One of the most respected U.S. urologists is Dr. E. David Crawford, Professor of Surgery, Urology, and Radiation Oncology, and head of the Section of Urologic Oncology at the University of Colorado Anschutz Medical Campus. He gave a presentation to the plenary session of the recent European Association of Urology meeting in Madrid, on the topic of the best decision markers for prostate biopsy and rebiopsy. His key points range from screening to diagnosis, and I offer those that gave me much food for thought.
- What is a biomarker? It’s a molecule found in tissue, blood, or other bodily fluids that is a sign of a normal or abnormal process. Progress has been made in developing tests that provide information on which men have PCa and cannot afford to go on an observational strategy like active surveillance.
- Who does the most PSA screening? 90% of PSA blood tests are ordered by family practice and internal medicine doctors, with only about 6% ordered by urologists.
- When should a PSA test trigger a referral to a urologist? Based on data from 350,000 patient records in the Henry Ford Health System, analysts determined that men with a PSA less than 1.5 ng/mL have a less than 1% risk of prostate cancer in the next 5 years, so just keep screening them with PSA. However, a PSA between 1.5-4 ng/mL means a 7.8% chance of prostate cancer within 5 years (10% for African American men). Such a PSA value should be taken as a men’s health warning, as higher values are a surrogate for larger prostate volumes; this could mean BPH, prostatitis, prostate cancer or other conditions. In these cases, refer them to a urologist for discussion and possible biomarker tests such as the Prostate Health Index (PHI), PCA3 urine test, or 4Kscore (4 kallikreins). If these tests do not show increased risk, put the patient back on screening. However, they reveal increased risk for PCa, do a TRUS biopsy because the tests have it increased the chances of a true positive biopsy. (Remember, he’s addressing urologists, and TRUS biopsy is their standard diagnostic tool. But eventually he brings in mpMRI-guided targeted biopsy, as you will see).
- If the TRUS biopsy is negative, what’s the next step? Use the ConfirmMDX test, or PCA3; if either shows increased risk, this is where 3T mpMRI comes in. If imaging detects a suspicious lesion that was missed by the TRUS biopsy, an image-guided targeted biopsy can be conducted.
- If the TRUS biopsy is positive for low-risk cancer, is it safe to offer observational therapy? Use the Prolaris or OncotypeDX genomic analysis for information on the potential for an aggressive cell line.
By now it should be evident that Dr. Crawford is charting a path toward better patient care and medical cost savings. He points out that routine blood tests for men with PSA <1.5 would save a billion dollars annually!
To sum up the “road map” that Dr. Crawford offered his urology colleagues, it goes like this: When a man turns 50, he should start routine PSA tests similar to other annual blood tests such as lipids and blood sugar. If it’s below 1.5, come back in 5 years. If it’s above 1.5, refer to urologist for discussion and further monitoring. If the urologist finds the man’s PSA and DRE are suspicious for PCA, do a test like PHI, PCA3, or 4Kscore. If the results indicate low risk, return to routine PSA screening. If a higher risk level is apparent, do a TRUS biopsy. If the biopsy is negative, do the ConfirmMDX test. If those results are negative, go back to screening. However, if ConfirmMDX returns an unfavorable result, do a 3T mpMRI. See a suspicious area? Do an MRI-guided targeted biopsy. If it is positive with a high proportion of Gleason 4, discuss treatment options. If it’s Gleason 3+3, conduct a genomics test such as Prolaris or OncotypeDX to ascertain the genetic risk level. If the cell line is insignificant, the patient can embark on active surveillance subject to monitoring with 3T mpMRI.
This system helps urologists filter patients who will benefit from treatment, without unwarranted biopsies. I share Dr. Crawford’s goals regarding patient outcomes and quality of life, and spending the least amount of healthcare dollars necessary to obtain these goals. I share his vision of eliminating needless TRUS biopsies, and hope for the day when MRI-guided targeted biopsies become the standard of care.