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Prostate Cancer Management

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1. Management of Female Malignant Ovarian Germ Cell Tumours

. In: American Society of Clinical Oncology 2013 Educational Book. Alexandria, VA: ASCO; 2013. p. e210–16. 11. Lee-Jones L. Ovary: germ cell tumours. Atlas Genet Cytogenet Oncol Haematol 2003;7:282–8. 12. Solheim O, Kærn J, Tropé CG, Rokkones E, Dahl AA, Nesland JM, et al. Malignant ovarian germ cell tumors: presentation, survival and second cancer in a population based Norwegian cohort (1953–2009). Gynecol Oncol 2013;131:330–5. 13. Royal College of Obstetricians and Gynaecologists. Manage - ment (...) , Rustin GJ, Newlands ES. Chemotherapy for ovarian germ cell tumours. Eur J Cancer 1996;32A:593–7. 36. Luis IV , Coleman R. Ovarian germ cell malignancy: a heterogeneous tumour requiring supra-regional management. Eur J Gynaecol Oncol 2011;32:387–92. 37. Alifrangis C, Agarwal R, Short D, Fisher RA, Sebire NJ, Harvey R, et al. EMA/CO for high-risk gestational trophoblastic neoplasia: good outcomes with induction Scientific Impact Paper No. 52 8 of 10 © Royal College of Obstetricians

2016 Royal College of Obstetricians and Gynaecologists

2. AIM Clinical Appropriateness Guidelines for Molecular Testing of Solid and Hematologic Tumors and Malignancies

or Thrombocytosis 17 Primary Myelofibrosis 18 Genetic Testing for Hematologic Malignancy 18 Minimal Residual Disease (MRD) Genetic Testing 18 Solid Tumor Testing 19 NTRK Fusion Testing 19 PIK3CA Testing 20 Breast Cancer 20 Lung Cancer 22 Cell-Free Tumor Testing 23 Cancer of Unknown Primary/Occult Neoplasm 23 Pancreatic Cancer 24 Prostate Cancer 25 Thyroid Cancer 26 Cancer Screening 26 Indeterminate Thyroid Nodules 26 Colorectal Cancer Screening 28 Professional Society Guidelines 29 PROPRIETARY Guidelines (...) . All Rights Reserved. 6 ? Hepatobiliary cancer ? Kidney cancer ? Malignant pleural mesothelioma ? Merkle cell carcinoma ? Multiple myeloma ? Neuroendocrine and adrenal tumors - including gastrointestinal and lung ? Non-epithelial ovarian cancers or borderline epithelial tumors (low malignant potential) ? Occult primary ? Pancreatic cancer ? Prostate cancer - post-diagnosis gene expression classifiers ? Skin cancer - basal and squamous cell ? Small cell lung cancer ? T-cell lymphoma: cutaneous

2020 AIM Specialty Health

3. Skene's Gland Adenocarcinoma: Borrowing from Prostate Cancer Experience for the Evaluation and Management of a Rare Malignancy. (Abstract)

Skene's Gland Adenocarcinoma: Borrowing from Prostate Cancer Experience for the Evaluation and Management of a Rare Malignancy. To determine if adenocarcinoma of the Skene's glands in women, which has a histological and immunohistochemical appearance similar to prostate cancer, can be evaluated and managed with the same tools we use for prostate cancer.Serum prostate specific antigen (PSA) kinetics, 3D multiparametric (MP) magnetic resonance imaging (MRI), fluciclovine F-18 positron emission (...) of Skene's gland adenocarcinoma, we can employ many of the tools at our disposal for the evaluation and management of prostate cancer to benefit the women found to have this malignancy.Copyright © 2020. Published by Elsevier Inc.

2020 Urology

4. AIM Clinical Appropriateness Guidelines for Molecular Testing of Solid and Hematologic Tumors and Malignancies

criteria below for: • Myeloproliferative neoplasms • Breast Cancer • Cell-Free Tumor Testing • Cancer of Unknown Primary/Occult NeoplasmProstate Cancer (confirmed, not screening) • Thyroid Cancer and Indeterminate Thyroid Nodules • Colorectal Cancer Screening Polycythemia Vera JAK2 mutation testing is medically necessary for the diagnosis of polycythemia vera when both of the following conditions are met: • Genetic testing impacts medical management • ONE of the following criteria are met (...) as outlined in the criteria in the NCCN ® Clinical Practice Guidelines in Oncology (NCCN Guidelines ® ), Prostate Cancer Early Detection. Confirmed Malignancy Gene expression or molecular profiling assays for confirmed prostate tumors are not medically necessary. Thyroid Cancer Confirmed or Highly-Suspected Thyroid Cancer BRAF V600E mutation analysis is medically necessary in cases with confirmed or highly-suspected follicular thyroid carcinoma, papillary thyroid carcinoma, medullary thyroid carcinoma

2019 AIM Specialty Health

5. Nine primary malignant neoplasms-involving the esophagus, stomach, colon, rectum, prostate, and external ear canal-without microsatellite instability: a case report. (Full text)

is extremely rare, the present case of nine primary malignancies with no associated microsatellite instability and no apparent predisposing hereditary conditions, is extraordinary. Our case study shows that it is possible for up to nine sporadic neoplasms to occur, and efficient disease management requires diligent screening and early detection. (...) Nine primary malignant neoplasms-involving the esophagus, stomach, colon, rectum, prostate, and external ear canal-without microsatellite instability: a case report. Although cases of multiple primary malignant neoplasms are increasing, reports of more than three or four primary metachronous malignant neoplasms are extremely rare. Moreover, very few publications have provided a genetic mutational analysis or have evaluated risk factors associated with such neoplasms. We present an extremely

2018 BMC Cancer PubMed abstract

6. AIM Clinical Appropriateness Guidelines for Molecular Testing of Solid and Hematologic Tumors and Malignancies

Tumor Testing 10 Breast Cancer 10 Lung Cancer 12 Cell-Free Tumor Testing 13 Cancer of Unknown Primary/Occult Neoplasm 14 Prostate Cancer 14 Thyroid Cancer 15 Cancer Screening 15 Indeterminate Thyroid Nodules 15 Colorectal Cancer Screening 16 Professional Society Guidelines 18 Selected References 19 Revision History 20 PROPRIETARY Guidelines developed by, and used with permission from, Informed Medical Decisions, Inc. © 2017 Informed Medical Decisions, Inc. All Rights Reserved. 3 Scope This document (...) addresses molecular testing and gene expression profiling of solid and hematologic tumors and malignancies for the purpose of diagnosis, selecting chemotherapeutic agents and predicting risk, prognosis or recurrence of cancer. Appropriate Use Criteria Somatic tumor testing is medically necessary when all of the following criteria are met: • Identification of the specific genetic variant or profile has been demonstrated to improve diagnosis, management, or clinical outcomes for the individual’s tumor

2017 AIM Specialty Health

7. Padeliporfin (Tookad) - prostate cancer / Prostatic Neoplasms

the Committee, issued a positive opinion for granting a marketing authorisation to Tookad on 14 September 2017. 2. Scientific discussion 2.1. Problem statement 2.1.1. Disease or condition Tookad is indicated as monotherapy for adult patients with previously untreated, unilateral, low-risk, adenocarcinoma of the prostate with a life expectancy = 10 years and: - Clinical stage T1c or T2a, - Gleason Score = 6, based on high-resolution biopsy strategies, - PSA = 10 ng/mL, - 3 positive cancer cores (...) Padeliporfin (Tookad) - prostate cancer / Prostatic Neoplasms 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/contact 14 September 2017 EMA/644309/2017 Committee for Medicinal Products for Human Use (CHMP) Assessment report TOOKAD International non-proprietary name: padeliporfin Procedure No. EMEA/H/C/004182/0000 Note Assessment report

2017 European Medicines Agency - EPARs

8. Primary malignant peripheral nerve sheath tumor of prostate in a young adult: A case report. (Full text)

Primary malignant peripheral nerve sheath tumor of prostate in a young adult: A case report. Prostate sarcoma has been reported to represent 0.7% of primary prostate malignancies. Leiomyosarcoma and rhabdomyosarcoma are the most common sarcomas of the prostate. Malignant peripheral nerve sheath tumor (MPNST) of the prostate is very rare.A 22-year-old man presented with gross hematuria and voiding difficulty for 2 weeks. Magnetic resonance imaging showed a 6-cm mass in the left lobe (...) . However, chest CT showed multiple lung metastases a month after prostatectomy. A chemotherapeutic regimen of doxorubicin and ifosfamide was administered.The best response to chemotherapy was partial response. After several courses of chemotherapy, he died 9 months after the surgery.Primary prostate sarcoma and even MPNST are extremely rare. MPNST of the prostate has seldom been reported. This report may help diagnose and manage the disease.

2018 Medicine PubMed abstract

9. Comprehensive molecular classification of localized prostate adenocarcinoma reveals a tumour subtype predictive of a non-aggressive disease. (Full text)

Comprehensive molecular classification of localized prostate adenocarcinoma reveals a tumour subtype predictive of a non-aggressive disease. Management of localized prostate cancer (PCa) is a major clinical challenge since most of these cancers would not evolve but a majority of patients will still undergo a life-changing radical surgery. Molecular studies have shown that PCa can be classified according to their genomic alterations but none of the published PCa molecular classifications could (...) identify a subtype corresponding to non-evolutive tumours.Multi-omics molecular profiling was carried out on post-radical prostatectomy material from a cohort of 130 patients with localized PCa. We used unsupervised classification techniques to build a comprehensive classification of prostate tumours based on three molecular levels: DNA copy number, DNA methylation, and mRNA expression. Merged data from our cohort and The Cancer Genome Atlas cohort were used to characterize the resulting tumour

2018 Annals of Oncology PubMed abstract

10. Effective Project Management of a Pan-African Cancer Research Network: Men of African Descent and Carcinoma of the Prostate (MADCaP) (Full text)

Effective Project Management of a Pan-African Cancer Research Network: Men of African Descent and Carcinoma of the Prostate (MADCaP) Health research in low- and middle-income countries can generate novel scientific knowledge and improve clinical care, fostering population health improvements to prevent premature death. Project management is a critical part of the success of this research, applying knowledge, skills, tools, and techniques to accomplish required goals. Here, we describe (...) the development and implementation of tools to support a multifaceted study of prostate cancer in Africa, focusing on building strategic and operational capacity.Applying a learning organizational framework, we developed and implemented a project management toolkit (PMT) that includes a management process flowchart, a cyclical center-specific schedule of activities, periodic reporting and communication, and center-specific monitoring and evaluation metrics.The PMT was successfully deployed during year one

2018 Journal of global oncology PubMed abstract

11. Prostate cancer: diagnosis and management

Prostate cancer: diagnosis and management Prostate cancer: diagnosis and Prostate cancer: diagnosis and management management NICE guideline Published: 9 May 2019 www.nice.org.uk/guidance/ng131 © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Y Y our responsibility our responsibility The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When (...) . Ov Overview erview This guideline covers the diagnosis and management of prostate cancer in secondary care, including information on the best way to diagnose and identify different stages of the disease, and how to manage adverse effects of treatment. It also includes recommendations on follow-up in primary care for people diagnosed with prostate cancer. Who is it for? Healthcare professionals Commissioners and providers of prostate cancer services People with prostate cancer, their families

2019 National Institute for Health and Clinical Excellence - Clinical Guidelines

12. A Window of Opportunity Study to Investigate Mechanisms of Actions of Novel Therapeutic Agents in Patients With Resectable Solid Tumor Malignancies

for elective surgical resection, disease does not require immediate therapy, and there is NO approved/ standard therapy available that is shown to prolong overall survival. ECOG performance status of 0 or 1. Must have a tumor lesion that is amenable to biopsy, and willing to undergo biopsy. Willing to provide tissue and blood samples for research. Exclusion Criteria: The following solid tumors are NOT eligible: Primary brain tumor, Ocular melanoma, Head and neck cancer, Breast cancer, Prostate cancer (...) A Window of Opportunity Study to Investigate Mechanisms of Actions of Novel Therapeutic Agents in Patients With Resectable Solid Tumor Malignancies A Window of Opportunity Study to Investigate Mechanisms of Actions of Novel Therapeutic Agents in Patients With Resectable Solid Tumor Malignancies - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies

2018 Clinical Trials

13. Outcomes of secondary solid tumor malignancies among patients with myeloma: A population-based study. (Full text)

Outcomes of secondary solid tumor malignancies among patients with myeloma: A population-based study. Therapeutic advances have extended survival for patients with myeloma, who may develop secondary cancers.Using the population-based Surveillance, Epidemiology, and End Results registry (2004-2015), the authors examined the characteristics, overall and cause-specific survival, and cumulative incidence function of cancer-related death among patients with myeloma with secondary cancers (...) of disease. There was no significant difference noted with regard to noncancer deaths for any studied solid tumor. Use of surgery (evaluated in patients with nonmetastatic tumors, and in addition matched by disease stage) did not differ between cases and controls, except for fewer prostatectomies being noted among patients with myeloma (odds ratio, 0.56; 95% confidence interval, 0.42-0.74).The results of the current study support curative treatment approaches to secondary cancers among patients

2018 Cancer PubMed abstract

14. Phase I Study of AZD5363 + Olaparib + Durvalumab (MEDI4736) in Patients With Advanced or Metastatic Solid Tumor Malignancies

Phase I Study of AZD5363 + Olaparib + Durvalumab (MEDI4736) in Patients With Advanced or Metastatic Solid Tumor Malignancies Phase I Study of AZD5363 + Olaparib + Durvalumab in Patients With Advanced or Metastatic Solid Tumor Malignancies - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum (...) with advanced or metastatic solid tumor malignancies. The purpose of this trial is to determine if combination treatment of drugs, Olaparib, AZD5363 and Durvalumab has beneficial effects in advanced or metastatic cancers and to determine the effects it has on patients and their cancer. Primary Objectives • To evaluate the safety and tolerability of combination treatment AZD5363 + Olaparib + Durvalumab and determine the Maximum Tolerated Dose (MTD), Dose-Limiting Toxicities (DLTs), and Recommended Phase 2

2018 Clinical Trials

15. PSMA-Targeting Positron Emission Agents for Imaging Solid Tumors Other Than Non-Prostate Carcinoma: A Systematic Review. (Full text)

PSMA-Targeting Positron Emission Agents for Imaging Solid Tumors Other Than Non-Prostate Carcinoma: A Systematic Review. Despite its name, prostate-specific membrane antigen (PSMA) has been shown using immunohistochemistry (IHC) to also be over-expressed in the tumor neovasculature of a wide variety of solid tumors other than prostate carcinoma. Accordingly, positron-emitting radiolabeled small molecules targeting PSMA, initially developed for positron emission tomography in prostate carcinomas (...) , are currently being explored for their staging and restaging potential as an alternative imaging modality in other solid tumor types where 18-F-fluorodeoxyglucose (FDG)-PET imaging has low diagnostic accuracy. In this paper, the currently available literature in this field is reviewed. Preliminary, mainly retrospective studies are encouraging, with evidence of improved diagnostic sensitivity and specificity in clear cell renal carcinoma, glioma, and hepatocellular carcinoma, leading to a change in patient

2020 International journal of molecular sciences PubMed abstract

16. Neratinib (Nerlynx) - Breast cancer, breast neoplasms

disease-free survival DFS-DCIS disease-free survival including ductal carcinoma in situ ECG electrocardiogram ECOG Eastern Cooperative Oncology Group EGFR epidermal growth factor receptor EQ-5D EuroQol 5-Dimension Questionnaire ER estrogen receptor ERBB erythroblastic leukemia viral oncogene homolog; also termed HER ExteNET Extended Adjuvant Treatment of Breast Cancer with Neratinib FACT-B Functional Assessment of Cancer Therapy-Breast FMO flavin-containing monooxygenase GI gastrointestinal HER human (...) Neratinib (Nerlynx) - Breast cancer, breast neoplasms 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged. 13 July 2018 EMA/CHMP/525204/2018 Committee for Medicinal Products for Human Use (CHMP) Assessment report Nerlynx International

2018 European Medicines Agency - EPARs

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