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Even this bleak outlook is subject to great uncertainty and significant downside risks. The forecast assumes that the pandemic recedes in such a way that domestic mitigation measures can be lifted by mid-year in advanced economies and later in developing countries, that adverse global spillovers ease during the second half of 2020, and that widespread financial crises are avoided. This scenario would envision global growth reviving, albeit modestly, to 4.2% in 2021.
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2. Clinicians should discuss treatment options with advanced prostate cancer patients based on life expectancy, comorbidities, preferences, and tumor characteristics. Patient care should incorporate a multidisciplinary approach when available. (Clinical Principle)
Since the initial publication of this guideline, the FDA has approved two new PET agents for the management of advanced prostate cancer,68 Ga-PSMA-11 and 18F-DCFPyl.52,53 PSMA is a transmembrane protein highly overexpressed in over 90% of prostate cancers. 68Ga-PSMA-11 is a radiolabeled small molecule that binds to the PSMA receptor. It has high specificity and sensitivity and outperforms standard CT and MRI in detection of nodal and osseous metastases.54,55 In a recent prospective study of men who had undergone prostatectomy and had a rising PSA still under 2.0ng/mL, PSMA-PET detected occult metastases significantly more frequently than fluciclovine-PET with an odds ratio over 4.56 18F-DCFPyl, another small molecule that binds to the extracellular domain of PSMA with high affinity, was shown to have a correct localization rate of 84.8% -87.0% in a study of 208 men with rising PSA following curative intent surgery or radiotherapy.57 Both 68Ga-PSMA-11 and 18F-DCFPyl are indicated for patients with suspected prostate cancer metastasis considering surgery or radiation therapy and also indicated for patients with suspected prostate cancer recurrence based on elevated serum PSA levels. The role of PSMA-PET in assessing indications and response for metastatic patients is still under investigation. Additional PSMA agents are currently under investigation. PET agents such as 11C-choline have FDA approval but are no longer in routine use for prostate cancer due to lower sensitivity and specificity for metastatic disease compared to other agents.51 Further, the short half-life of 11C-choline requires that it be manufactured on site, so it is impractical for most centers.
At the time of initial publication of this guideline, the methods for achieving castrate levels of testosterone were either surgical or injectable. On December 18, 2020, the FDA approved relugolix as the first oral GnRH receptor antagonist for adult patients with advanced prostate cancer.82 Approval was based on the phase 3 HERO study that showed favorable testosterone suppression and adverse effects of oral relugolix (120 mg/day) compared to leuprolide.83
In a case series of 1,033 patients with advanced prostate cancer 3.1% had a microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) prostate cancer, with more than half of those treated with anti PD-1 therapy responding to treatment having a >50% decline in PSA.132
It is now more clear than ever that multimodality approaches and integration of care are critical to improving the care for men with prostate cancer. Multidisciplinary clinics and the resulting multimodality treatment approaches can optimize treatment selection, maximize results and minimize overtreatment and side effects.151 Many clinical trials are evaluating the concepts of integrating systemic therapy with radiation and/or surgery, such as optimizing treatment of men with locally advanced primary tumors, assessing the benefit of local therapy in men with metastatic disease, or determine the impact of metastasis-directed therapy in the oligometastatic setting. The results of these studies are likely to substantially impact the standard approaches to newly diagnosed patients with advanced disease.