Prague, Czech Republic (UroToday.com) Dr. Michiel Sedelaar will present his selections "Best Prostate Cancer" at this session. He notes that more than 10,000 manuscripts last year and many of them may have an impact on clinical management. Still, he decided to highlight 4, which are likely to be "game changers" and require more attention. They cover two specific areas: the diagnosis of prostate cancer and the treatment of metastatic prostate cancer.
- PRECISION study by Kasivisvanathan et al.1
In this study, the authors randomized 500 men with a clinical suspicion of PCA for MRI (biopsy or non-biopsy, depending on the results) (TBx) on standard biopsies (SBx) with controlled TRUS 10-12.
- 28% of MRI did not have any abnormalities in MRI, so they did not receive a biopsy (which was a study critique)
- The clinically significant group of PCa – MRI identified 38%, while the SBx group identified 26%
- The clinically insignificant PCa-MRI group identified 13% less than the SBx group (9 vs. 22%)
- He noted that patients with target PIRADS 3 lesions had a very low yield – 67% were negative, only 12% were csPCa
- Based on these authors, it should be noted that 28% of patients could prevent biopsy – and those who received one receive only 4 nuclei, less pain, fewer risks
However, it should be noted that NPV for csPCa MRI is only 76% – so about 1/4 may have a type 4 disease.
His study summary is here:
- Study 4M van der Leest et al.2 – note, Dr. Sedelaar is one of the co-authors of this study.
In this study, 699 men MPMRI, TRUS Bx (12 nuclei) and targeted biopsy for each lesion PIRADS 3-5 were tested in four centers in 2 centers in four centers.
- MPMRI detected 25% csPCA and 14% ciPCa
- TRUS Bx itself detected 23% csPCa but 25% ciPCa
- MRI would avoid 49% of biopsies in patients and reduce the number of biopsies by 89%
- In 49% of patients who would avoid biopsy, it was found that at 1 year only 4% had csPCa
- The complete patient diagram is shown below:
He notes that, unlike the first study, only 6% MPMRI had PIRADS 3 lesions – so their experienced radiologists were better and confidently called lesions either PIRADS 1-2 or 4-5.
Based on these results, the authors conclude that the starting mpMRI yields a higher yield of csPCa and a lower yield of ciPCa. The radiologist's experience is the key to success.
When we joined them, his message of acceptance was:
MPMRI should be considered pre-treatment in patients, but is usually performed in experienced centers and in patients at high risk of PCA. Otherwise it would not be costly or time-consuming.
Therapy in metastatic PCa: The role of radiotherapy
- The HORRAD process by Boeva et al.3
In this very significant multicenter RCT completed in 2004-2014, 432 mPCa patients were randomized either to ADT (standard care at the time) or to radiation of ADT + to the primary tumor. Radiotherapy was 70 Gy in 30 fractions or 59 gray in 19 fractions.
- In both groups there was no difference (43 months vs. 45 months)
- There was no time difference to PSA progression in both groups (12 months vs. 15 months)
- However, it should be noted that this patient population had a very high volume metastatic load – Most of them were Gleason 8-9,> 50% had 5 + bone mets, and 60% were cT3
- In subgroup analysis, there is evidence that men with <5 bone metamics may have some benefit (HR 0.68, CI 0.42-1.1).
Finally, although there were several limitations, this negative study provided some important data. Probably, these patients were too advanced to get any benefit. But in a subgroup with a lower volume of metastatic disease, <ct2 disease and good performance, there may be some OS gain.
- Shoulder arm of STAMPEDE by Parker et al.4
Shortly thereafter, the investigators of STAMPEDE released this arm of a multi-arm study, comparing men with mPCa with the standard of care (ADT +/- docetaxel) on SOC + radiotherapy (55Gy in 20 fx or 36Gy in 6 fractions). While a slightly lower dose than HORRAD, this study is beneficial for the planned subgroup analysis based on CHAARTED metastatic load criteria of low and high volume.
- In non-selected patients (all-comers) radiotherapy did not improve the OS
- However, in selected patients with low volume of metastatic load (<4 bone metastases and all in bony pelvis), OS benefit. It seemed beneficial to all of the endpoints.
By putting these two studies together, there is an explanation:
Submitted by: Michiel Sedelaar, Onco Urologist, Deputy Chief of the Department, Nijmegen Region, Netherlands, Hospital and Health Care
Written by: MUDr. Thenappan Chandrasekar. Clinical instructor, Thomas Jefferson University, Twitter: @tchandra_uromd, @TjuUrology, at the 16th session of the European Section of Oncological Urology, # ESOU19, 18-20. January 2019, Prague, Czech Republic
1. Kasivisvanathan V, et al. PRECISION Study Group Collaborators. MRI-targeted or standard biopsies for the diagnosis of prostate cancer. N Engl J Med. 2018, May 10; 378 (19): 1767-1777. two: 10.1056 / NEJMoa1801993. Epub 2018 on March 18.
Van der Leest M, et al. Comparison of the diagnosis of transrectal ultrasound biopsy of the prostate with multiparametric imaging resonance of the prostate followed by magnetic resonance biopsy in biopsies of untreated men with elevated prostate antigen: a large prospective multicenter clinical study. Eur Urol. 2018. 23. pii: S0302-2838 (18) 30880-7. two: 10.1016 / j.urur.2018.11.023. [Epub ahead of print]3. Boevé LMS, et al. Effect on the survival of androgen depression alone compared to androgen depression in combination with concurrent prostate radiation therapy in patients with primary bone metastatic prostate cancer in a prospective randomized clinical trial: Data from the HORRAD study. Eur Urol. 2018 September 25 pii: S0302-2838 (18) 30658-4. two: 10.1016 / j.urur.2018.09.008. [Epub ahead of print]4. Parker CC et al. Systemic therapy of advanced or metastatic prostate cancer: Investigation of drug efficacy investigators (STAMPEDE). Primary tumor radiotherapy for newly diagnosed, metastatic prostate cancer (STAMPEDE): a randomized controlled phase 3 study of the lancet. 2018 December 1; 392 (10162): 2353-2366. doi: 10.1016 / S0140-6736 (18) 32486-3. Epub 2018 on October 21.
Other related content:
Best of Uro-Oncology 2018: Penis and Testicular Cancer
Best of uro-oncology 2018: Renal cancer
The Best of Uro-Oncology 2018 – Urothelial Cancer