A clinical trial to learn more about the effects of AAA817 given with an androgen receptor pathway inhibitor (ARPI) in men with prostate cancer
Key facts
- Where
- Bologna, Meldola, Milan, Pisa és Rozzano, OlaszországSee the 5 sites
- Phase
- 3. fázis
Where in Olaszország
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, OlaszországToborzás még nem indult
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.lMeldola, OlaszországToborzás még nem indult
- Istituto Europeo di Oncologia s.r.lMilan, OlaszországToborzás még nem indult
- Azienda Ospedaliero Universitaria PisanaPisa, OlaszországToborzás még nem indult
- Humanitas Mirasole S.p.A.Rozzano, OlaszországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novartis Pharma AG
- Trial code
- EU 2024-512340-32-01
- Record updated
- 2026. november 10.
- Original description
To determine whether treatment with AAA817+ARPI change prolongs radiographic progression free survival (rPFS) XX in participants with PSMA-positive mCRPC, treated with another ARPI as last treatment as compared to participants treated with investigator’s choice of standard of care (SoC).Read full original descriptionShow less
AcTFirst: A phase III, open-label, multi-center, randomized study comparing AAA817+ARPI versus standard of care in adult participants with PSMA-positive metastatic castration resistant prostate cancer
To determine whether treatment with AAA817+ARPI change prolongs radiographic progression free survival (rPFS) XX in participants with PSMA-positive mCRPC, treated with another ARPI as last treatment as compared to participants treated with investigator’s choice of standard of care (SoC).
Inclusion: 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 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. Note: A participant’s candidacy for PARPi is per the investigator’s discretion; 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 the mHSPC setting are eligible if they are deemed appropriate for chemotherapy or 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 have PSMA-PET positive disease using a PSMA imaging agent allowed as per protocol and are eligible XX; 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), based on at least 1 of the following criteria: . Serum/plasma PSA progression is defined as 2 increases in PSA measured at least 1 week apart. The minimal start value is 2.0 ng/mL; 1.0 ng/mL is the minimal starting value if confirmed rise in PSA is the only indication of progression as per PCWG3 guidelines. . . Progression of bone disease: 2 new lesions; only positivity on the bone scan defines metastatic disease to bone XX.
Exclusion: 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 XX weeks of randomization (within XXweeks for radiotherapy of localized metastases); Any approved or investigational agents/systemic anti-cancer therapy (e.g. other concurrent chemotherapy, investigational therapy, immunotherapy or biological therapy including monoclonal antibodies) within XX days (or 5 times the half-life of that therapy whichever is shorter) prior to the day of randomization. Note: Prior ARPIs are allowed to continue until first dose of study treatment (C1D1) is initiated.