Provenge (sipuleucel-T) / Bausch Health - LARVOL DELTA

Deep and Durable Prostate-Specific Antigen Response Following Comprehensive Involved Site Radiotherapy for Prostate Cancer Oligometastases (ASTRO 2025) - "The types of systemic therapy consisted of 91% androgen deprivation therapy, 66% androgen receptor pathway inhibitor, 9% docetaxel, 3% radium-223, 3% sipuleucel-T, and 3% none. Comprehensive involved site radiotherapy is effective at achieving undetectable PSA in patients with hormone-sensitive oligometastases. Longer-term follow-up is needed to determine if these results are durable."

Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Trial in Progress: Randomized Phase II Trial of Targeted Radiation with No Castration for Treatment of Metastatic Castration-Resistant Prostate Cancer (ASTRO 2025) - "Exclusion criteria include visceral (liver/brain) metastases, prior PSMA RLT or radium-223 treatment, small cell/neuroendocrine prostate cancer, or impending spinal cord compression. Prior PARP inhibitors, sipuleucel-T, or pembrolizumab are allowed. Following ADT discontinuation, patients are randomized 1:1 into two arms: (1) PSMA RLT (177Lu vipivotide tetraxetan) for 2 cycles with intervening SBRT in 1–5 fractions delivered to all sites of active disease, or (2) the same treatment but with daily transdermal testosterone gel initiated if post-treatment imaging is consistent with no active sites of disease... This trial challenges the conventional indefinite ADT paradigm in mCRPC by assessing whether a non-hormonal approach combining PSMA RLT and SBRT without ongoing testosterone suppression can improve oncologic outcomes and quality of life. If successful, this study may establish a novel treatment framework for mCRPC management."

Clinical • Metastases • P2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Neuroendocrine Tumor • Oncology • Prostate Cancer • Solid Tumor • AR

Study of Sipuleucel-T With or Without Continuing New Hormonal Agents in Metastatic Prostate Cancer (clinicaltrials.gov) - P2 | N=26 | Recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Trial primary completion date: Aug 2025 ➔ Dec 2025

Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Prostate Cancer Immunotherapy: Time to Move Beyond Checkpoint Inhibitors. (PubMed, Immunotargets Ther) - "Prior to the advent of ICIs, prostate cancer had one of the first approvals for cancer immunotherapy with sipleucel-T, an anti-cancer vaccine...Most notably, clinical trials with bispecific T-cell engagers (BiTEs) targeting tumor antigens like STEAP-1 and KLK2 have shown clinical promise. Moving beyond ICIs may lead to new approaches to alter the prostate cancer tumor immune microenvironment and improve clinical outcomes."

Checkpoint inhibition • Journal • Review • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • KLK2 • STEAP1

Chimeric Antigen Receptor-Engineered (CAR)-T Cell Therapy for Metastatic Prostate Cancer. (PubMed, Cancer Lett) - "These include androgen receptor signaling inhibitors such as enzalutamide and abiraterone acetate, taxane-based chemotherapies including docetaxel and cabazitaxel, and bone-targeting radiopharmaceuticals like radium-223. Immunotherapeutic agents have also contributed to expanding treatment options with Sipuleucel-T, a dendritic cell-based vaccine, and pembrolizumab, a PD-1 immune checkpoint inhibitor approved for select patient populations. Furthermore, the introduction of poly (ADP-ribose) polymerase inhibitors like olaparib and rucaparib, has transformed the therapeutic landscape, particularly for patients with DNA repair deficiencies in metastatic prostate cancer...In this review, we highlight adoptive cellular therapies utilizing CAR-T cells engineered to recognize prostate cancer-specific antigens, aiming to overcome immune evasion mechanisms. We summarize current CAR-T modalities with their limitations and prospects being evaluated in both preclinical and clinical..."

Journal • Review • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hematological Disorders • Hematological Malignancies • Neuroendocrine Tumor • Oncology • Prostate Cancer • Solid Tumor • DRD

A new frontier in oncology: Understanding the landscape of cancer vaccines. (PubMed, J Oncol Pharm Pract) - "This review explores the diverse platforms and mechanisms supporting cancer vaccines, ranging from prophylactic vaccines such as HPV and hepatitis B vaccines that have significantly reduced virus-related cancers to therapeutic vaccines like Sipuleucel-T and T-VEC that extend survival in prostate cancer and melanoma. In conclusion, cancer vaccines offer a less toxic, more precise approach to cancer prevention and treatment. Continued innovation, global collaboration, and infrastructure development are essential to realizing their full potential in improving patient outcomes and reducing the global cancer burden."

IO biomarker • Journal • Review • Genito-urinary Cancer • Hepatitis B • Infectious Disease • Melanoma • Oncology • Prostate Cancer • Solid Tumor

Sipuleucel- T: Understanding the Differences in Outcomes Amongst African American and Caucasian Prostate Cancer Patients. A TriNetX Study (MA-AUA 2025) - No abstract available

Clinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

ProvONE: Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T (clinicaltrials.gov) - P2 | N=400 | Recruiting | Sponsor: Dendreon | Not yet recruiting ➔ Recruiting | Phase classification: P3 ➔ P2

Enrollment open • Phase classification • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Immunotherapy in metastatic prostate cancer. (PubMed, Ther Adv Med Oncol) - "Despite these advances, the role of immunotherapy in standard prostate cancer (PCa) management is limited, and Sipuleucel-T is the only approved immunotherapeutic agent...Early phase data for TCE are promising, but the feasibility of adoption of TCEs into the clinic will depend on overcoming neutralising anti-drug antibodies and limiting toxicities. CAR-T cells have demonstrated feasibility and acceptable safety profiles in early phase clinical trials, and it is hoped that the ongoing development of later-generation constructs and therapeutic combinations will enhance outcomes."

Journal • Review • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Combinations of treatments based on radiotherapy or radionuclides to enhance immunotherapy efficacy in advanced prostate cancer: a systematic review. (PubMed, J Cancer Res Clin Oncol) - "We observed that combination of Ipilimumab with stereotactic beam radiotherapy (SBRT) at the dose of 8 Gy performed about 12 days (range 2-21) before immunotherapy was liked with trials with a significative gain in progression-free survival. Furtherly, we described better objective responses when immunotherapies, were associated with SBRT than radionuclides An exception was 177Lu-PSMA-617, which showed promising synergic results after few cycles of standard doses, suggesting a possible enhancing of immune system, in particular when associated with anti-PD1 (pembrolizumab). Due to the few data reported in literature, both for radiotherapy and radionuclides, however, future randomized trials should confirm these data."

Journal • Review • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Real-world outcomes among patients with metastatic castration-resistant prostate cancer (mCRPC) receiving guideline-recommended therapies after treatment with 177Lu-PSMA-617: A real-world prostate cancer disease observation (PRECISION) data platform analysis. (ASCO 2025) - "Guideline-recommended therapies included abiraterone, enzalutamide, darolutamide, apalutamide, cabazitaxel, docetaxel, pembrolizumab, sipuleucel-T, niraparib, olaparib, talazoparib, rucaparib, and radium-223. In this real-world analysis, the majority of patients who received guideline-recommended therapies after 177Lu-PSMA-617 achieved at least a PSA50 response, suggesting that 177Lu-PSMA-617 treatment does not preclude response to other subsequent therapies."

Clinical • Metastases • Real-world • Real-world evidence • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urology

Overall survival outcomes with sipuleucel-T (Sip-T) among Black men with metastatic castrate-resistant prostate cancer (mCRPC) also treated with androgen receptor pathway inhibitors (ARPI). (ASCO 2025) - "Our findings from an investigator-led retrospective analysis independent of sponsors provide independent clinical trial support of prior retrospective findings that suggest Black men with mCRPC who receive Sip-T may have a greater OS than White men. While our analysis controlled for factors that may influence the use of Sip-T, it is limited by potential unmeasured confounders or timing of Sip-T. Further, adequately powered prospective trials specifically evaluating outcomes with Sip-T by race in earlier clinical settings are needed."

Clinical • Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Overall survival in metastatic castration-resistant prostate cancer (mCRPC): A retrospective electronic medical record analysis of men treated with sipuleucel-T in community urology over 14 years. (ASCO 2025) - "Despite their high-risk disease, patients who received sipuleucel-T had a 44-month median OS, with 28% being alive at 5 years later. This highlights the potential therapeutic benefit of integrating sipuleucel-T into real-world treatment for mCRPC. Further analysis is needed, leveraging the rich nature of this dataset."

Metastases • Retrospective data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urology

Real-world treatment patterns, sequences, and outcomes in patients with mCRPC in US urology clinics. (ASCO 2025) - "Of the 1,914 patients treated with androgen receptor pathway inhibitors (ARPIs) pre-mCRPC, including enzalutamide (enza), abiraterone (abi), apalutamide, and darolutamide, 95.8%, were treated with ARPI ± ADT. This data indicates the majority of patients used ADT alone pre-mCRPC. ARPI rechallenge was the most common treatment sequence from pre-mCRPC to mCRPC among ARPI exposed patients. Less than half of the patients analyzed received 2L+ therapy."

Clinical • HEOR • Real-world • Real-world evidence • Castration-Resistant Prostate Cancer • Prostate Cancer • Urology

Treatment patterns and survival by race among men with metastatic castration-resistant prostate cancer (mCRPC) in the United States: A US electronic medical record database 2020-2023. (ASCO 2025) - "Line of therapy was identified as ARPI, chemotherapy, poly (ADP-ribose) polymerase inhibitors (PARPIs), immunotherapy (pembrolizumab, sipuleucel-T), radiopharmaceuticals (Ra-223, 177Lu-PSMA-RLT), alone or in combination...Overall, ARPI (62%) [abiraterone: 25%; enzalutamide: 24%; apalutamide: 9%; darolutamide 4%] and chemotherapy (22%) [docetaxel 16%; cabazitaxel 6%] were most common first-line treatment (1L Tx) for mCRPC... ARPI and chemotherapy remained the most utilized therapies in mCRPC from 2020 to 2023 in the US. Treatment and survival outcomes did not differ significantly between Whites and AAs in mCRPC. Treatment and survival by race in mCRPC.NE, not evaluable."

Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • AR

Focus on urological cancer (ESTRO 2025) - "Clinical trials exploring the combination of brachytherapy with immunotherapies such as nivolumab, pembrolizumab, durvalumab and others are ongoing, with preliminary data indicating improved outcomes in patients with advanced prostate cancer (2, 3)...However, based on the results of phase II trials, no statistically significant improvement in oncological outcomes was observed in patients receiving both sipuleucel-T and radiotherapy (5)...Although combining brachytherapy with immunotherapy holds promise, further research is required to optimise treatment regimens, including dose, fractionation, timing, and sequencing. Prospective clinical trials are critical to better understanding the interaction between these modalities."

IO biomarker • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urethral Cancer • Urology

Real-world outcomes among patients with metastatic castration-resistant prostate cancer (mCRPC) receiving guideline-recommended therapies after treatment with 177Lu-PSMA-617: A real-world prostate cancer disease observation (PRECISION) data platform analysis. (ASCO-GU 2025) - "Guideline-recommended therapies included abiraterone, enzalutamide, darolutamide, apalutamide, cabazitaxel, docetaxel, pembrolizumab, sipuleucel-T, niraparib, olaparib, talazoparib, rucaparib, and radium-223. In this real-world analysis, the majority of patients who received guideline-recommended therapies after 177Lu-PSMA-617 achieved at least a PSA50 response, suggesting that 177Lu-PSMA-617 treatment does not preclude response to other subsequent therapies."

Clinical • Metastases • Real-world • Real-world evidence • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Systemic Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer: ASCO Guideline Update. (PubMed, J Clin Oncol) - "Prior systemic therapy for castration-sensitive prostate cancer will determine subsequent therapy used for mCRPC. Continue androgen-deprivation therapy for patients with mCRPC indefinitely. Early adoption of somatic genetic testing and palliative care is recommended. Patients with mCRPC and bony metastases should receive a bone-protective agent. The panel recommends the combination of ARPI with PARPi in patients with BRCA1/2 alterations who did not receive prior ARPI. For patients who received prior ARPI, the panel recommends docetaxel chemotherapy. The panel recommends 177Lu-PSMA-617 or cabazitaxel chemotherapy for patients who receive prior ARPI and docetaxel chemotherapy. For patients with BRCA1/2 alterations who received prior ARPI, the panel recommends PARPi monotherapy. Radium 223 is recommended for patients with symptomatic bone-only disease. Evidence for optimal sequencing for mCRPC regimens is lacking.Additional information is available at..."

Journal • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Microsatellite Instability • Oncology • Palliative care • Prostate Cancer • Solid Tumor • BRCA1 • BRCA2 • MSI

Diversity, Equity, and Inclusion in Gene and Cell Therapies Clinical Trials (ISPOR 2025) - "The lowest enrollment was for atidarsagene autotemcel (7 participants), while sipuleucel-T had the highest (512 participants)...White participants were disproportionately represented, particularly in sipuleucel-T (90.0%) and talimogene laherparepvec (97.9%)... The findings revealed persistent racial disparities in gene and cell therapy clinical trials, with minority populations underrepresented and White participants comprising the majority. Achieving DEI in clinical trials remains a challenge, underscoring the need for greater efforts to address these disparities."

Clinical • Gene Therapies • Oncology

Study of Sipuleucel-T With or Without Continuing New Hormonal Agents in Metastatic Prostate Cancer (clinicaltrials.gov) - P2 | N=26 | Recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Mar 2025 ➔ Aug 2025

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

mRNA vaccines for prostate cancer: A novel promising immunotherapy. (PubMed, Biochim Biophys Acta Rev Cancer) - "These attempts have largely failed to improve survival, with the sole exception of sipuleucel-T, which extended the median overall survival of asymptomatic or minimally symptomatic metastatic CRPC (mCRPC) patients by four months...Compared to conventional vaccines, mRNA vaccines offer several unique advantages, including high production efficiency, low cost, high safety, strong immune response induction, and high adaptability and precision. These attributes make mRNA vaccines a promising frontier in the treatment of advanced PCa."

Journal • Review • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Infectious Disease • Novel Coronavirus Disease • Oncology • Prostate Cancer • Solid Tumor

EAU 2025: A Case of Progression After Triplet Therapy for mHSPC: Evidence for and Against a Second ARPI (UroToday) - "Of 2,559 patients with mCRPC, 1,980 (77%) received at least one line of life-prolonging therapy (abiraterone, enzalutamide, docetaxel, cabazitaxel, sipuleucel-T, or radium-223)...Dr. Tombal noted that each time a second androgen receptor pathway inhibitor has been used as a 'best valuable comparator', it showed significantly lower radiographic progression free survival and overall survival in most cases...Prolonged responses are sometimes seen, but androgen receptor pathway inhibitor switch should not replace active treatments such as cabazitaxel, PARP inhibitors, LuPSMA, or radium-223...One interpretation of PSMAfore is that slightly delaying the following line of treatment with an androgen receptor pathway inhibitor switch, especially in patients having received abiraterone, is not that detrimental"

Real-world • Castration-Resistant Prostate Cancer

Cancer Vaccines: A Novel Revolutionized Approach to Cancer Therapy. (PubMed, Indian J Clin Biochem) - "In therapeutic vaccine only three are approved: Sipuleucel T-cell vaccine for treatment refractory prostatic cancer, BCG vaccine for early bladder cancer and T-VEC for inoperable melanoma. Heterogeneity within and between cancer types, screening and identifying suitable antigen specific to tumors and selection of vaccine delivery platforms are challenges in the development of vaccines. Adoptive cell therapy, Chimeric antigen receptor T cell therapy are recent breakthrough for cancer treatment."

Journal • Review • Bladder Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Infectious Disease • Melanoma • Oncology • Prostate Cancer • Solid Tumor

OU-SCC-EXCITE: Sipuleucel-T Based Autologous Cellular Immunotherapy for Advanced Prostate Cancer (clinicaltrials.gov) - P1 | N=13 | Recruiting | Sponsor: University of Oklahoma | Trial completion date: Nov 2024 ➔ Dec 2026 | Trial primary completion date: Nov 2024 ➔ Jun 2026

Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Real-world treatment patterns and survival in men with metastatic castration-resistant prostate cancer (mCRPC) who previously progressed from metastatic hormone-sensitive prostate cancer (mHSPC) between 2020 to 2023 in the United States. (ASCO-GU 2025) - "Background: While androgen deprivation therapy (ADT) is a backbone for managing mHSPC, therapies initially approved for mCRPC, such as androgen receptor pathways inhibitors like abiraterone (ABI) and non-ABI ARPIs ( enzalutamide, apalutamide, darolutamide), and/or docetaxel, are now guideline-recommended for use in mHSPC...Line of therapy was identified as ABI, non-ABI ARPI, taxane-based chemotherapy, poly (ADP-ribose) polymerase inhibitors (PARPIs), immunotherapy (pembrolizumab, sipuleucel-T), radiopharmaceuticals (Ra-223, 177Lu-PSMA-RLT), alone or in combination... With more than half of patients having received ADT alone in mHSPC, use of ARPIs was the most common 1L Tx option in mCRPC. Back-to-back use of ARPI upon progression to mCRPC was common. These findings highlight the need to explore alternative treatment option in mCRPC beyond ARPIs to improve survival in men with mCRPC."

Clinical • HEOR • Metastases • Real-world • Real-world evidence • Castration-Resistant Prostate Cancer • Castration-Sensitive Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor