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Highlights from the 2023 American Society of Clinical Oncology Annual Meeting
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| Building a Predictive Model for Outcomes with 177Lu-PSMA-617 in Patients with mCRPC Using VISION Data: Preliminary Results
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| Ken Herrmann, MD |
| Ken Herrmann presents the preliminary results of building a predictive model for outcomes with 177Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer using VISION data. Bayesian modeling identified parameters that could be combined into a multivariate model to predict outcomes in patients treated with 177Lu-PSMA-617 + standard of care in VISION with good performance. |
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| Darolutamide Observational (DAROL) Study in Patients with Nonmetastatic Castration-Resistant Prostate Cancer: Second Interim Analysis
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| Evan Yu, MD
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| Evan Yu presents the 2nd interim results of DAROL, an observation study evaluating darolutamide use in patients with non-metastatic castration-resistant prostate cancer. In the DAROL second interim analysis report, under real-world conditions, darolutamide continued to show a favorable safety profile, consistent with the clinical profile observed in ARAMIS, with no new safety signals.
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| Effects of 177Lu-PSMA-617 on Overall Survival in TheraP versus VISION Randomized Trials: An Exploratory Analysis
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| Yu Yang Soon, MD
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| Yu Yang Soon discussed an exploratory analysis of the effects of 177Lu-PSMA-617 (LuPSMA) on overall survival in TheraP versus VISION randomized trials. LuPSMA in metastatic castration resistant prostate cancer was evaluated in the VISION and TheraP randomized trials and reported remarkably different effects on overall survival.
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| Depth of PSA Nadir and Subsequent PSA Progression-Free Survival in Patients with High-Risk Biochemically Relapsed Prostate Cancer: Results from the Phase 3 PRESTO Study (AFT-19) |
| Rahul Raj Aggarwal, MD |
| Failure to reach a PSA nadir less than 0.1 ng/mL within three months of ADT initiation in biochemically recurrent prostate cancer is associated with shorter time to subsequent progression following treatment discontinuation. Follow-up is ongoing to integrate genomic profiling of primary prostate cancer tissues and whole blood RNA in patients with suboptimal PSA nadir to identify potential markers of relative androgen pathway inhibitor resistance. |
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| Assessing Racial Differences in Time to Treatment Escalation Following Androgen-Deprivation Therapy Among Veterans with Prostate Cancer |
| Nadine Friedrich, MD
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Nadine Friedrich presents the results of an analysis evaluating racial differences in time to treatment escalation following ADT among veterans with prostate cancer. This study assessing racial differences in time to treatment escalation of men receiving 1st line ADT found that African Americans had significantly lower rates of treatment escalation. Whether this decreased rate of treatment escalation represents improved outcomes (i.e., lower rates of progression) or undertreatment requires further study.
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| Landscape and Impact of Germline Pathogenic Variants in Metastatic Hormone Sensitive Prostate Cancer: Ancillary Study of E3805 CHAARTED
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| Anis Hamid, MBBS
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| Anis Hamid presents the results of an ancillary analysis of CHAARTED, evaluating the landscape and impact of germline pathogenic variants in metastatic hormone sensitive prostate cancer. In this analysis, the investigators performed whole exome sequencing of germline DNA derived from whole blood available from patients in the phase III CHAARTED trial of androgen deprivation therapy versus ADT plus docetaxel.
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| CABIOS Trial: A Phase Ib Study of Cabozantinib and Nivolumab in Combination with Abiraterone in Patients with Metastatic Hormone Sensitive Prostate Cancer |
| Jesse Meir Zaretsky, MD, Ph.D. |
| Jesse Zaretsky presented the results of CABIOS, a phase Ib study of cabozantinib and nivolumab in combination with abiraterone in patients with metastatic hormone sensitive prostate cancer (mHSPC). CABIOS is the first trial evaluating the combination of cabozantinib and nivolumab in mHSPC patients receiving abiraterone. This combination appears to have a safety profile consistent with known adverse events for these agents, no dose-limiting toxicities, and evidence of clinical benefit. |
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| Basal-Luminal Subtyping of Localized High-Risk Prostate Cancer and Benefit of Adding Docetaxel to Definitive Radiotherapy with Androgen Suppression in the NRG Oncology/RTOG 0521 Phase III Trial |
| Ryan Phillips, MD, PhD
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| Ryan Phillips presents an analysis of the NRG Oncology/RTOG 0521 phase III trial evaluating the benefit of adding docetaxel to definitive radiotherapy based on basal-luminal subtyping of localized, high-risk prostate cancer patients. Luminal-basal subtyping of prostate cancer tissue, using pre-treatment biopsy samples from a Phase 3 trial cohort of localized high-risk men, demonstrated differential responses to docetaxel chemotherapy.
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| Post Radical Prostatectomy PSA Outcomes Following 6 vs 18 Months of Perioperative Androgen Deprivation Therapy in Men with Localized High Risk Prostate Cancer: Results of Part 2 of a Randomized Phase 2 Trial
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| Rana McKay, MD
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| Rana McKay presented the results of a phase II trial evaluating post-radical prostatectomy PSA outcomes following 6 versus 18 months of perioperative ADT in men with localized, high-risk prostate cancer. Dr. McKay concluded that neoadjuvant ADT in localized, high-risk prostate cancer resulted in favorable pathologic responses and 3-year bPFS in a subset of patients. As 30% of patients declined an additional 12 months of adjuvant treatment, the study was underpowered to detect a difference between 6 versus 18 months of treatment. |
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| Testosterone Recovery Following Androgen Suppression and Prostate Radiotherapy: Updated Individual Patient Data Meta-Analyses from the MARCAP Consortium |
| Wee Loon Ong, MBBS |
| Wee Loon Ong presents the results of TRANSPORT, evaluating testosterone recovery following androgen suppression and prostate radiotherapy, using updated individual patient data meta-analyses from the MARCAP consortium. This is the largest pooled analysis of prospectively collected serial testosterone data from randomized trials, indicating substantial delay in full testosterone recovery in men receiving longer durations of ADT. |
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| GUIDE: A Randomized Non-Comparative Phase II Trial of Biomarker-Driven Intermittent Docetaxel Versus Standard-of-Care Docetaxel in Metastatic Castration-Resistant Prostate Cancer (ANZUP 1903) |
| Ciara Conduit, MBBS, FRACP
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| GUIDE is the first study to prospectively evaluate the clinical utility of a circulating epigenetic biomarker (mGSTP1) for the selection of treatment de-intensification in prostate cancer, building upon existing data supporting its analytical and clinical validity. They anticipate that mGSTP1 will allow for the safe selection of patients eligible for treatment de-intensification and thus improve quality of life outcomes for mCRPC patients. |
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| A Phase 1/2 Study of Combination Olaparib and Radium-223 in Men with Metastatic Castration-Resistant Prostate Cancer with Bone Metastases (COMRADE): A Trial in Progress |
| Chinmay Jani, MBBS |
| Chinmay Jani presents an update on COMRADE, a phase 1/2 study evaluating the combination of olaparib and Radium-223 in mCRPC patients with bone metastases. Exploratory endpoints will include whole exome and tissue sequencing of baseline biopsy tissue, assessment of RAD51 IHC and correlation with outcomes, ctDNA assessment and correlation with responses, evaluation of changes in the tumor immune microenvironment, and quality of life assessment. |
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