PSA and MRI Prostate Cancer Screening | NEJM

NEJM Group

26 Sept 202402:26

Summary

TLDRA study involving 13,153 men aged 50-60 suggests that performing prostate biopsies only in those with elevated PSA levels and MRI-visible lesions could reduce overdiagnosis of clinically insignificant prostate cancer. This approach lowered the risk of detecting such cancers by 57% without missing significant cancers, according to a trial published on NEJM.org.

Takeaways

🔍 **Overdiagnosis Issue**: Many prostate cancer diagnoses based on elevated PSA levels may be clinically insignificant and not life-threatening.
💉 **PSA and MRI Criteria**: The study focuses on men with elevated PSA levels and visible lesions on MRI for prostate biopsies.
👨‍🔬 **Trial Design**: A randomized, prospective, population-based trial involving 13,153 men aged 50 to 60.
📊 **PSA Threshold**: Men with a PSA level of 3 ng/mL or higher underwent prostate MRI.
🧬 **Biopsy Methods**: Participants were divided into groups for systematic biopsy with MRI-targeted biopsy or MRI-targeted biopsy alone.
🔄 **Screening Frequency**: Repeat screenings were scheduled every 2, 4, or 8 years based on PSA levels.
📉 **Risk Reduction**: The MRI-targeted biopsy group had a 57% lower risk of detecting clinically insignificant cancer compared to the systematic biopsy group.
🏥 **Clinically Significant Cancer**: The diagnosis rate of clinically significant cancer was similar in both groups.
🚑 **Adverse Events**: Five severe adverse events leading to hospitalization occurred, likely related to biopsy procedures.
📝 **Conclusion**: Omitting systematic prostate biopsy in men with elevated PSA and negative MRI results reduces overdiagnosis without missing significant cancers.

Q & A

What is the issue with diagnosing prostate cancer based on elevated PSA levels alone?
-Diagnosing prostate cancer based solely on elevated PSA levels can lead to overdiagnosis, where patients are diagnosed with clinically insignificant disease that will never progress to become a threat to their lives.
What is the potential harm of treating clinically insignificant prostate cancer?
-Treating patients with clinically insignificant prostate cancer can result in substantial life-altering side effects without the prospect of extending their lives.
What was the aim of the new study mentioned in the script?
-The aim of the study was to determine whether performing prostate biopsies only in men with elevated PSA levels and visible lesions on MRI could reduce overdiagnosis without missing clinically important prostate cancers.
How many participants were involved in the study?
-The study involved 13,153 men aged 50 to 60 years.
What were the two groups in the study?
-The participants were divided into two groups: one that underwent systematic biopsy and targeted biopsy if suspicious lesions were found on MRI, and another that only underwent MRI-targeted biopsy.
What were the intervals for repeat screenings in the study?
-Repeat screenings occurred every 2, 4, or 8 years, depending on the participants' PSA levels.
What was the median follow-up period for the study?
-The median follow-up period was 3.9 years.
What was the outcome for the MRI-targeted biopsy group regarding the risk of clinically insignificant cancer detection?
-The MRI-targeted biopsy group had a 57% lower risk of clinically insignificant cancer being detected at screening or as interval cancer compared to the systematic biopsy group.
Was there a difference in the diagnosis of clinically significant cancer between the two groups?
-The percentage of men diagnosed with clinically significant cancer was similar in both groups.
What was the incidence of severe adverse events related to biopsy in the study?
-Five severe adverse events leading to hospitalization occurred, with four likely related to biopsy.
What is the conclusion of the study regarding systematic prostate biopsy for men with elevated PSA levels and negative MRI results?
-The study concluded that omitting systematic prostate biopsy for men with elevated PSA levels and negative MRI results reduced diagnoses of clinically insignificant prostate cancer, and the associated risk of having incurable cancer diagnosed at screening or as interval cancer was very low.

Outlines

00:00

🏥 Prostate Cancer Overdiagnosis and MRI-Targeted Biopsies

A new study investigates whether performing prostate biopsies only in men with elevated PSA levels and visible lesions on MRI could reduce the overdiagnosis of prostate cancer without missing clinically significant cases. The trial involved 13,153 men aged 50 to 60, who underwent PSA screening and, if their PSA level was 3 ng/ml or higher, an MRI of the prostate. Participants were divided into two groups: one that received both systematic and targeted biopsies if MRI showed suspicious lesions, and another that only received MRI-targeted biopsies. The study found that after a median follow-up of 3.9 years, the MRI-targeted biopsy group had a 57% lower risk of detecting clinically insignificant cancer compared to the systematic biopsy group. However, the diagnosis rate of clinically significant cancer was similar in both groups, and severe adverse events were rare. The study suggests that omitting systematic prostate biopsies for men with elevated PSA levels and negative MRI results could reduce overdiagnosis without increasing the risk of missing significant cancers.

Mindmap

Keywords

💡Prostate-specific antigen (PSA)

Prostate-specific antigen (PSA) is a protein produced by cells in the prostate gland. Elevated levels of PSA in the blood can indicate prostate cancer or other prostate conditions. In the video, PSA is a key marker used to determine whether men should undergo further screening or diagnostic procedures, such as MRI or biopsy, to detect prostate cancer.

💡Overdiagnosis

Overdiagnosis refers to the detection of a disease that will not cause symptoms or death during a patient's lifetime. In the context of the video, many men with elevated PSA levels are diagnosed with prostate cancer that is clinically insignificant, meaning it would not progress to harm their health. Overdiagnosis can lead to unnecessary treatments with significant side effects.

💡Clinically insignificant disease

Clinically insignificant disease refers to a form of prostate cancer that is unlikely to progress or pose a threat to the patient’s life. In the video, the main concern is that systematic biopsies may identify these cancers, leading to overtreatment. The study investigates whether MRI-targeted biopsies can reduce the detection of such cancers, while still identifying more dangerous forms.

💡Systematic biopsy

A systematic biopsy is a method of randomly sampling tissue from different areas of the prostate to check for cancer. The video highlights that this approach often leads to overdiagnosis of clinically insignificant prostate cancer. The study compares this method with MRI-targeted biopsy to assess whether the latter reduces unnecessary diagnoses.

💡MRI-targeted biopsy

MRI-targeted biopsy is a more focused approach where suspicious lesions identified through MRI are specifically targeted for biopsy. This method is contrasted with systematic biopsy in the video, and the study examines whether it can lower the risk of detecting clinically insignificant prostate cancer without missing significant cases.

💡Clinically significant cancer

Clinically significant cancer refers to a form of cancer that is likely to progress and pose a risk to the patient’s health if left untreated. The study in the video found that the detection rate of clinically significant cancers was similar in both systematic and MRI-targeted biopsy groups, indicating that the targeted approach could help reduce overdiagnosis without missing important cancers.

💡Advanced or high-risk cancers

Advanced or high-risk cancers are aggressive forms of cancer that are more likely to spread and be life-threatening. In the video, the study reports that such cancers were uncommon in both biopsy groups. This suggests that both methods are effective at identifying more dangerous cancers, further supporting the argument for MRI-targeted biopsies.

💡Randomized prospective trial

A randomized prospective trial is a study in which participants are randomly assigned to different groups to compare outcomes over time. The video describes such a trial involving men with elevated PSA levels who were assigned to either systematic biopsy or MRI-targeted biopsy groups. This type of study design provides strong evidence for comparing the effectiveness of different diagnostic strategies.

💡Severe adverse events

Severe adverse events refer to significant, potentially harmful side effects of a medical procedure. In the video, five severe adverse events leading to hospitalization occurred, four of which were likely due to biopsy. This highlights the risks associated with prostate biopsies and the potential benefit of reducing unnecessary procedures by using MRI-targeted biopsies.

💡Interval cancer

Interval cancer is a type of cancer that is diagnosed between regular screenings. The video mentions that the risk of interval cancer was low in men with elevated PSA levels and negative MRI results who did not undergo systematic biopsy. This suggests that MRI-targeted biopsies could reduce overdiagnosis without increasing the likelihood of missing clinically significant cancers that develop between screenings.

Highlights

Prostate cancer diagnosed by systematic biopsy based on elevated PSA levels often leads to overdiagnosis of clinically insignificant cases.

Overdiagnosis can result in unnecessary treatments with life-altering side effects, without a prospect of extending patients' lives.

The study explores whether performing prostate biopsies only in men with elevated PSA levels and visible MRI lesions could reduce overdiagnosis.

The trial was a randomized, prospective, population-based study including 13,153 men aged 50 to 60 years.

Men with PSA levels of 3 ng/mL or higher underwent an MRI of the prostate before biopsy decisions.

Participants were divided into two groups: one underwent systematic biopsy, while the other had only MRI-targeted biopsy.

Repeat screenings were scheduled every 2, 4, or 8 years, based on PSA levels.

After a median follow-up of 3.9 years, the MRI-targeted biopsy group had a 57% lower risk of detecting clinically insignificant cancer.

Both groups had similar rates of clinically significant cancer detection, showing that MRI-targeted biopsies didn’t miss important cancers.

Advanced or high-risk prostate cancers were uncommon in both groups.

Five severe adverse events leading to hospitalization were observed, four of which were likely related to the biopsy procedure.

The study concluded that omitting systematic biopsy in men with elevated PSA and negative MRI reduced the diagnosis of clinically insignificant cancer.

The risk of having incurable cancer detected at screening or as interval cancer was very low when systematic biopsy was omitted.

MRI-targeted biopsies appear to be a promising method to reduce overdiagnosis and unnecessary treatments in prostate cancer.

Full trial results and further details are available on the NEJM website.