cancer (PCa) active surveillance (AS) protocols. Here’s a summary of the key findings:
Key Findings
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Negative Confirmatory Biopsy:
- A negative confirmatory biopsy significantly reduces the risk of cancer reclassification in patients under active surveillance. Specifically, the pooled hazard ratio (HR) for reclassification after a negative confirmatory biopsy was 0.46 (95% CI: 0.38–0.55, p < 0.01). This indicates a 54% decrease in the risk of reclassification compared to those with positive biopsies.
- The likelihood of cancer upgrading (i.e., an increase in cancer grade) was also lower after a negative confirmatory biopsy, with a pooled HR of 0.57 (95% CI: 0.45–0.72, p < 0.01), which suggests a 43% reduction in the chance of upgrading.
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Negative Follow-Up Biopsy:
- Negative follow-up biopsies were associated with a 55% decrease in the risk of reclassification, as the pooled HR for reclassification was 0.45 (95% CI: 0.42–0.48, p < 0.01).
- Similarly, patients with negative follow-up biopsies had a 43% lower chance of upgrading, with a pooled HR of 0.57 (95% CI: 0.48–0.67, p < 0.01).
Implications for Active Surveillance
The study reinforces the clinical utility of negative biopsies in predicting favorable outcomes in prostate cancer management under active surveillance. Specifically:
- Negative biopsies—both confirmatory and follow-up—are linked to a significantly reduced risk of reclassification or upgrading of prostate cancer.
- These findings suggest that patients with negative biopsy results may have a prolonged period before needing more aggressive treatments, potentially extending the follow-up intervals or reducing the frequency of monitoring biopsies in some cases.
Conclusion
The evidence supports the use of negative biopsies (both confirmatory and follow-up) as a reassuring factor in active surveillance protocols for prostate cancer. Patients with negative biopsy results should be considered at a lower risk for progression, and extended follow-up evaluations can be considered as part of their management. This approach can help reduce the need for unnecessary interventions and improve the quality of life for patients.
This updated meta-analysis provides strong evidence for the clinical benefits of negative biopsy findings in guiding treatment decisions for patients under active surveillance.
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