Panoramica

Idoneità

Dettagli del Disegno

Bracci e Interventi

Misure di Esito

Siti dello Studio

Fonte: NCT06855277

Reclutamento in corso

AcTFirst: Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC

Interventistico

Fase 3

Medical College of Wisconsin

Sponsor: Novartis

Ultimo Aggiornamento: 24 febbraio 2026
Avviso - Le informazioni provengono da registri pubblici e potrebbero non riflettere i cambiamenti in tempo reale presso il centro locale.

The purpose of this study is to determine whether [225Ac]Ac-PSMA-617 (AAA817), given for up to 6 cycles at a dose of 10 Megabecquerel (MBq) +/- 10%, plus androgen receptor pathway inhibitor (ARPI), improves the radiographic progression free survival (rPFS) compared to investigator's choice of standard of care (SOC) (ARPI change or taxane-based chemotherapy or [177Lu]Lu-PSMA-617 (AAA617)) in adult participants with PSMA-positive metastatic castration resistant prostate cancer (mCRPC) treated with another ARPI as last treatment and who have not been exposed to a taxane-containing chemotherapy in the mCRPC setting nor have received any prior PSMA-targeting radioligand therapy.

Mostra Descrizione Dettagliata

Categoria di Trattamento

Altri Farmaci, Radiofarmaci

Mutazioni richieste

Nessuno

Studio Iniziato

1 luglio 2025

Ultimo Aggiornamento dello Sponsor

24 febbraio 2026

Completamento Stimato

29 settembre 2028

Contatto dello studio

Nome:Novartis Pharmaceuticals

Email:novartis.email@novartis.com

Telefono:1-888-669-6682

Nome:Novartis Pharmaceuticals

Telefono:+41613241111

Idoneità

Criteri di Inclusione

* Signed informed consent must be obtained prior to participation in the study.

* Participants must be adults ≥ 18 years of age.

* Participants must have an ECOG performance status of 0 to 2.

* Participants must have histological, and/or cytological confirmation of adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are not eligible.

* Participants who have received taxane-based chemotherapy in mHSPC setting are eligible if they are deemed appropriate for chemotherapy, ARPI change or AAA617 as the next line of therapy in the opinion of the Investigator. Note: Participants who have received taxane-based chemotherapy for mCRPC are excluded.

* Participants must not have received taxane-based chemotherapy in mCRPC setting (allowed in mHSPC setting).

* Participants must have PSMA-PET positive disease using a PSMA imaging agent that is approved as per protocol.

* Participant must have been diagnosed with mCRPC with documented progressive disease while on treatment with ARPI in mHSPC or earlier setting as their last treatment (and did not progress on more than one ARPI).

* Participants with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer, as per local testing, may be enrolled if they had prior exposure to PARPi.

Criteri di Esclusione

* Previous anti-cancer treatment with any approved or investigational radiopharmaceuticals (for example, [177Lu]Lu-PSMA, [177Lu]-DOTA, or Radium- 223.)

* Previous treatment with any external beam radiotherapy including hemi-body radiation within 6 weeks of randomization (within 2 weeks for radiotherapy of localized metastases).

* Any prior PARP inhibitor or other systemic anticancer therapy administered for metastatic castration-resistant prostate cancer (mCRPC). Any other approved or investigational systemic therapy (including chemotherapy, immunotherapy, biologics, or monoclonal antibodies) is prohibited within 28 days or 5 half-lives (whichever is shorter) before randomization.

Note: Prior ARPI administered in the mHSPC setting or earlier may continue until C1D1.

Other protocol-defined inclusion/exclusion criteria may apply.

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Dettagli del Disegno

AllocazioneRandomized

Modello di InterventoParallel Assignment

MascheramentoNone (Open Label)

Numero da Arruolare940

Bracci e Interventi

Bracci

Interventi

Tipo: Experimental

Descrizione: Participants will receive AAA817 infusion directly into a vein with ARPIs.

Interventi:

AAA817
ARPI
Standard of Care

Misure di Esito

Misure di Esito Primarie

Radiographic Progression Free Survival (rPFS)From the date of randomization to the date of the first documented radiographic disease progression using conventional imaging, or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

Time to radiographic disease progression or death due to any cause.

Misure di Esito Secondarie

Overall Survival (OS) (Key Secondary Endpoint)From the date of randomization to the date of death due to any cause, assessed up to approximately 40 months.

Time to death due to any cause.

Progression Free Survival (PFS)From date of randomization to the first documented progression by investigator's assessment or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

Time to first documented progression or death due to any cause.

Progression Free Survival (PFS2)From date of randomization until date of second progression or date of death from any cause, whichever comes first, assessed up to approximately 40.0 months.

Time to first documented progression on next line of antineoplastic therapy or death from any cause.

Overall Response Rate (ORR)From the date of randomization to the date of the first documented radiographic disease progression, or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

The proportion of participants with best overall response (BOR) of confirmed complete response (CR) or partial response (PR) in soft tissue.

Disease Control Rate (DCR)From the date of randomization to the date of the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

The proportion of participants with BOR of confirmed CR, PR, stable disease (SD) or non-CR/non-progressive disease (PD) in soft tissue.

Duration of Response (DoR)From the date of first documented response (CR or PR) for confirmed responders and the date of first documented radiographic progression in soft tissue or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

Time between the date of first documented response and the date of first documented radiographic progression or death due to any cause.

Time to first radiographic soft tissue progression (TTSTP)From the date of randomization to the date of radiographic soft tissue progression or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

Time to radiographic soft tissue progression.

Time to first symptomatic skeletal event (TTSSE)From the date of randomization to the date of the first documented radiographic disease progression, or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

Time to date of first new symptomatic skeletal event of death due to any cause.

Prostate specific antigen response (PSA50 and PSA90)From the date of randomization to the date of safety follow up, assessed up to approximately 40.0 months.

The percentage of participants who achieved ≥ 50% and ≥ 90% decrease from baseline, respectively.

Time-concentration profiles and PK parameters of AAA817From Cycle 1 Day 1 up to approximately cycle 5 days 11 (each cycle is 8 weeks).

Time-concentration profiles and PK parameters of AAA817 (e.g. AUC, Cmax).

Change from baseline on FACT-P Prostate Cancer Subscale (PCS)From randomization to the first occurrence of worsening on the score or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

Change from baseline on FACT-P Prostate Cancer Subscale (PCS). FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment.

Time to worsening on the Worst PainFrom randomization to the first occurrence of worsening from baseline, or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

Time to worsening on the Worst Pain is defined as the time from randomization to the first occurrence of worsening on the Worst Pain item (BPI-SF) or death due to any cause, whichever occurs first.

rPFS in participants treated with AAA817From the date of randomization to the date of the first documented radiographic disease progression, or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

rPFS time to the date of first documented radiographic disease progression or death due to any cause, whichever occurs first.

Radiographic Progression Free Survival by by Prostate Cancer Working Group 3 (PCWG3)-modified RECIST v1.1 (Key Secondary)From date of randomization to the date of the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

Time to radiographic disease progression, using by blinded independent central review (BICR) using conventional imaging and Prostate Cancer Working Group 3 (PCWG3)-modified RECIST v1.1 criteria or death due to any cause.

Overall Survival in participants with PSMA-positive mCRPC treated with another ARPI. (Key Secondary)From the date of randomization to the date of death due to any cause.

Time to death due to any cause.

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Siti dello Studio

Questo studio ha 55 siti

Medical College of Wisconsin

Milwaukee, Wisconsin, US

Nome:Mariah Ziegler

Email:mziegler@mcw.edu

Telefono:414-805-5249

In fase di reclutamento

Milwaukee, Wisconsin, 53226 US

Medical College of Wisconsin

In fase di reclutamento

Denver, Colorado, 80218 US

Rocky Mountain Cancer Centers

In fase di reclutamento

Adelaide, South Australia, 5000 AU

Novartis Investigative Site

In fase di reclutamento

Sutton, Greater London, SM2 5PT GB

The Royal Marsden Hospital - Sutton

In fase di reclutamento

Guangzhou, 510060 CN

Novartis Investigative Site

In fase di reclutamento

Shanghai, 200032 CN

Novartis Investigative Site

In fase di reclutamento

Wuhan, Hubei, 430030 CN

Novartis Investigative Site

In fase di reclutamento

Hangzhou, Zhejiang, 310022 CN

Novartis Investigative Site

In fase di reclutamento

Beijing, 100036 CN

Novartis Investigative Site

In fase di reclutamento

Singapore, 119074 SG

Novartis Investigative Site

In fase di reclutamento

Santa Barbara, California, 93105 US

Sansum Clinic

In fase di reclutamento

Shanghai, 200025 CN

Novartis Investigative Site

In fase di reclutamento

Chengdu, Sichuan, 610041 CN

Novartis Investigative Site

In fase di reclutamento

Kaohsiung City, 83301 TW

Novartis Investigative Site

In fase di reclutamento

Wuhan, Hubei, 430022 CN

Novartis Investigative Site

In fase di reclutamento

Myrtle Beach, South Carolina, 29572 US

Carolina Urologic Research Center

In fase di reclutamento

Nanjing, Jiangsu, 210029 CN

Novartis Investigative Site

In fase di reclutamento

Darlinghurst, New South Wales, 2010 AU

Novartis Investigative Site

In fase di reclutamento

Cooperstown, New York, 13326 US

Bassett Medical Center

In fase di reclutamento

San Antonio, Texas, 78229 US

Urology San Antonio

In fase di reclutamento

Chiba, 260-8717 JP

Novartis Investigative Site

In fase di reclutamento

Kansas City, Kansas, 66160 US

University of Kansas Hospital

In fase di reclutamento

Beijing, 100034 CN

Novartis Investigative Site

In fase di reclutamento

Shanghai, 200127 CN

Novartis Investigative Site

In fase di reclutamento

Fukuoka, 812-0033 JP

Novartis Investigative Site

In fase di reclutamento

Orlando, Florida, 32804 US

AdventHealth

In fase di reclutamento

Shenyang, Liaoning, 110011 CN

Novartis Investigative Site

In fase di reclutamento

Singapore, 169608 SG

Novartis Investigative Site

In fase di reclutamento

Hong Kong, 999077 HK

Novartis Investigative Site

In fase di reclutamento

Nanjing, Jiangsu, 210006 CN

Novartis Investigative Site

In fase di reclutamento

Fukuoka, 811-0213 JP

Novartis Investigative Site

In fase di reclutamento

Seattle, Washington, 98122-4379 US

Swedish Medical Center

In fase di reclutamento

Singapore, 168583 SG

Novartis Investigative Site

In fase di reclutamento

New York, New York, 10021 US

Weill Cornell Medicine NY-Presb

In fase di reclutamento

Syracuse, New York, 13210 US

Associated Med Professionals of NY

In fase di reclutamento

Rochester, New York, 14642 US

University of Rochester Medical Ctr

In fase di reclutamento

Taoyuan District, 33305 TW

Novartis Investigative Site

In fase di reclutamento

São Paulo, São Paulo, 01308-050 BR

Novartis Investigative Site

In fase di reclutamento

São Paulo, São Paulo, 05652-000 BR

Novartis Investigative Site

In fase di reclutamento

St Louis, Missouri, 63110 US

Wash U School of Medicine

In fase di reclutamento

Seoul, 06351 KR

Novartis Investigative Site

In fase di reclutamento

Guangzhou, Guangdong, 510632 CN

Novartis Investigative Site

In fase di reclutamento

Seoul, Korea, 03080 KR

Novartis Investigative Site

In fase di reclutamento

Mumbai, Maharashtra, 400 012 IN

Novartis Investigative Site

In fase di reclutamento

Kobe, Hyōgo, 6500047 JP

Novartis Investigative Site

In fase di reclutamento

Yokohama, Kanagawa-ku, 236-0004 JP

Novartis Investigative Site

In fase di reclutamento

Fukuoka, 8128582 JP

Novartis Investigative Site

In fase di reclutamento

Hiroshima, 7348551 JP

Novartis Investigative Site

In fase di reclutamento

Miami, Florida, 33173 US

Miami Cancer Institute at Bapt

In fase di reclutamento

Iowa City, Iowa, 52242 US

Univ Of Iowa Hospitals And Clinics

In fase di reclutamento

Sapporo, Hokkaido, 0608648 JP

Novartis Investigative Site

In fase di reclutamento

Chuo Ku, Tokyo, 1040045 JP

Novartis Investigative Site

In fase di reclutamento

Kyoto, 6068507 JP

Novartis Investigative Site

In fase di reclutamento

Hong Kong, 999999 HK

Novartis Investigative Site

In fase di reclutamento

Gurgaon, Haryana, 122 002 IN

Novartis Investigative Site

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