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Highlights from the 2023 ASCO Genitourinary Cancers Symposium
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| NRG-GU011: A Phase II Double-Blinded, Placebo-Controlled Trial of Prostate Oligometastatic Radiotherapy with or Without Androgen Deprivation Therapy in Oligometastatic Prostate Cancer (NRG PROMETHEAN)
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| Bridget F. Koontz, MD
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| This study aims to evaluate the impact of relugolix, a novel oral gonadotropin-releasing hormone receptor antagonist, when combined with SABR to oligometastases. Dr. Koontz and colleagues also aim to determine adverse event rates for both treatment arms and evaluate genomic and blood markers of treatment response.
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| AlphaBet: A Phase I/II Trial Evaluating the Combination of Radium-223 and [177Lu]Lu-PSMA-I&T in Patients with mCRPC
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| Arun Azad, PhD, MBBS, FRACP
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| Arun Azad and colleagues hypothesize that combining a bone specific alpha emitter with LuPSMA will improve eradication of micrometastatic osseous disease, and thereby lead to higher and longer responses, while being safe and tolerable.
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| Efficacy and Safety of Darolutamide in Combination with ADT and Docetaxel by Disease Volume and Disease Risk in the Phase 3 ARASENS Study
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| Maha H. A. Hussain, MD, FACP, FASCO |
| Maha Hussain presented a post-hoc analysis of the ARASENS study reporting the impact of disease burden and risk on efficacy and safety outcomes. In patients with metastatic hormone-sensitive prostate cancer, the benefits of early treatment intensification with darolutamide + ADT + docetaxel on overall survival and key patient-relevant secondary efficacy endpoints vs placebo + ADT + docetaxel were similar in patients with high- and low-volume as well as high- and low-risk metastatic hormone-sensitive prostate cancer |
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| A Phase I/II Dose-Escalation Study of Fractionated 225Ac-J591 for Progressive mCRPC in Patients with Prior Treatment with 177Lu-PSMA |
| Jones T. Nauseef, MD, Ph.D.
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| With approval of 177Lu vipivotide tetraxetan, Jones Nauseef and colleagues amended an ongoing phase I dose-escalation study to include a post-177-Lu-PSMA cohort. The hypothesis is that a single fractionated dose-dense cycle of 225Ac-J591 will be safe when given to patients with prior 177Lu-PSMA radioligand therapy.
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| Darolutamide plus ADT Versus ADT in Metastatic Hormone-Sensitive Prostate Cancer: Open-Label Single-Arm Study with an External Control Arm (ARASEC)
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| Neal D. Shore, MD, FACS |
| ADT can be started ≤4 months before darolutamide, and there must be no evidence of progression on ADT before darolutamide initiation. The external control arm will be derived from 394 patients with metastatic hormone-sensitive prostate cancer treated with ADT alone in CHAARTED. |
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| Phase III Study of Local or Systemic Therapy Intensification Directed by PET in Prostate Cancer Patients with Post-Prostatectomy Biochemical Recurrence (INDICATE): ECOG-ACRIN EA8191
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| Neha Vapiwala, MD, FACR |
| Neha Vapiwala presented the framework for INDICATE, a phase III study of local or systemic therapy intensification directed by positron emission tomography (PET) in prostate cancer patients with post-prostatectomy biochemical recurrence.
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Poster Session A: Prostate Cancer
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| Effect of Equal Access to Care on Prostate Cancer Progression in Minority Patients
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| Kelli Rasmussen, MS
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| Kelli Rasmussen presented the results of their group’s study evaluating the association of race with progression from non-metastatic to metastatic castrate-resistant prostate cancer (mCRPC) within the context of the Veterans Affairs (VA) health care system.
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| Comparison of ctDNA Between African American and Caucasian Patients with CRPC Post Abiraterone And/or Enzalutamide
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| Albert Jang, MD
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| It is now widely appreciated that African American men experience higher incidence of and mortality from prostate cancer, yet the sources of these discrepancies are incompletely elucidated. Albert Jang and co-authors hypothesized that there are genetic differences between African American and Caucasian patients with advanced prostate cancer, which may contribute to differences in outcomes and survival. |
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| Impact of 68Ga-PSMA PET/CT in Patients with mCRPC Treated with Enzalutamide
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| Emilio Giunta, MD
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| The assessment of mCRPC by 68Ga-PSMA PET/CT before starting enzalutamide was associated with longer median progression-free survival and overall survival compared to prior studies using standard imaging only. Maximum standardized uptake volume and total lesion activity, expression of both volume and intensity of 68Ga-PSMA uptake, appeared the strongest parameter able to predict progression-free survival and overall survival.
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| 68GaPSMA-11 PET/CT to Monitor Treatment Response in Patients with Metastatic Prostate Cancer: The Concordance Between Biochemical Response and PSMA Response
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| Baris Esen, MD, PhD, FEBU, MSc
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| The aim of this study was to assess whether PSMA PET is associated with flares, with discordant results in regard to biochemical response, and with positivity rates at low PSA values while monitoring metastatic prostate cancer receiving systemic treatment.
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| Time Interval Between Radium‑223 (223Ra) Therapy and Lutetium-177–prostate-Specific Membrane Antigen (177Lu-PSMA) Treatment and Outcomes in the RALU Study |
| Kambiz Rahbar, MD
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| In data presented here, the authors evaluated the association of time interval between 223Ra and 177Lu-PSMA treatments and safety and OS outcomes of 177Lu-PSMA. These real-world data from the RALU study demonstrate that treating patients with 177Lu-PSMA within 6 months of completing 223Ra was clinically feasible and well tolerated, without differential survival outcomes.
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| Dosing, Safety, and Pharmacokinetics of Combination Therapy with Darolutamide, ADT, and Docetaxel in Patients with Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) in the ARASENS Study
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| Arash Rezazadeh, MD
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| The combination of darolutamide + docetaxel + ADT increases overall survival with similar overall incidence of treatment-emergent adverse events and no observed drug-drug interactions between darolutamide and docetaxel. Darolutamide can be effectively and safely administered with docetaxel in patients with mHSPC without clinically relevant changes in pharmacokinetics of darolutamide or docetaxel. |
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| Initial Results of a Phase 2 Pilot Study of Radium-223 and Radiotherapy in Untreated Hormone-Naïve Men with Oligometastatic Prostate Cancer to Bone
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| Jonathan Tward, MD, PhD
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| Jonathan Tward presented on a novel approach to treatment of patients with hormone-naïve, oligometastatic prostate cancer to bone with a combination of radium-223 and radiotherapy. First-line use of Ra223 and SBRT to oligometastatic disease sites in hormone-naïve men in this prospective pilot study resulted in a significant delay in ADT use compared to historical control, is well tolerated, and maintains QoL.
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| Circulating Tumor DNA Identifies Homologous Recombination Deficiency in Bone-Predominant mCRPC Prior to Radium-223 Therapy
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| David D. Yang, MD
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| David Yang and colleagues sought to evaluate circulating tumor DNA (ctDNA) for evidence of mutations in genes implicated in successful HR repair, thereby surmounting technical limitations of sequencing bone biopsies. They hypothesized that ctDNA would allow for broader identification of HRD in bone-predominant mCRPC and to assess association with clinical outcomes in a real-world cohort. |
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| Cost-Effectiveness Analysis of Seven Treatment Regimens in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC): A Public Payer Perspective Using Network Meta-Analysis |
| Manish Kohli, MD
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| Despite a number of available treatment options, there are no current predictive biomarkers to guide treatment selection. Thus, this paper aimed to determine the cost-effectiveness of each of the treatment approaches from the US public sector perspective with a lifetime horizon.
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| Development and Validation of a Multi-Institutional Nomogram of Outcomes for PSMA-PET–based Salvage Radiotherapy in Recurrent Prostate Cancer
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| Constantinos Zamboglou, MD
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| There have been numerous studies, including prospective registration data, demonstrating the effect of molecular imaging using PSMA-based PET/CT on patient management after BCR following radical prostatectomy. However, there are a lack of data to guide patient management. Thus, these authors aimed to develop and to validate a multi-institutional nomogram of outcomes for PSMA-PET based salvage radiotherapy following radical prostatectomy for patients with recurrent or persistent prostate cancer.
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Rapid Abstract Session: Prostate Cancer
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| Niraparib with Abiraterone Acetate and Prednisone in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Homologous Recombination Repair Gene Alterations: Second Interim Analysis of MAGNITUDE
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| Eleni Efstathiou, MD, PhD
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| It appears that patients with mCRPC harboring BRCA alterations have particularly poor outcomes with AAP alone, with a median rPFS of 10.9 months, relative to the historically observed rPFS of 16.5 months in an unselected population treated with AAP alone (COU-AA-302).
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Poster Session B: Prostate Cancer
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| Radium-223 for mCRPC, a Real-World Experience Study from 7 Galician Medical Centers
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| Urbano Herranz, MD
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| Radium-223 represents an option for symptomatic mCRPC after demonstrated an overall survival improvement in the ALSYMPCA trial. However, radium-223 real-life experiences are scarce, particularly after the results of the ERA-223 trial. The objective of this study was to describe radium-223 outcomes in real life practice, and specifically those related with bone health, sequence of treatment, and prognostic factors.
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