Biomarker · Other

AR-V7 splice variant

A constitutively active androgen receptor splice variant lacking the ligand-binding domain, detected in circulating tumor cells or tissue by RT-PCR or immunostaining; studied as a predictive marker of resistance to AR-pathway inhibitors in castration-resistant prostate cancer.

CI-BIO-00000037AR graph →NCIt C135616

Also calledAR-V7 · androgen receptor variant 7 · AR splice variant 7

Derived

Associated cancers (1)

Cancers mapped in ACCEPTED CIViC predictive, prognostic or diagnostic items whose variant (molecular markers) or gene (gene-level markers) is in this biomarker's scope. Counts by type and native level; each row links to the cancer's evidence tab.

Computedrule biomarker-links-v1

Cancer	Items	Predictive	Prognostic	Diagnostic	Levels A / B / C / D / E
Malignant Prostate Neoplasm	4	4	—	—	0 / 4 / 0 / 0 / 0

Derived

Drugs with predictive evidence (2)

Therapies named in in-scope PREDICTIVE CIViC items, plus targets of PREDICTS_RESPONSE_TO knowledge edges from in-scope variants. Sensitivity and resistance are counted separately and never merged into a verdict.

Computedrule biomarker-links-v1

Drug	CIViC items	Sensitivity	Resistance	Best level	Edges (S / R)	Cancer context
AbirateroneSmall Molecule	4	—	4	B	0 / 4	Malignant Prostate Neoplasm
EnzalutamideSmall Molecule	4	—	4	B	0 / 4	Malignant Prostate Neoplasm

Curated items and knowledge edges as curated at the source.

Curated evidence

Predictive evidence items (4)

ACCEPTED CIViC predictive items in scope, grouped by molecular profile and therapy with native level, direction and cancer context. 50 per page.

civicCuratedShowing 1–4 of 4 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
AR AR-V74
Abiraterone +

Regulatory

Approvals mentioning the linked drugs (43)

Approval records of the derived drug set, plus records whose indication text names this biomarker. Each record names its authority, jurisdiction, indication text and status — a drug approved in one jurisdiction for one indication is not 'approved' in general, and an approval listed here is not necessarily restricted to this biomarker.

Computedrule biomarker-links-v1

ema

Clinical trials

Active trials (54)

Trials with an active ClinicalTrials.gov status, an intervention mapped to a derived drug and a condition mapped to an associated cancer. 28 recruiting · 9 active phase 3 · 165 in any status. Most recently updated first, 50 per page.

Computedrule biomarker-links-v1

clinicaltrialsPublishedShowing 1–50 of 54 active studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT07028853	This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide Will Work Better Than Taking Enzalutamide Alone in Participants With mCSPC Who Are ARPI naïve.	recruiting

Literature

Linked publications (7)

Publications linked to the scope variant(s) through PubMed entity edges; 25 per page, newest first.

pubmedPublishedShowing 1–7 of 7 publications · bibliographic data as recorded by PubMed; abstracts are not reproduced.

Prospective Multicenter Validation of Androgen Receptor Splice Variant 7 and Hormone Therapy Resistance in High-Risk Castration-Resistant Prostate Cancer: The PROPHECY Study.
· J Clin Oncol · 2019 · PMID 30865549 · validated civic_curation pubmed
Association of AR-V7 on Circulating Tumor Cells as a Treatment-Specific Biomarker With Outcomes and Survival in Castration-Resistant Prostate Cancer.
· JAMA Oncol · 2016 · PMID 27262168 · validated civic_curation pubmed
Assessment of the Validity of Nuclear-Localized Androgen Receptor Splice Variant 7 in Circulating Tumor Cells as a Predictive Biomarker for Castration-Resistant Prostate Cancer.
· JAMA Oncol · 2018 · PMID 29955787 · validated civic_curation pubmed
AR-V7 and resistance to enzalutamide and abiraterone in prostate cancer.

Drug	Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
Abiraterone	EU EMA	Castration-Resistant Prostate Carcinoma	Abiraterone Accord is indicated with prednisone or prednisolone for: the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.	approved	Apr 26, 2021	ema
Abiraterone	EU EMA	Castration-Resistant Prostate Carcinoma	Zytiga is indicated with prednisone or prednisolone for: the treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated the treatment of metastatic castration resistant prostate cancer in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.accelerated	approved	Sep 5, 2011	ema
Abiraterone	US FDA	—	Efficacy supplement 2019-06-03 (see label)	approved	Jun 3, 2019	openfda
Abiraterone	US FDA	Castration-Resistant Prostate Carcinoma	Abiraterone Acetate is indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer. Abiraterone Acetate is a CYP17 inhibitor indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). ( 1 )	approved	May 22, 2018	openfda
Abiraterone	US FDA	—	Efficacy supplement 2018-02-07 (see label)	approved	Feb 7, 2018	openfda
Abiraterone	US FDA	—	Efficacy supplement 2015-03-20 (see label)	approved	Mar 20, 2015	openfda
Abiraterone	US FDA	—	Efficacy supplement 2012-12-10 (see label)	approved	Dec 10, 2012	openfda
Abiraterone	US FDA	—	ZYTIGA is indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC) Metastatic high-risk castration-sensitive prostate cancer (CSPC) ZYTIGA is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). ( 1 ) metastatic high-risk castration-sensitive prostate cancer (CSPC). ( 1 )	approved	Apr 28, 2011	openfda
Enzalutamide	CA Health Canada	—	Marketed in Canada as AURO-ENZALUTAMIDE (DIN 02494736) under ATC L02BB04 ENZALUTAMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Mar 30, 2026	health-canada-dpd
Enzalutamide	CA Health Canada	—	Marketed in Canada as REDDY-ENZALUTAMIDE (DIN 02558424) under ATC L02BB04 ENZALUTAMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Mar 30, 2026	health-canada-dpd
Enzalutamide	CA Health Canada	—	Marketed in Canada as APO-ENZALUTAMIDE (DIN 02562677) under ATC L02BB04 ENZALUTAMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Mar 30, 2026	health-canada-dpd
Enzalutamide	CA Health Canada	—	Marketed in Canada as JAMP ENZALUTAMIDE (DIN 02515229) under ATC L02BB04 ENZALUTAMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Feb 20, 2026	health-canada-dpd
Enzalutamide	CA Health Canada	—	Marketed in Canada as XTANDI (DIN 02407329) under ATC L02BB04 ENZALUTAMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jun 7, 2013	health-canada-dpd
Enzalutamide	CA Health Canada	—	Marketed in Canada as PMS-ENZALUTAMIDE (DIN 02570831) under ATC L02BB04 ENZALUTAMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Enzalutamide	CA Health Canada	—	Marketed in Canada as PRO-ENZALUTAMIDE (DIN 02569124) under ATC L02BB04 ENZALUTAMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Enzalutamide	EU EMA	Castration-Resistant Prostate Carcinoma	Enzalutamide Viatris is indicated:• as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy (see section 5.1);• in combination with androgen deprivation therapy for the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) (see section 5.1); • for the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1);• for the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1);• for the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.	approved	Aug 22, 2024	ema
Enzalutamide	EU EMA	Castration-Resistant Prostate Carcinoma	Xtandi is indicated for: as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high risk biochemical recurrent (BCR) non-metastatic hormone sensitive prostate cancer (nmHSPC) who are unsuitable for salvage radiotherapy (see section 5.1). the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (see section 5.1). the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1). the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1). the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.	approved	Jun 21, 2013	ema
Enzalutamide	EU EMA	Malignant Prostate Neoplasm	Treatment of prostate cancer.	approved	—	ema
Enzalutamide	US FDA	—	Efficacy supplement 2026-07-24 (see label)	approved	Jul 24, 2026	openfda
Enzalutamide	US FDA	—	Efficacy supplement 2026-07-24 (see label)	approved	Jul 24, 2026	openfda
Enzalutamide	US FDA	—	Efficacy supplement 2023-11-16 (see label)	approved	Nov 16, 2023	openfda
Enzalutamide	US FDA	—	Efficacy supplement 2023-11-16 (see label)	approved	Nov 16, 2023	openfda
Enzalutamide	US FDA	—	Efficacy supplement 2022-09-09 (see label)	approved	Sep 9, 2022	openfda
Enzalutamide	US FDA	—	Efficacy supplement 2022-09-09 (see label)	approved	Sep 9, 2022	openfda
Enzalutamide	US FDA	—	Efficacy supplement 2020-10-23 (see label)	approved	Oct 23, 2020	openfda
Enzalutamide	US FDA	Nonmetastatic Castration-Sensitive Prostate Carcinoma	non‑metastatic castration‑sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR) XTANDI is an androgen receptor inhibitor indicated for the treatment of patients with:	approved	Aug 4, 2020	openfda
Enzalutamide	US FDA	Malignant Prostate Neoplasm	metastatic castration-sensitive prostate cancer (mCSPC)	approved	Aug 4, 2020	openfda
Enzalutamide	US FDA	Malignant Prostate Neoplasm	non‑metastatic castration‑sensitive prostate cancer with biochemical recurrence at high risk for metastasis. ( 1 )	approved	Aug 4, 2020	openfda
Enzalutamide	US FDA	Malignant Prostate Neoplasm	metastatic castration-sensitive prostate cancer. ( 1 )	approved	Aug 4, 2020	openfda
Enzalutamide	US FDA	Castration-Resistant Prostate Carcinoma	castration-resistant prostate cancer. ( 1 )	approved	Aug 4, 2020	openfda
Enzalutamide	US FDA	Castration-Resistant Prostate Carcinoma	castration-resistant prostate cancer (CRPC)	approved	Aug 4, 2020	openfda
Enzalutamide	US FDA	—	Efficacy supplement 2019-12-16 (see label)	approved	Dec 16, 2019	openfda
Enzalutamide	US FDA	—	Efficacy supplement 2018-07-13 (see label)	approved	Jul 13, 2018	openfda
Enzalutamide	US FDA	—	Efficacy supplement 2017-07-24 (see label)	approved	Jul 24, 2017	openfda
Enzalutamide	US FDA	—	Efficacy supplement 2016-10-20 (see label)	approved	Oct 20, 2016	openfda
Enzalutamide	US FDA	—	Efficacy supplement 2015-07-21 (see label)	approved	Jul 21, 2015	openfda
Enzalutamide	US FDA	—	Efficacy supplement 2014-09-10 (see label)	approved	Sep 10, 2014	openfda
Enzalutamide	US FDA	Castration-Resistant Prostate Carcinoma	castration-resistant prostate cancer (CRPC)	approved	Aug 31, 2012	openfda
Enzalutamide	US FDA	Malignant Prostate Neoplasm	metastatic castration-sensitive prostate cancer (mCSPC)	approved	Aug 31, 2012	openfda
Enzalutamide	US FDA	Nonmetastatic Castration-Sensitive Prostate Carcinoma	non‑metastatic castration‑sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR) XTANDI is an androgen receptor inhibitor indicated for the treatment of patients with:	approved	Aug 31, 2012	openfda
Enzalutamide	US FDA	Malignant Prostate Neoplasm	non‑metastatic castration‑sensitive prostate cancer with biochemical recurrence at high risk for metastasis. ( 1 )	approved	Aug 31, 2012	openfda
Enzalutamide	US FDA	Malignant Prostate Neoplasm	metastatic castration-sensitive prostate cancer. ( 1 )	approved	Aug 31, 2012	openfda
Enzalutamide	US FDA	Castration-Resistant Prostate Carcinoma	castration-resistant prostate cancer. ( 1 )	approved	Aug 31, 2012	openfda

Drug

Jurisdiction · authority

Cancer

Indication

Status

Approval date

Source

Abiraterone

EU EMA

Castration-Resistant Prostate Carcinoma

Abiraterone Accord is indicated with prednisone or prednisolone for: the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

approved

Apr 26, 2021

ema

Abiraterone

EU EMA

Castration-Resistant Prostate Carcinoma

Zytiga is indicated with prednisone or prednisolone for: the treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated the treatment of metastatic castration resistant prostate cancer in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.accelerated

approved

Sep 5, 2011

ema

Abiraterone

US FDA

—

Efficacy supplement 2019-06-03 (see label)

approved

Jun 3, 2019

openfda

Abiraterone

US FDA

Castration-Resistant Prostate Carcinoma

Abiraterone Acetate is indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer. Abiraterone Acetate is a CYP17 inhibitor indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). ( 1 )

approved

May 22, 2018

openfda

Abiraterone

US FDA

—

Efficacy supplement 2018-02-07 (see label)

approved

Feb 7, 2018

openfda

Abiraterone

US FDA

—

Efficacy supplement 2015-03-20 (see label)

approved

Mar 20, 2015

openfda

Abiraterone

US FDA

—

Efficacy supplement 2012-12-10 (see label)

approved

Dec 10, 2012

openfda

Abiraterone

US FDA

—

ZYTIGA is indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC) Metastatic high-risk castration-sensitive prostate cancer (CSPC) ZYTIGA is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). ( 1 ) metastatic high-risk castration-sensitive prostate cancer (CSPC). ( 1 )

approved

Apr 28, 2011