Abstract 2944
Background
The addition of docetaxel (Dx) to androgen deprivation therapy (ADT), as first-line in patients (pt) with high-volume metastatic hormone-sensitive prostate cancer (hvHSPC) has demonstrated to increase time to biochemical, radiographic and clinical progression (bPFS, rPFS, cPFS), as well as overall survival (OS) in two different trials. We hypothesized that early addition of immunotherapy (I/O) or other new drugs to ADT+Dx could improve outcomes. A MAMS has been designed to optimize resources and recruitment, by concurrently comparing different new strategies, and selecting the most effective(s) for a final phase III trial.
Trial design
PROSTRATEGY is a randomized MAMS trial in pt with hvHSPC, comparing ADT+Dx (control arm: ADT + 6 cycles of Dx 75 mg/m2 + GCSF), to ADT+DX+Nivo (ADT+Dx followed by Nivolumab 3 mg/Kg/2w x 12 mo), or ADT+Ipi+Dx+Nivo (ADT + 2 cycles of Ipilimumab 3 mg/Kg/3w, followed by 3 cycles of Dx + GCSF, 2 cycles of Ipilimumab, 3 cycles of Dx + GCSF, and then Nivolumab 3 mg/Kg/2w x 12 mo). Randomization rate (ADT+Dx/experimental arms) is 2/1. The design allows that additional experimental arms with ADT+DX + other potential active drugs could also be incorporated in the future to the study. According to a priori established criteria based on cPFS, those arms considered not sufficiently effective at any of the 3 planned intermediate stages, will be closed. Those arms that meet the intermediate endpoints will remain in the study, and will be compared to ADT-DX in a seamless phase III trial, with OS (HR = 0.75) as a primary end-point. The pilot phase with the first 120 pt of the first stage of the trial has been started in 30 centres in Spain funded by Bristol-Myers Squibb. The aim is to assess safety of I/O arms, and to estimate and compare outcomes based on RECIST, iRECIST and PCWG3 criteria of efficacy. Collaboration with other cooperative groups is also planned after the pilot phase.
Clinical trial identification
2017-004377-13.
Editorial acknowledgement
Legal entity responsible for the study
SOGUG: Spanish Oncology Genito-Urinary Group.
Funding
Bristol-Myers Squibb.
Disclosure
J.A. Arranz Arija: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Novartis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: MSD Oncology; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Janssen-Cilag; Honoraria (self), Advisory / Consultancy: EUSA Pharma; Honoraria (self), Advisory / Consultancy: Astellas-Pharma; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Bristol-Myers-Squibb; Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Advisory / Consultancy: Bayer; Advisory / Consultancy: Ipsen; Research grant / Funding (institution): Pierre-Fabre. B. P. Valderrama: Honoraria (self), Advisory / Consultancy: Pierre-Fabre; Honoraria (self), Advisory / Consultancy: Astellas Pharma; Honoraria (self): Novartis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Bristol-Myers-Squibb; Honoraria (self), Advisory / Consultancy: Ipsen; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy: Bayer; Advisory / Consultancy: Sanofi-Aventis; Advisory / Consultancy: MSD Oncology; Travel / Accommodation / Expenses: Janssen-Cilag; Travel / Accommodation / Expenses: Pfizer; Advisory / Consultancy: EUSA Pharma. T. Alonso Gordoa: Advisory / Consultancy: Bristol-Myers-Squibb; Advisory / Consultancy: MSD Oncology; Advisory / Consultancy, Research grant / Funding (self): Roche; Advisory / Consultancy, Speaker Bureau / Expert testimony: Astellas Pharma; Advisory / Consultancy, Speaker Bureau / Expert testimony: Ipsen; Advisory / Consultancy, Travel / Accommodation / Expenses: Sanofi-Aventis; Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Pfizer; Speaker Bureau / Expert testimony: Janssen-Cilag; Speaker Bureau / Expert testimony: Novartis. E. Gallardo Diaz: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Sanofi; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Janssen-Cilag; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Astellas Pharma; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Bayer; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Ipsen; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Eisai; Advisory / Consultancy: EUSA Pharma; Honoraria (self), Advisory / Consultancy: Bristol-Myers-Squibb; Honoraria (self), Advisory / Consultancy: Rovi; Honoraria (self), Advisory / Consultancy: Daiichi; Honoraria (self), Advisory / Consultancy: Sankyo; Advisory / Consultancy: Techdow; Honoraria (self): Leo Pharma; Honoraria (self): Menarini; Travel / Accommodation / Expenses: Pierre-Fabre; Travel / Accommodation / Expenses: Ferrer; Travel / Accommodation / Expenses: GSK. J.M. Sepulveda Sanchez: Advisory / Consultancy, Travel / Accommodation / Expenses: AbbVie; Advisory / Consultancy, Travel / Accommodation / Expenses: Celgene; Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Catalysis; Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Astellas Pharma; Travel / Accommodation / Expenses: Ipsen. J.M. Piulats: Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: Bristol-Myers-Squibb; Advisory / Consultancy, Research grant / Funding (self): MSD Oncology; Advisory / Consultancy, Research grant / Funding (self): Merck-Serono; Advisory / Consultancy: Novartis; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Janssen-Cilag; Advisory / Consultancy: Clovis; Advisory / Consultancy, Travel / Accommodation / Expenses: Astellas Pharma; Advisory / Consultancy: Roche; Advisory / Consultancy: BeiGene; Advisory / Consultancy: VCN Bioscience; Travel / Accommodation / Expenses: Ipsen; Research grant / Funding (institution): Pfizer; Research grant / Funding (self): Incyte. M.J. Mendez Vidal: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Janssen-Cilag; Honoraria (self), Advisory / Consultancy: Bayer Healthcare; Honoraria (self), Advisory / Consultancy: Sanofi-Aventis; Honoraria (self), Advisory / Consultancy: Astellas Pharma; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Bristol-Myers-Squibb; Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer. N. Sala González: Advisory / Consultancy: Pfizer; Advisory / Consultancy: Sanofi. S. Vazquez Estevez: Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy: Astellas Pharma; Advisory / Consultancy: Janssen-Cilag; Advisory / Consultancy: MSD Oncology; Honoraria (self), Advisory / Consultancy: Bayer; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy: Bristol-Myers-Squibb; Honoraria (self), Advisory / Consultancy: Boehringer; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Advisory / Consultancy: Ipsen; Honoraria (self), Advisory / Consultancy: Novartis; Advisory / Consultancy: EUSA Pharma; Advisory / Consultancy: Eisai; Honoraria (institution), Advisory / Consultancy: Sanofi-Aventis; Honoraria (self): Lilly. M. Lázaro Quintela: Advisory / Consultancy: Bristol-Myers-Squibb; Advisory / Consultancy, Travel / Accommodation / Expenses: MSD Oncology; Advisory / Consultancy: Takeda; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Ipsen; Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Boehringer Ingelheim; Advisory / Consultancy, Travel / Accommodation / Expenses: Pierre-Fabre; Advisory / Consultancy: Bayer; Honoraria (self): Lilly; Honoraria (self), Travel / Accommodation / Expenses: Astellas Pharma; Honoraria (self), Travel / Accommodation / Expenses: Janssen-Cilag; Honoraria (self): Novartis; Honoraria (self): Vifor. M.A. Climent Duran: Honoraria (self), Advisory / Consultancy: Bristol-Myers-Squibb; Honoraria (self), Travel / Accommodation / Expenses: Astellas Pharma; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Janssen-Cilag; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: MSD Oncology; Honoraria (self): Sanofi-Aventis; Honoraria (self), Advisory / Consultancy: Bayer; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy: Pfizer; Honoraria (self): Novartis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Ipsen; Advisory / Consultancy: EUSA Pharma; Advisory / Consultancy: Pierre-Fabre. J. Puente: Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Sanofi-Aventis; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Janssen-Cilag; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Astellas Pharma; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Pfizer; Advisory / Consultancy, Speaker Bureau / Expert testimony: Bayer; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Ipsen; Advisory / Consultancy: Novartis; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Eisai; Advisory / Consultancy: EUSA Pharma; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Bristol-Myers-Squibb; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: MSD Oncology; Travel / Accommodation / Expenses: Pierre-Fabre. J. García Sánchez: Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche; Speaker Bureau / Expert testimony: Boehringer Ingelheim; Advisory / Consultancy: EUSA Pharma; Travel / Accommodation / Expenses: Bristol-Myers-Squibb; Travel / Accommodation / Expenses: MSD Oncology; Travel / Accommodation / Expenses: Pfizer. J. Carles: Research grant / Funding (institution): AB Science; Research grant / Funding (institution): Aragon Pharmaceuticals; Research grant / Funding (institution): Arog Pharmaceuticals, Inc.; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Astellas Pharma; Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca AB; Research grant / Funding (institution): Aveo Pharmaceuticals, Inc.; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Bayer AG; Research grant / Funding (institution): Blueprint Medicines Corporation; Research grant / Funding (institution): BN Immunotherapeuticals, Inc.; Research grant / Funding (institution): Boehringer Ingelheim España SA; Research grant / Funding (institution): Bristol-Myers-Squibb International Corporation; Research grant / Funding (institution): Clovis Oncology, Inc.; Research grant / Funding (institution): Cougar Biotechnology, Inc.; Research grant / Funding (institution): Deciphera Pharmaceuticals LLC; Research grant / Funding (institution): Exerelixis Inc.; Research grant / Funding (institution): F. Hoffmann-La Roche Ltd.; Research grant / Funding (institution): Genentech, INC; Research grant / Funding (institution): GlaxoSmithKline SA; Research grant / Funding (institution): Incyte Corporation; Research grant / Funding (institution): Janssen-Cilag International NV; Research grant / Funding (institution): Karyopharm Therapeutics Inc.; Research grant / Funding (institution): Laboratoires Leurquin Mediolanum SAS; Research grant / Funding (institution): Lilly SA; Research grant / Funding (institution): Medimmune; Travel / Accommodation / Expenses: Millennium Pharmaceuticals Inc.; Research grant / Funding (institution): Nanobiotix S.A.; Research grant / Funding (institution): Novartis Pharmaceutical SA; Research grant / Funding (institution): Pfizer SLU; Research grant / Funding (self): Puma Biotechnology, Inc.; Advisory / Consultancy, Research grant / Funding (institution): Sanofi-Aventis S.A.; Speaker Bureau / Expert testimony: SFJ Pharma Ltd.II; Research grant / Funding (institution): Teva Pharma SLU; Advisory / Consultancy: Bristol-Myers-Squibb; Advisory / Consultancy, Speaker Bureau / Expert testimony: Johnson and Johnson; Advisory / Consultancy: Pfizer; Advisory / Consultancy: MSD Oncology; Advisory / Consultancy: Roche; Speaker Bureau / Expert testimony: Asofarma. All other authors have declared no conflicts of interest.
Resources from the same session
1500 - Retrospective evaluation of neutropenic admission events in metastatic or high-risk hormone-sensitive prostate cancer (HSPC) patients having docetaxel chemotherapy upfront or for castrate-resistant prostate cancer (CRPC) in STAMPEDE
Presenter: Harriet Mintz
Session: Poster Display session 3
Resources:
Abstract
3524 - Cabazitaxel For Octogenarian Patients With Metastatic Castration-Resistant Prostate Cancer (MCRPC).
Presenter: Paolo Tralongo
Session: Poster Display session 3
Resources:
Abstract
5637 - External Validation of a Prognostic Score in First-Line Metastastic Castration-Resistant Prostate Cancer (mCRPC)
Presenter: David Lorente
Session: Poster Display session 3
Resources:
Abstract
3228 - Treatment outcomes of 3rd treatment in a real-world metastatic castration resistant prostate cancer (mCRPC) population: results from the Dutch CAPRI-registry
Presenter: Jessica Notohardjo
Session: Poster Display session 3
Resources:
Abstract
4695 - Pelvic lymph node dissection and its extent on survival benefit in prostate cancer patients with a risk of lymph node invasion>5%: a propensity score matching analysis from SEER database
Presenter: Junru Chen
Session: Poster Display session 3
Resources:
Abstract
4438 - Multi-institutional evaluation of therapeutic management for oligometastatic cancer prostate recurrence with choline-PET/CT
Presenter: Morgane Guibert-broudic
Session: Poster Display session 3
Resources:
Abstract
4574 - Safety of new androgen receptor inhibitors (ARi) in patients with nonmetastatic castration-resistant prostate cancer (nmCRPC): a network meta-analysis of randomized controlled trials (RCT)
Presenter: Amelia Altavilla
Session: Poster Display session 3
Resources:
Abstract
3816 - Real-world use of radium-223 for treatment of metastatic castration resistant-prostate cancer (mCRPC): results from the Dutch CAPRI registry
Presenter: Malou Kuppen
Session: Poster Display session 3
Resources:
Abstract
5180 - A phase 2a study of radium-223 dichloride (Ra-223) alone or in combination with abiraterone acetate or enzalutamide in metastatic castration-resistant prostate cancer (mCRPC)
Presenter: Daniel Petrylak
Session: Poster Display session 3
Resources:
Abstract
1067 - Adding ADT to PSMA-PET/CT-guided SBRT for oligometastatic prostate cancer improves distant progression-free survival
Presenter: Carole Mercier
Session: Poster Display session 3
Resources:
Abstract