HRR Mutations, including BRCA1/2 in Prostate Cancer

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Prostate Cancer
HRR Mutations

HRR Mutations

Jump to:

Clinical Relevance
Testing Recommendations
Prevalence
Sample Type Considerations
Plasma ctDNA
Diagnostic Assays
Interpreting & Reporting
Considerations for Your Practice
Helpful Resources

Clinical Relevance of HRR Mutations, Including BRCA1/2

In the presence of homologous recombination repair (HRR) gene mutations, tumor cells are unable to effectively repair double-strand breaks (DSBs) in DNA, leading to the persistence of DSBs, accumulation of mutations, and ultimately, carcinogenesis.^1,2 In prostate cancer, one way to assess HRRm status is through individual mutations in BRCA1 or BRCA2.³

Patients with metastatic prostate cancer and certain HRR mutations risk poorer
outcomes^4,5

Graph showing the median survival time for patients with BRCA1, BRCA2 or ATM mutations as three years whereas for patients without BRCA1, BRCA2 or ATM mutations the median survival time is six years.

Median survival time for patients with and without BRCA1, BRCA2, or ATM mutations⁴

BRCA1, BRCA2, or ATM mutations (n=10)

3
years

No mutations (n=112)

6
years

Median survival time (years)

ATM, ataxia-telangiectasia mutated; BRCA1/2, BReast CAncer susceptibility gene 1/2; DNA, deoxyribonucleic acid; DSB, double-strand break; HRR, homologous recombination repair.

HRR Mutation Testing Recommendations

NCCN Clinical Practice Guidelines In Oncology (NCCN Guidelines^®) for Prostate Cancer recommend tumor testing for all patients with metastatic prostate cancer³

Why test³	Whom to test³	What to test³	How to test⁶
To aid in treatment decisions, clinical trial enrollment, and/or familial risk counseling	All patients with metastatic prostate cancer at metastatic or initial diagnosis	Somatic HRR gene mutations^a including BRCA1/2	FDA-approved assay: FoundationOne^®CDx (Foundation Medicine, Inc.)
		Germline mutations in BRCA1/2	FDA-approved assay: BRACAnalysis CDx^® (Myriad Genetic Laboratories, Inc.)
		When metastatic biopsy is unsafe or unfeasible, ctDNA assay is an option	FDA-approved assay: FoundationOne^® Liquid CDx (Foundation Medicine, Inc.)

Why test³

Whom to test³

What to test³

How to test⁶

To aid in treatment decisions, clinical trial enrollment, and/or familial risk counseling

All patients with metastatic prostate cancer at metastatic or initial diagnosis

Somatic HRR gene mutations^a including BRCA1/2

FDA-approved assay:

FoundationOne^®CDx
(Foundation Medicine, Inc.)

Germline mutations in BRCA1/2

FDA-approved assay:

BRACAnalysis CDx^®
(Myriad Genetic Laboratories, Inc.)

When metastatic biopsy is unsafe or unfeasible, ctDNA assay is an option

FDA-approved assay:

FoundationOne^® Liquid CDx (Foundation Medicine, Inc.)

This document is intended as educational information and is not intended as a complete list of available testing options. AstraZeneca is not responsible for any test provider and does not endorse any particular diagnostic test. The accuracy and results of diagnostic tests vary, and AstraZeneca shall have no liability arising from such testing. Information provided herein should in no way be considered a guarantee of coverage, reimbursement, or patient assistance. Providers should contact third-party laboratories for information on their patient assistance programs. While diagnostic testing may assist providers in identifying appropriate treatment for patients, the decision and action should be decided by a provider in consultation with the patient. All products are trademarks of their respective holders, all rights reserved.

^aHRR genes such as: BRCA1, BRCA2, ATM, PALB2, FANCA, RAD51D, CHEK2, and CDK12.³

ATM, ataxia-telangiectasia mutated; BRCA1/2, BReast CAncer susceptibility gene 1/2; CDK12, cyclin-dependent kinase 12; CDx, companion diagnostic; CHEK2, checkpoint kinase 2; ctDNA, circulating tumor deoxyribonucleic acid; FANCA, fanconi anemia complementation group A; FDA, US Food and Drug Administration; HRRm, homologous recombination repair mutation; NCCN, National Comprehensive Cancer Network^® (NCCN^®); PALB2, partner and localizer of BRCA2; RAD51D, RAD51 paralog D.

Nearly a Third of Patients Have an HRR Mutation⁷

~15% of patients have BRCA1/2 mutations⁷

A retrospective multicenter observational cohort study of patients with advanced prostate cancer in the United States from 2013 to 2019⁷
674 patients were tested for 1 or more of 6 HRR gene mutations of interest – ATM, BRCA1, BRCA2, CDK12, PALB2, and FANCA⁷

As supported by real-world evidence, a substantial proportion of patients with advanced prostate cancer may have an HRR gene alteration^7,8

Prevalence of specific
HRR gene alterations (%)

15 12 9 6 3 0

BRCA2

13.4%

(n=604)

CDK12

7.7%

(n=273)

ATM

6.2%

(n=531)

BRCA1

2.8%

(n=603)

PALB2

1.9%

(n=424)

FANCA

1.6%

(n=251)

Overall,

23.7%

of patients tested
positive for ≥1 HRR
gene mutation of
interest.⁷

In a separate study, real-world data were analyzed from routine prospective clinical genomic profiling in a US institution⁸

Using a validated assay of 395 genes (including BRCA1/2, CDK12, ATM, CHEK2, FANCA, and ATR, among others) on 3,476 unmatched primary and metastatic prostate cancer tissue samples, DNA repair pathway genomic alterations were identified in 31% of samples⁸

ATM, ataxia-telangiectasia mutated; ATR, ataxia telangiectasia and Rad3-related; BRCA1/2, BReast CAncer susceptibility gene 1/2; CDK12, cyclin-dependent kinase 12; CHEK2, checkpoint kinase 2; FANCA, Fanconi anemia group A; HRR, homologous recombination repair; HRRm, homologous recombination repair mutations; PALB2, partner and localizer of BRCA2.

Sample Type Determines Somatic and/or Germline HRR Mutation Identification

Infographic showcasing the mutations which may be identified using tumor tissue or blood samples.

Tumor Tissue Sample

Germline and somatic^a

HRR gene panel^9,10,b (includes BRCA1 and BRCA2)

~28% of men

BRCA1 and BRCA2¹¹

~10% of men

Among men with mCRPC who were prospectively screened for HRR gene alterations for a large prospective study (biomarker status reported for 2,792 patients)¹⁰

Blood Sample

Germline

BRCA1 and BRCA2¹²

~6% of men

In a systematic review, BRCA1/2 germline mutations were determined from peripheral blood of 1,038 patients with mCRPC¹²

Sample type	Type of mutation identified	Special considerations/limitations
Tumor tissue¹³	Germline and somatic mutations	Positive results should be followed by familial risk assessment (germline testing) Tissue testing does not distinguish between somatic and germline mutations
Plasma ctDNA^14,15	Germline and somatic mutations	Dependent on adequate levels of ctDNA Does not distinguish between somatic and germline mutations
Blood or saliva¹⁶	Germline mutations	Does not identify somatic mutations May have familial implications

Tumor testing identifies both germline and somatic mutations, without differentiation^7,13,16

Tissue samples may be collected from the primary tumor site or sites of metastasis¹³

The TRUS-guided 12-core systematic biopsy method is considered gold standard for prostate tissue sample collection; however, this may yield false negatives¹⁷
Interventional radiologists use imaging to guide biopsy collection from a non-bone metastatic site¹⁸
Bone-only metastases are often sclerotic and require decalcification. Bone scans and CT imaging can identify lesions more suitable for biopsy¹⁹
In the event of failed tissue acquisition, archival tissue samples may be used; however, they may not reflect the current tumor molecular status¹³

Consider Plasma ctDNA if Tumor Tissue Is Unavailable

Minimally invasive option to assess HRRm in mCRPC²⁰
As the amount of ctDNA may correlate with disease progression, sample collection should coincide with progressive disease and not during therapeutic response^20–22
High concordance between ctDNA and tissue testing for BRCA1, BRCA2, and ATM¹⁵

Infographic demonstrating that results from ctDNA testing alone is actionable.

A Positive
mutation result from ctDNA testing alone is actionable^15,21

A Negative
result requires confirmation with tissue-based testing^15,21

A Positive
mutation result from ctDNA testing alone is actionable^15,21

A Negative
result requires confirmation with tissue-based testing^15,21

Perform germline testing to assess familial risk, if tumor test is HRRm-positive^13,16,23,24

Germline and somatic HRR mutations in patients with advanced prostate cancer are associated with shorter survival time than those without such mutations.^4,5 As BRCA1/2 mutations in prostate cancer can be either germline or somatic, testing for both identifies all patients affected.

^aTumor testing cannot distinguish between germline and somatic mutations.^{9 b}Gene panel testing was conducted in a large prospective study to identify the following genes in the DNA repair process: ATM, BRCA1, BRCA2, BRIP1, BARD1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, and RAD54L.¹⁰

ATM, ataxia-telangiectasia mutated; BRCA1/2, BReast CAncer susceptibility gene 1/2; CDK12, cyclin-dependent kinase 12; CHEK1/2, checkpoint kinase 1 and/or 2; CT, computed tomography; ctDNA, circulating tumor deoxyribonucleic acid; FANCL, fanconi anemia complementation group L; HRR, homologous recombination repair; mCRPC, metastatic castration-resistant prostate cancer; PALB2, partner and localizer of BRCA2; RAD51B/C/D, RAD51 paralog B, C and/or D; RAD54L, RAD54 paralog L; TRUS, transrectal ultrasound scan.

Diagnostic Assays for HRR Mutations, Including BRCA1/2 Mutations

Results can take between 7 to 21 days from receiving samples

Tissue testing

Laboratory and test name	FDA approval	Genes or alterations assessed	Minimum sample requirements	Turnaround time
Caris^25-27 Molecular Intelligence^® Tumor Seek™ (NGS analysis)	No	HRRm (including BRCA1/2), dMMR, MSI	FFPE block or 10 unstained slides (positively charged, unbaked) with a ≥20% tumor nuclei. Needle biopsy (4–6 cores), FNA, malignant fluid cell block, and bone/bone metastasis are also acceptable	~10–14 days
Foundation Medicine^9,28,29 FoundationOne^® CDx	Yes	HRRm (including BRCA1/2), dMMR, MSI	1 block + 1 H&E slide OR 10 unstained slides (positively charged and unbaked at 4–5 microns thick) + 1 H&E slide	≤12 days from receipt
NeoGenomics³⁰ NeoTYPE^® HRR Profile	No	HRRm (including BRCA1/2)	Paraffin block preferred	14 days
NeoGenomics³¹ BRCA1/2 Mutations Analysis for Tumors	No	BRCA1/2	Paraffin block is preferred OR 1 H&E slide + 5–10 unstained slides (positively charged) cut at ≥5 microns	14 days
Tempus^32-35 Tempus xT (Solid tumor)	No	HRRm (BRCA1/2), dMMR, MSI	FFPE block with a minimum of 20% tumor content	9 days from receipt

AstraZeneca is not affiliated with and does not control these websites. Inclusion of a website on AZPrecisionMed.com does not constitute endorsement of its content by the associated organizations. This document is intended as educational information and is not intended as a complete list of available testing options. AstraZeneca is not responsible for any test provider and does not endorse any particular diagnostic test. The accuracy and results of diagnostic tests vary, and AstraZeneca shall have no liability arising from such testing. Information provided herein should in no way be considered a guarantee of coverage, reimbursement, or patient assistance. Providers should contact third-party laboratories for information on their patient assistance programs. While diagnostic testing may assist providers in identifying appropriate treatment for patients, the decision and action should be decided by a provider in consultation with the patient. All products are trademarks of their respective holders, all rights reserved.

BRCA1/2, BReast CAncer susceptibility gene 1/2; CDx, companion diagnostic; dMMR, deficient mismatch repair; DNA, deoxyribonucleic acid; FDA, US Food and Drug Administration; FFPE, formalin-fixed paraffin-embedded; FNA, fine needle aspiration; H&E, hematoxylin and eosin; HRRm, homologous recombination repair mutation; MSI, microsatellite instability.

Plasma (ctDNA) testing

Laboratory and test name	FDA approval	Genes or alterations assessed	Minimum sample requirements	Turnaround time
Foundation Medicine^36-38 FoundationOne^® Liquid CDx	Yes	HRRm (including BRCA1/2), dMMR, MSI	2 tubes of peripheral whole blood (8.5 mL per tube)	≤10 days from receipt
Tempus^39,40 Tempus xF	No	2 Streck tubes of peripheral blood (8.5 mL per tube)	7 days from receipt
Guardant Health^41,42 Guardant360^® CDx	No	HRRm (including BRCA1/2), dMMR	≥5 mL whole blood in Streck Cell-Free DNA BCT^®	7 days

Laboratory and
test name

FDA approval

Genes or alterations
assessed

Minimum sample
requirements

Turnaround time

Foundation Medicine^36-38

FoundationOne^®
Liquid CDx

Yes

HRRm (including BRCA1/2), dMMR, MSI

2 tubes of peripheral whole blood (8.5 mL per tube)

≤10 days from receipt

Tempus^39,40

Tempus xF

2 Streck tubes of peripheral blood (8.5 mL per tube)

7 days from receipt

Guardant Health^41,42

Guardant360^® CDx

HRRm (including BRCA1/2), dMMR

≥5 mL whole blood in Streck Cell-Free DNA BCT^®

7 days

BCT, blood collection tube; BRCA1/2, BReast CAncer susceptibility gene 1/2; CDx, companion diagnostic; ctDNA, circulating tumor deoxyribonucleic acid; dMMR, deficient mismatch repair; DNA, deoxyribonucleic acid; FDA, US Food and Drug Administration; HRRm, homologous recombination repair mutation; MSI, microsatellite instability.

Germline testing

Laboratory and test name	FDA approval	Genes or alterations assessed	Minimum sample requirements	Turnaround time
Ambry^43-45 Cancer Next^®	Yes		3–4 mL whole blood, EDTA tube (purple top) or PAXgene^® DNA tube (blue top) preferred^a	14–21 days
GenPath^46-48 OnkoRisk^™ Oncology Management Panel	No		2–5 mL whole blood, lavender-top EDTA tube	14 days
GeneDx^49,50 OncoGene Dx: Hereditary Prostate Cancer Panel	No	HRRm (including BRCA1/2), dMMR	2–5 mL blood, lavender-top tube	2 weeks
Invitae^51,52 Common Hereditary Cancers Panel	No		3 mL whole blood in a purple-top EDTA tube	10–21 calendar days
Invitae^53,54 Multi-Cancer Panel	No		3 mL whole blood in a purple-top EDTA tube	10–21 calendar days
Myriad^55,56 BRACAnalysis CDx^® (BRCA1/BRCA2)	Yes	BRCA1/2	~7 mL peripheral whole blood in a BCT-containing EDTA	<2 weeks
Myriad^57-59 MyRisk^® Hereditary Cancer	No	HRRm (including BRCA1/2), dMMR	7 mL peripheral blood or buccal saliva sample	≤14 days
Tempus xG^33,60,61 (powered by GeneDx) Common Hereditary Cancers	No	HRRm (including BRCA1/2), dMMR	8 mL peripheral blood in a lavender-top EDTA tube or buccal saliva sample	14–21 days from receipt

^aNGS sequencing panels and clinical exome sequencing require 6–10 mL.⁴³

BCT, blood collection tube; BRCA1/2, BReast CAncer susceptibility gene 1/2; CDx, companion diagnostic; dMMR, deficient mismatch repair; DNA, deoxyribonucleic acid; EDTA, ethylenediaminetetraacetic acid; FDA, US Food and Drug Administration; HRRm, homologous recombination repair mutation; NGS, next-generation sequencing.

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This information is intended as educational and is not intended as a complete list of available testing options. AstraZeneca is not responsible for any test provider and does not endorse any particular diagnostic test. The accuracy and results of diagnostic tests vary, and AstraZeneca shall have no liability arising from such testing. Information provided herein should in no way be considered a guarantee of coverage, reimbursement, or patient assistance. Providers should contact third-party laboratories for information on their patient assistance programs. While diagnostic testing may assist providers in identifying appropriate treatment for patients, the decision and action should be decided by a provider in consultation with the patient. All products are trademarks of their respective holders, all rights reserved.

Interpreting and Reporting Biomarker Test Results

HRRm testing aids in systemic treatment decisions, clinical trial enrollment, and/or genetic counseling on familial risk⁶²

Testing for HRRm, including BRCA1/2, may:

Reveal patients who have an increased risk for hereditary cancers.^63,64 Genetic counselors may be required to discuss germline testing in the pre-test setting, allowing patients to make informed decisions. Genetic counselors also play a key role in evaluating genetic testing results⁶⁴

Offer prognostic insights on patients with metastatic prostate cancer and mutations in genes such as BRCA1/2 who are at risk for more aggressive disease and poorer outcomes^4,65

Interpreting and Reporting Biomarker Test Results

Provide predictive insights which aid in the development of a comprehensive treatment plan^66,67

Open opportunities for patients to be enrolled onto clinical trials to receive upcoming, biomarker-specific treatments⁶²

BRCA1/2, BReast CAncer susceptibility gene 1/2; HRRm, homologous recombination repair mutation.

Considerations for Your Practice

Consider HRRm status for treatment decision-making, clinical trial enrollment, and genetic counseling:

Test for HRRm at metastatic diagnosis
Re-evaluate HRR genes upon progression
Consider sample type and age when using tumor tissue for HRRm testing
Utilize plasma ctDNA testing for cases where tumor testing is not feasible
Explore solutions to common challenges you may face

ctDNA, circulating tumor deoxyribonucleic acid; HRRm, homologous recombination repair mutation.

Helpful Resources

Check out these featured resources on precision medicine in prostate cancer.

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HRR Mutations, Including BRCA1/2 in Prostate Cancer

Clinical Relevance of HRR Mutations, Including BRCA1/2

HRR Mutation Testing Recommendations

Footnotes

Nearly a Third of Patients Have an HRR Mutation7

Sample Type Determines Somatic and/or Germline HRR Mutation Identification

Consider Plasma ctDNA if Tumor Tissue Is Unavailable

Footnotes

Diagnostic Assays for HRR Mutations, Including BRCA1/2 Mutations

Footnotes

Interpreting and Reporting Biomarker Test Results

Considerations for Your Practice

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What is an AstraZeneca authorised person?

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Nearly a Third of Patients Have an HRR Mutation⁷