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International guidelines recommend genetic testing to assist in patient selection for treatment with PARP inhibitors. Approved indications for PARP inhibitors in prostate cancer rely on diagnostic testing for germline or somatic mutations to identify patients suitable for treatment. Accordingly, companion diagnostics have been developed to aid this process, and an up-to-date list of United States Food and Drug Administration (FDA) approved companion diagnostics can be found at www.fda.gov.

Outside of the US, diagnostic testing does not have to be done by specific companies, but can be performed by any certified laboratory.

The European Society for Medical Oncology (ESMO) Clinical Practice Guidelines for prostate cancer recommend somatic testing for homologous recombination repair defects and mismatch repair defects (or microsatellite instability) in patients with mCRPC. They also recommend germline testing in all men with metastatic prostate cancer.[1]. In localised prostate cancer, they suggest that tissue-based molecular assays may be used in conjunction with clinicopathological factors;[1] knowledge of BRCA-status may have a role in active surveillance discussions.

The ESMO Precision Medicine Working Group recommends tumour multigene panel tests for somatic alterations in prostate cancer: in countries where PARP inhibitors are accessible for patients with prostate cancer, it is recommended to perform multigene panel testing on tumour samples to assess the mutational status of, at least, BRCA1/2.[2]

The European Association of Urology-European Association of Nuclear Medicine-European Society for Radiotherapy and Oncology-European Association of Urology Section of Urological Research-International Society of Geriatric Oncology (EAU-EANM-ESTRO-ESUR-ISUP-SIOG) Guidelines on Prostate Cancer strongly recommend offering patients with mCRPC somatic molecular testing to identify patients suitable for treatment with PARP inhibitors.[3] The level of recommendation for germline testing in all men with metastatic prostate cancer in these guidelines is “Weak”.[3]

National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines recommend germline genetic testing for patients with prostate cancer and any of the following:[4]

  • High-risk, very high-risk, regional, or metastatic prostate cancer
  • Ashkenazi Jewish ancestry
  • Family history of high-risk germline mutations (e.g., BRCA1/2, Lynch mutation)
  • A positive family history of cancer

In patients with metastatic prostate cancer, the NCCN guidelines recommend somatic tumour testing to evaluate the tumour for alterations in HRR genes, such as BRCA1, BRCA2, ATM, PALB2, FANCA, RAD51D, CHEK2 and CDK1.[4]

The American Urological Association / American Society for Radiation. Oncology / Society of Urologic Oncology (AUA/ASTRO/SUO) Guideline for advanced prostate cancer recommends that clinicians should offer germline and somatic tumour genetic testing to identify DNA repair deficiency mutations and microsatellite instability status that may inform prognosis in patients with mCRPC and counselling regarding family risk as well as potential targeted therapies.[5]

ESMO Clinical Practice Guidelines [1]

for genomic testing

for specific genes to test

for specimen to test (e.g., tissue, ctDNA)

for germline testing

Consensus
recommendations

Y

Y

x

Y

ESMO Precision Medicine Working Group [2]

for genomic testing

for specific genes to test

for specimen to test (e.g., tissue, ctDNA)

for germline testing

Consensus
recommendations

Y

Y

x

x

EAU-EANM-ESTRO-ESUR-ISUP-SIOG guidelines [3]

for genomic testing

for specific genes to test

for specimen to test (e.g., tissue, ctDNA)

for germline testing

Consensus
recommendations

Y

x

x

Y

NCCN Guidelines [4]

for genomic testing

for specific genes to test

for specimen to test (e.g., tissue, ctDNA)

for germline testing

Consensus
recommendations

Y

Y

x

Y

AUA/ASTRO/SUO Guidelines [5]

for genomic testing

for specific genes to test

for specimen to test (e.g., tissue, ctDNA)

for germline testing

Consensus
recommendations

Y

x

x

Y

AUA/ASTRO/SUO, American Urological Association / American Society for Radiation. Oncology / Society of Urologic Oncology; ctDNA, circulating tumour DNA; EAU-EANM-ESTRO-ESUR-ISUP-SIOG, European Association of Urology-European Association of Nuclear Medicine-European Society for Radiotherapy and Oncology-European Association of Urology Section of Urological Research-International Society of Geriatric Oncology; ESMO, European Society for Medical Oncology; NCCN, National Comprehensive Cancer Network.

Framework for prostate cancer genetic evaluation and management (Adapted from Giri et al. [6])

An ESMO e-learning module with CME accreditation is available in which Dr Llácer Pérez and Dr Castro present insights on the implications of genomic and genetic testing for the management of prostate cancer patients.

View the e-learning module

 

References

[1] Parker C, Castro E, Fizazi K, et al. Prostate cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2020 Sep;31(9):1119-1134.

[2] Mosele F, Remon J, Mateo J, et al. Recommendations for the use of next-generation sequencing (NGS) for patients with metastatic cancers: a report from the ESMO Precision Medicine Working Group. Ann Oncol. 2020 Nov;31(11):1491-1505.

[3] Mottet N, van den Bergh RCN, Briers E, et al. EAU-EANM-ESTRO-ESUR-SIOG Guidelines on Prostate Cancer-2020 Update. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2021 Feb;79(2):243-262.

[4] NCCN Clinical Practice Guidelines in Oncology. Prostate Cancer. Version 2.2021.

[5] Lowrance WT, Breau RH, Chou R, et al. Advanced Prostate Cancer: AUA/ASTRO/SUO Guideline PART II. J Urol. 2021 Jan;205(1):22-29.

[6] Giri VN, Knudsen KE, Kelly WK, et al. Implementation of germline testing for prostate cancer: Philadelphia Prostate Cancer Consensus Conference 2019. J Clin Oncol. 2020 Aug 20;38(24):2798-2811.

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