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| Advances in mCRPC Management: Recent Approvals, Emerging Therapies, and Future Directions: A Letter from UroToday's mCRPC Center of Excellence Editor-in-Chief
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| A. Oliver Sartor, MD
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| Dr. A. Oliver Sartor highlights significant progress in mCRPC treatment, including recent FDA approvals and emerging therapies. Key advancements include 177Lu-PSMA-617, which demonstrated survival benefits in pre- and post-taxane settings, and PARP inhibitor combinations like olaparib and talazoparib for HRR-mutated mCRPC. Investigational therapies such as bispecific antibodies, novel radiopharmaceuticals, and metastases-directed treatments like SBRT offer promising new directions, with ongoing trials further shaping future management strategies.
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PEER-TO-PEER CLINICAL CONVERSATIONS |
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| PSMAfore Trial: Lutetium PSMA's Impact on mCRPC Quality of Life |
| Karim Fizazi, MD, PhD |
| Alicia Morgans interviews Karim Fizazi about the updated survival and quality of life data from the PSMAfore trial. The study compares lutetium PSMA to second-line AR pathway inhibitors in metastatic castration-resistant prostate cancer patients who have progressed after one AR pathway inhibitor. |
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Olaparib plus Abiraterone Versus Placebo plus Abiraterone in mCRPC (PROpel): Final Prespecified Overall Survival Results of a Randomised, Double-Blind, Phase 3 Trial
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Fred Saad, MD, FRCS
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| PROpel met its primary endpoint showing statistically significant improvement in radiographic progression-free survival with olaparib plus abiraterone versus placebo plus abiraterone in patients with first-line mCRPC unselected by homologous recombination repair mutation (HRRm) status, with benefit observed in all prespecified subgroups. Here, Fred Saad reports the final prespecified overall survival analysis.
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TALAPRO-2 Analysis: Talazoparib Enzalutamide Combo in Pretreated mCRPC
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Neeraj Agarwal, MD, FASCO
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| Neeraj Agarwal discusses a post-hoc analysis of the TALAPRO-2 Phase III study, which evaluates the efficacy of talazoparib and enzalutamide in metastatic castrate-resistant prostate cancer patients with prior ARPI or docetaxel treatment. |
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| Patient-Reported Outcomes in Patients with BRCA1/2-Altered mCRPC Receiving Niraparib with Abiraterone Acetate and Prednisone: Results from the MAGNITUDE Study
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| Dana E. Rathkopf, MD
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| Dana Rathkopf presents patient-reported outcomes from the MAGNITUDE study, which evaluated niraparib + abiraterone acetate and prednisone (AAP) in mCRPC patients with BRCA1/2 alterations. The results show a trend toward delayed pain progression and maintenance of health-related quality of life compared to placebo + AAP.
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| BRCAAway: A Randomized Phase 2 Trial of Abiraterone, Olaparib, or Abiraterone + Olaparib in Patients with mCRPC Bearing HRR Mutations |
| Maha Hussain, MD |
| Maha Hussain presents the results from the BRCAAway trial, a phase 2 study comparing abiraterone, olaparib, and their combination in mCRPC patients with BRCA1/2 or ATM mutations. The combination of olaparib and abiraterone significantly improved progression-free survival compared to either agent alone and was well-tolerated. These findings align with the FDA’s recent approval of this combination as first-line therapy for mCRPC with BRCA1/2 alterations. |
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| PSMA Radioligand Therapy: The VISION and TheraP Trials |
| Michael Morris, MD
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| Michael Morris discusses the VISION trial, which showed that 177Lu-PSMA-617 combined with standard of care significantly improved overall survival and radiographic progression-free survival in mCRPC patients compared to standard of care alone. These findings establish 177Lu-PSMA-617 as an effective treatment option with consistent benefits across secondary endpoints. |
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| Efficacy of 177Lu-PNT2002 in PSMA-Positive mCRPC Following Progression on an Androgen-Receptor Pathway Inhibitor (SPLASH) |
| A. Oliver Sartor, MD |
| Oliver Sartor presents interim results from the SPLASH trial at ESMO 2024, evaluating 177Lu-PNT2002 in PSMA-positive mCRPC following progression on ARPI therapy. The trial met its primary endpoint, with 177Lu-PNT2002 significantly improving radiographic progression-free survival compared to an alternate ARPI. Secondary endpoints, including objective response rate, PSA50 response, and health-related quality of life, also favored 177Lu-PNT2002, with a favorable safety profile and ongoing overall survival data maturation. |
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Curium Announces ECLIPSE Trial Has Met Primary Endpoint, Demonstrating a Statistically Significant and Clinically Meaningful Benefit for Patients With PSMA-Positive Metastatic Castration Resistant Prostate Cancer
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| Press Release |
| The ECLIPSE trial, a pivotal Phase 3 study, demonstrated a statistically significant and clinically meaningful improvement in rPFS for patients with PSMA-positive mCRPC treated with up to six doses of 177Lu-PSMA-I&T compared to continued ARPI therapy. This marks the first Phase 3 investigation of a 200 mCi dose administered every six weeks, showing clinical benefits for mCRPC patients prior to taxane chemotherapy. Curium plans to collaborate with the FDA for regulatory submissions as data matures, aiming to expand access to this promising radioligand therapy. |
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