Prostate cancer and PARP inhibitors: progress and challenges

Teyssonneau, Diego; Margot, Henri; Cabart, Mathilde; Anonnay, Mylène; Sargos, Paul; Vuong, Nam-Son; Soubeyran, Isabelle; Sevenet, Nicolas; Roubaud, Guilhem

doi:10.1186/s13045-021-01061-x

Journal of Hematology & Oncology

Table 1 Phase II or III trials using PARP inhibitors alone to treat prostate cancers

From: Prostate cancer and PARP inhibitors: progress and challenges

CTID	Treatment	Phase	No. patients or estimated enrollment	Disease status	Mandatory HRR status for inclusion	Determination method for HRD	Primary endpoints	Results
NCT01682772/TOPARP-A	Olaparib	2	50	mCRPC after at least docetaxel	No	Tumor	Composite response rate^b	All comers: 33% HRD: 88%
NCT01682772/TOPARP-B	Olaparib	2	98	mCRPC after at least docetaxel	Bi-allelic deleterious HRD	Tumor	Composite response rate^b Preplanned secondary endpoint: ORR	BRCA1/2: 83%, ORR: 52.4% PALB2: 57%, ORR: 33.3% ATM: 37%, ORR: 8.3% CDK12: 25%, ORR: 0%
NCT02987543/PROfound	Olaparib versus NHT	3	778	mCRPC after at least 1 NHT	Bi- or mono-allelic somatic or germline deleterious HRD	Tumor	Radiographic PFS Preplanned secondary endpoint: OS	rPFS: BRCA/ATM: 7.4 months versus 3.6mo, HR = 0.34 (95% CI 0.25–0.47) General HRD: 5.8 months versus 3.5 months, HR = 0.49 (95% CI 0.38–0.63) OS: BRCA/ATM: 19.1 months versus 14.7 months HR = 0.69 (CI 95% 0.5–0.97) No-BRCA/ATM: 14.1 months versus 11.5 months HR = 0.96 (CI 95% 0.63–1.49)
NCT03432897/BrUOG-337	Olaparib	2	13	High-risk localized PC	Deleterious HRD^a	Tumor or plasma	PSA response rate prior prostatectomy	Recruiting
NCT03047135	Olaparib	2	50	Castration Sensitive Biochemically Recurrent nmPC	No	Undescribed method	PSA response rate	Recruiting
NCT03434158 /IMANOL	Olaparib as maintenance therapy after docetaxel	2	27	mCRPC after at least docetaxel	Deleterious HRD^a	Undescribed method	Radiographic PFS	Recruiting
NCT03012321/BRCAAway	Olaparib versus abiraterone versus abiraterone + olaparib	2	70	mCRPC, 1st line	No	Tumor	PFS	Recruiting
NCT03263650	Olaparib maintenance after cabazitaxel–carboplatin combination	2	123	Aggressive variant PC	No	Not performed	PFS	Ongoing, not recruiting
NCT02854436/GALAHAD	Niraparib	2	291	mCRPC after at least 1 chemotherapy and 1 NHT	Bi-allelic HRD or germline pathogenic BRCA1/2 alteration^b	Tumor or plasma	ORR	BRCA: 41% Non-BRCA: 9%
NCT04288687	Niraparib	2	18	mCRPC, platine sensitivity	Deleterious HRD^a	Undescribed method	Radiographic PFS	Not yet recruiting
NCT04037254	ADT (24 months) + RT + niraparib (12 months)	2	180	High-risk localized PC	No	Not performed	Disease-free survival	Ongoing, not recruiting
NCT04030559	Niraparib for 3 months	2	30	High-risk localized PC, prior prostatectomy	Bi- or mono-allelic deleterious HRD	Undescribed method	Pathologic response rate	Recruiting
NCT02952534/TRITON-2	Rucaparib	2	193	mCRPC after at least 1 chemotherapy and 1 NHT	Bi- or mono-allelic somatic or germline deleterious HRD	Tumor or plasma	ORR and PSA response rate (PRR)	sBRCA1/2: 43.9%, PRR: 50.7% gBRCA1/2: 42.9%, PRR: 61.4% ATM: 10.5%, PRR: 4.1% CDK12: 0%, PRR: 6.7% CHEK12: 11.1%, PRR: 16.7%
NCT02975934/TRITON-3	Rucaparib versus NHT or docetaxel	3	400	mCRPC, after 1 NHT, 0 chemotherapy	Deleterious BRCA1/2 or ATM alteration^a	Undescribed method	Radiographic PFS	Recruiting
NCT03413995/TRIUMPH	Rucaparib	2	30	mCSPC unfit/unwilling ADT	Germline HRD alteration^b	Undescribed method	PSA response rate	Recruiting
NCT03442556/PLATI-PARP	Rucaparib maintenance after docetaxel–carboplatin combination	2	20	mCRPC	Bi- or mono-allelic deleterious HRD	Tumor or plasma	Radiographic PFS	Recruiting
NCT03533946/ROAR	Rucaparib	2	32	nmCSPC	Deleterious HRD^a	Tumor or plasma	PSA response rate	Recruiting
NCT03148795/TALAPRO-1	Talazoparib	2	100	mCRPC after at least 1 chemotherapy and 1 NHT	Mono- or bi-allelic HRD (CDK12 excluded)	Tumor	ORR	BRCA: 50% ATM: 7% Other HRD: 0%

ATM: ataxia telangiectasia mutated, sBRCA: somatic deleterious mutation of BRCA. gBRCA: germinal deleterious mutation of BRCA, mCRPC metastatic castration-resistant prostate cancer, mCSPC metastatic castration-sensitive prostate cancer, nmPC non-metastatic prostate cancer, nmCSPC non-metastatic castration-sensitive prostate cancer, ADT androgen deprivation therapy, NHT new hormonal therapy, HRR homologous recombination repair, HRD homologous repair deficiency, CTID clinical trial identification, PC prostate cancer, PFS progression free survival, ORR objective response rate, PSA response rate: decline of more than 50%, RT radiotherapy
^aMono- or bi-allelic status not specified
^bGermline or somatic alteration specified
^cComposite response rate: response according to RECIST or PSA reduction > 50%, or reduction of circulating tumor cells to less than 5/7.5 mL of blood confirmed 4 weeks later

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ISSN: 1756-8722

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