Age: 18+
Sex: Male
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Novartis Pharmaceuticals
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial is testing a new oral drug called ARV-766, alone or with abiraterone, in men with advanced prostate cancer that has spread. The drug works by blocking proteins that help cancer cells grow. Abiraterone is a well-established drug used in the treatment of metastatic castration-resistant prostate cancer, often in combination with other therapies.
Is the drug ARV-766 (Luxdegalutamide) a promising treatment for prostate cancer?Yes, ARV-766 (Luxdegalutamide) is a promising drug for prostate cancer because it is being studied in combination with abiraterone, which is already known to help patients with advanced prostate cancer live longer and manage their symptoms.134910
Do I need to stop taking my current medications to join the trial?The trial requires stopping systemic anti-cancer therapy 2 weeks before starting the study drug, except for medications to maintain castrate status. If you're taking bicalutamide, mitomycin C, or nitrosoureas, you need a 6-week break, and for abiraterone, a 4-week break is required.
What safety data is available for ARV-766 and Abiraterone in prostate cancer treatment?The provided research does not directly mention ARV-766 or Luxdegalutamide, but it does discuss the safety and adverse effects of Abiraterone, which is part of the trial. Abiraterone has been associated with cardiovascular toxicity and adverse events related to its plasma levels. The studies highlight the need to monitor cardiovascular health in patients receiving Abiraterone.6781113
What data supports the idea that ARV-766 +/- Abiraterone for Prostate Cancer is an effective treatment?The available research shows that combining abiraterone with other treatments like enzalutamide can improve outcomes for patients with prostate cancer. For example, one study found that adding abiraterone to enzalutamide may help patients live longer. Another study indicated that abiraterone is particularly effective for African American men, helping them live longer without the cancer getting worse. These findings suggest that abiraterone, when used with other treatments, can be an effective option for prostate cancer.25121415
Eligibility Criteria
Men with metastatic prostate cancer who've had progression after at least two systemic therapies, including a second-generation androgen inhibitor. They must have an ECOG performance status of 0 or 1, be on ADT, and can't have had more than two chemo regimens. Exclusions include recent anti-cancer therapy, certain gastrointestinal conditions, symptomatic brain metastases requiring steroids, recent radiation therapy or investigational drugs.Inclusion Criteria
I am currently on hormone therapy for cancer or have had an orchiectomy.
My prostate cancer has worsened despite two prior treatments, including a modern hormone therapy.
I have taken 1-3 types of specific prostate cancer drugs and no more than 2 chemotherapy treatments for my advanced prostate cancer.
I am fully active or restricted in physically strenuous activity but can do light work.
My prostate cancer has been confirmed by a lab test.
Exclusion Criteria
Part A and B: Known symptomatic brain metastases requiring steroids (above physiologic replacement doses). Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease, or previous gastric resection or lap band surgery. Radiation therapy within 4 weeks of first dose of study drug or prior irradiation to >25% of the bone marrow. Receipt of an investigational drug(s) within 4 weeks prior to anticipated first dose. Systemic anti-cancer therapy within 2 weeks of first dose of study drug (except agents to maintain castrate status). For bicalutamide, mitomycin C, or nitrosoureas the exclusion period must be 6 weeks and for abiraterone 4 weeks.
Treatment Details
The trial is testing ARV-766 alone (Part A&B) and in combination with abiraterone (Part C&D), taken orally for men with advanced prostate cancer. It's to see how safe they are and how well they work as treatments.
2Treatment groups
Experimental Treatment
Group I: ARV-766 + AbirateroneExperimental Treatment1 Intervention
Oral tablets, once daily in 28 day cycles
Group II: ARV-766Experimental Treatment1 Intervention
Oral tablets, once daily in 28 day cycles
Find a clinic near you
Research locations nearbySelect from list below to view details:
Clinical Trial SiteOrange, CA
Clinical Trial SiteChicago, IL
Clinical Trial SiteNew Haven, CT
Clinical Trial SiteMyrtle Beach, SC
More Trial Locations
Loading ...
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
Arvinas Androgen Receptor, Inc.Lead Sponsor
References
Retreatment of men with metastatic castrate-resistant prostate cancer with abiraterone. [2016]Abiraterone acetate (AA), oral CYP17 inhibitor, is an active agent in the treatment of metastatic castrate-resistant prostate cancer (mCRPC).
Androgen receptor expression in circulating tumour cells from castration-resistant prostate cancer patients treated with novel endocrine agents. [2022]Abiraterone and enzalutamide are novel endocrine treatments that abrogate androgen receptor (AR) signalling in castration-resistant prostate cancer (CRPC). Here, we developed a circulating tumour cells (CTCs)-based assay to evaluate AR expression in real-time in CRPC and investigated nuclear AR expression in CTCs in patients treated with enzalutamide and abiraterone.
Low Incidence of Corticosteroid-associated Adverse Events on Long-term Exposure to Low-dose Prednisone Given with Abiraterone Acetate to Patients with Metastatic Castration-resistant Prostate Cancer. [2022]Abiraterone acetate (AA) is the prodrug of abiraterone, which inhibits CYP17A1 and testosterone synthesis and prolongs the survival of patients with metastatic castration-resistant prostate cancer (mCRPC). AA plus prednisone (P) (AA+P) is approved for the treatment of patients with mCRPC.
Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer. [2022]Abiraterone acetate, a drug that blocks endogenous androgen synthesis, plus prednisone is indicated for metastatic castration-resistant prostate cancer. We evaluated the clinical benefit of abiraterone acetate plus prednisone with androgen-deprivation therapy in patients with newly diagnosed, metastatic, castration-sensitive prostate cancer.
Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy. [2023]Abiraterone acetate plus prednisolone improves survival in men with relapsed prostate cancer. We assessed the effect of this combination in men starting long-term androgen-deprivation therapy (ADT), using a multigroup, multistage trial design.
Novel Junction-specific and Quantifiable In Situ Detection of AR-V7 and its Clinical Correlates in Metastatic Castration-resistant Prostate Cancer. [2023]Androgen receptor splice variant 7 (AR-V7) has been implicated in resistance to abiraterone and enzalutamide treatment in men with metastatic castration-resistant prostate cancer (mCRPC). Tissue- or cell-based in situ detection of AR-V7, however, has been limited by lack of specificity.
The Cardiovascular Toxicity of Abiraterone and Enzalutamide in Prostate Cancer. [2021]The cardiovascular toxicity related to abiraterone and enzalutamide has been previously studied by our group. In this analysis, we aim to update our previous findings related to abiraterone and enzalutamide, including the new available evidence, both in castration-resistant and hormone-sensitive prostate cancer. PATIENTS AND METHODS: Prospective studies were identified by searching the MEDLINE/PubMed, Cochrane Library, and ASCO Meeting abstracts. Combined relative risks (RRs) and 95% confidence intervals (CIs) were calculated using fixed- or random-effects methods.
Managing lines of therapy in castration-resistant prostate cancer: real-life snapshot from a multicenter cohort. [2021]To provide a snapshot of toxicities and oncologic outcomes of Abiraterone (AA) and Enzalutamide (EZ) in a chemo-naïve metastatic castration-resistant prostate cancer (mCPRC) population from a longitudinal real-life multicenter cohort.
Abiraterone experience in a patient with metastatic castration-resistant prostate cancer on hemodialysis. [2020]Abiraterone is an oral inhibitor of cytochrome P450 (17alpha)-hydroxylase/17,20 lyase (CYP17) complex critical to androgen production. Abiraterone in combination with prednisone is currently FDA approved for use in men with metastatic castration-resistant prostate cancer, both in the pre- and post-chemotherapy settings. This article discusses the treatment with abiraterone in a patient with metastatic castration-resistant prostate cancer on hemodialysis.
[Early- vs. late-onset treatment using abiraterone acetate plus prednisone in chemo-naïve, asymptomatic or mildly symptomatic patients with metastatic CRPC after androgen deprivation therapy]. [2022]Abiraterone acetate (AA) is a prodrug of abiraterone, which is an irreversible inhibitor of 17α-hydroxylase/C17, 20-lyase. Since 2011, abiraterone acetate has been available in combination with prednisone/prednisolone (AA + P) for the treatment of metastatic castration-resistant prostate cancer (mCRPC) after pre-treatment with docetaxel, and since 2012 for the treatment of chemotherapy-naïve asymptomatic or mildly symptomatic mCRPC patients. A revision of the guidelines of the European Association of Urology in 2014 redefining castration resistance gave rise to the question of when the treatment of mCRPC with abiraterone acetate plus prednisone should be initiated after prior hormone treatment and how successful it would be. This led us to observe an early-onset AA + P therapy cohort (EC) and a late-onset therapy cohort (LC) of patients.
Abiraterone and enzalutamide had different adverse effects on the cardiovascular system: a systematic review with pairwise and network meta-analyses. [2022]Abiraterone and enzalutamide may increase the risk of cardiovascular events in patients with castration-resistant prostate cancer (CRPC).
Outcomes Among African American and Non-Hispanic White Men With Metastatic Castration-Resistant Prostate Cancer With First-Line Abiraterone. [2022]Prospective evidence suggests abiraterone is associated with superior progression-free survival for African American men compared with non-Hispanic White men with metastatic castration-resistant prostate cancer (mCRPC).
Impact of trough abiraterone level on adverse events in patients with prostate cancer treated with abiraterone acetate. [2023]We assessed the impact of plasma trough concentrations of abiraterone (ABI) and its metabolite Δ4-abiraterone (D4A) and related polymorphisms on adverse events (AEs) in patients with metastatic prostate cancer who received abiraterone acetate (AA).
Randomized Phase III Study of Enzalutamide Compared With Enzalutamide Plus Abiraterone for Metastatic Castration-Resistant Prostate Cancer (Alliance A031201 Trial). [2023]Enzalutamide and abiraterone both target androgen receptor signaling but via different mechanisms. The mechanism of action of one drug may counteract the resistance pathways of the other. We sought to determine whether the addition of abiraterone acetate and prednisone (AAP) to enzalutamide prolongs overall survival (OS) in patients with metastatic castration-resistant prostate cancer (mCRPC) in the first-line setting.
Abiraterone acetate plus prednisolone with or without enzalutamide for patients with metastatic prostate cancer starting androgen deprivation therapy: final results from two randomised phase 3 trials of the STAMPEDE platform protocol. [2023]Abiraterone acetate plus prednisolone (herein referred to as abiraterone) or enzalutamide added at the start of androgen deprivation therapy improves outcomes for patients with metastatic prostate cancer. Here, we aimed to evaluate long-term outcomes and test whether combining enzalutamide with abiraterone and androgen deprivation therapy improves survival.