bicalutamide / Generic mfg. - LARVOL DELTA

Long term results of NRG Oncology RTOG 9601, a randomized trial of radiation with or without anti-androgens (AAT) in patients receiving salvage prostate bed radiation therapy post prostatectomy. (PubMed, Int J Radiat Oncol Biol Phys) - "Long term results of 24-month duration AAT during and after salvage RT are consistent with the primary report with significantly improved long-term OS, reduced incidence of metastatic PC and PC death for RT+AAT. In comparison to previous reports, the improvement in overall survival with AAT has risen from 5% at 12 years to 9·8% at 18 years."

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

Three- and Seven-month Prostate-specific Antigen Levels as Prognostic Markers for Overall Survival in Metastatic Hormone-sensitive Prostate Cancer: Results from SWOG S1216, a Phase 3 Randomized Trial of Androgen Deprivation Plus Orteronel or Bicalutamide. (PubMed, Eur Urol Oncol) - "The PSA-3mo and PSA-7mo responses were strongly associated with OS; taken with other emerging prognostic biomarkers, these markers may allow for early identification of patients at the highest risk of death, aid with counseling in clinical practice, and permit design of future clinical trials targeting these patients."

Biomarker • Journal • Metastases • P3 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

ARCH: Contributions to Hypertension With Androgen Deprivation Therapy (clinicaltrials.gov) - P4 | N=10 | Terminated | Sponsor: University of Colorado, Denver | Completed ➔ Terminated; Study completed

Trial termination • Cardiovascular • Genito-urinary Cancer • Hypertension • Nephrology • Oncology • Prostate Cancer • Renal Disease • Solid Tumor

Rezvilutamide versus bicalutamide in combination with androgen-deprivation therapy in patients with high-volume, metastatic, hormone-sensitive prostate cancer (CHART): a randomised, open-label, phase 3 trial. (PubMed, Lancet Oncol) - P3 | "In the two interim analyses, rezvilutamide plus ADT significantly improved radiographic progression-free survival and overall survival compared with bicalutamide plus ADT in patients with high-volume, metastatic, hormone-sensitive prostate cancer, with a tolerable safety profile."

Combination therapy • Journal • P3 data • Cardiovascular • Dyslipidemia • Genito-urinary Cancer • Hematological Disorders • Hypertension • Oncology • Prostate Cancer • Solid Tumor

Bone Pain and Survival Among Patients With Metastatic, Hormone-Sensitive Prostate Cancer: A Secondary Analysis of the SWOG-1216 Trial. (PubMed, JAMA Netw Open) - P3 | "In the SWOG-1216 trial, patients were randomized (1:1) to receive either androgen deprivation therapy (ADT) with orteronel, 300 mg orally twice daily (experimental group), or ADT with bicalutamide, 50 mg orally daily (control group), until disease progression, unacceptable toxic effects, or patient withdrawal. These data suggest prioritizing these patients for enrollment in clinical trials, may aid patient counseling, and indicate that the inclusion of bone pain in prognostic models of MHSPC may be warranted. ClinicalTrials.gov Identifier: NCT01809691."

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

Prostate-specific antigen value at 3 & 7 months (PSA-3mo, PSA-7mo) and overall survival (OS) in metastatic hormone-sensitive prostate cancer (mHSPC) treated with androgen deprivation (ADT) with or without orteronel (SWOG S1216). (ASCO 2023) - P3 | "Background: Analysis of phase 3 studies of patients (pts) with mHSPC in the era of ADT, including in combination with docetaxel and/or androgen receptor axis targeted therapies have established PSA-7mo as a key prognostic marker. Our objective was to evaluate the association between PSA-3mo, PSA 7-mo and OS measured in the phase 3 S1216 trial in mHSPC comparing ADT + orteronel (treatment arm) vs ADT + bicalutamide (control arm) [NCT01809691]... PSA-3mo and PSA-7mo are strong prognostic markers for pts with mHSPC. More pts on ADT with orteronel achieved CR at 3 and 7 mo. In addition to its use in counseling patients in the clinic, PSA-3mo and PSA-7mo may be used as parameters for designing future trials in pts with mHSPC, utilizing the next generation of intensification or de-intensification treatment regimens."

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

FORMULA-509: A Multicenter Randomized Trial of Postprostatectomy Salvage Radiotherapy and 6 months of a GNRH Agonist with Either Bicalutamide or Abiraterone Acetate plus Prednisone and Apalutamide. (PubMed, Eur Urol) - P2 | "This study did not reveal a benefit for the overall population, but addition of AAP + apalutamide (vs bicalutamide) to sRT and ADT improved PFS and MFS in the prespecified subgroup with PSA >0.5 ng/ml."

Journal • Cardiovascular • Genito-urinary Cancer • Hypertension • Oncology • Prostate Cancer • Solid Tumor

Time to metastasis after prostatectomy (TTM) and survival outcomes in patients (pts) with metachronous metastatic hormone-sensitive prostate cancer (mHSPC): A secondary analysis of the SWOG 1216 phase 3 trial. (ASCO-GU 2025) - P3 | "Therefore, we assessed the prognostic value of TTM using the SWOG 1216 trial data which randomized pts with mHSPC to androgen deprivation therapy (ADT) with orteronel (ORT) or bicalutamide (bic) (NCT01809691). The timing of metastatic disease after prostatectomy in pts with metachronous mHSPC did not appear to be related to survival and should not be used as a prognostic factor nor to predict treatment outcomes."

Clinical • Metastases • P3 data • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

A randomised phase II study to evaluate the efficacy and safety of androgen deprivation therapy (ADT) vs chemotherapy (CT) in patients with recurrent and/or metastatic, androgen receptor (AR) expressing, salivary gland cancers (ESMO 2024) - P2 | "To assess the value of ADT, an EORTC-led randomised phase II study was launched. Patients (pts) with untreated R/M/U AR expressing SDC and ADC (cohort A) were randomised to receive CT (cisplatin 75 mg/m2 + doxorubicin 60 mg/m2 or carboplatin AUC 5 + paclitaxel 175 mg/m2 q3 weeks for a maximum of 6 cycles) or ADT (bicalutamide 50 mg once daily + triptorelin 3.75 mg q 28 days until progressive disease (PD)). PFS in R/M/U AR expressing SGCs ADT did not prove superior nor inferior. ADT sensitivity is seen independently of treatment sequence, line and HER2 amplification. ADT combined with CT and/or with HER2 inhibitors, depending on HER2 status, might represent a rational approach for future studies."

Clinical • Late-breaking abstract • Metastases • P2 data • Head and Neck Cancer • Oncology • Salivary Gland Cancer • Solid Tumor • AR

FORMULA-509: A multicenter randomized trial of post-operative salvage radiotherapy (SRT) and 6 months of GnRH agonist with or without abiraterone acetate/prednisone (AAP) and apalutamide (Apa) post-radical prostatectomy (RP). (ASCO-GU 2023) - P2 | "All patients received SRT plus 6 months of GnRH agonist and randomization was to concurrent bicalutamide 50 mg or AAP 1000mg/5mg + Apa 240mg QD. Although this primary analysis did not meet the pre-specified threshold for statistical significance, it does strongly suggest that the addition of AAP/Apa to SRT+6 months of ADT may improve PFS and MFS, particularly in the subgroup of patients with PSA>0.5 where a pre-planned subgroup analysis by stratification factors observed a statistically significant benefit for both PFS and MFS. Clinical trial information: NCT03141671."

Clinical • Genito-urinary Cancer

Duration of androgen deprivation therapy with postoperative radiotherapy for prostate cancer: a comparison of long-course versus short-course androgen deprivation therapy in the RADICALS-HD randomised trial. (PubMed, Lancet) - P3 | "Compared with adding 6 months of ADT, adding 24 months of ADT improved metastasis-free survival in people receiving postoperative radiotherapy. For individuals who can accept the additional duration of adverse effects, long-course ADT should be offered with postoperative radiotherapy."

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

Metformin for biochemical recurrence of prostate cancer: Immune data from a phase 2 study. (ASCO-GU 2023) - P2 | " We conducted an open label, randomized, phase II trial of bicalutamide with or without metformin of patients with high risk, biochemically recurrent prostate cancer (NCT02614859). Metformin has been shown to reduce markers of immune exhaustion in hormone sensitive prostate cancer which is supported by a greater reduction of PD-1+ and Tim3+ NK cells. Additional immune changes included increases in activated subpopulations of natural killer (NK) cells, which have been reported as a potential predictive biomarker of prolonged treatment response to hormone therapy in prostate cancer (Pasero et al, Oncotarget, 2015). Clinical trial information: NCT02614859."

IO biomarker • P2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD8 • ENTPD1 • HAVCR2 • PD-1

NRG-GU002: Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery (clinicaltrials.gov) - P2/3 | N=612 | Active, not recruiting | Sponsor: NRG Oncology | Completed ➔ Active, not recruiting | Trial completion date: Oct 2025 ➔ Oct 2030

Enrollment closed • Trial completion date • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Correlation of body mass index (BMI) with survival outcomes in patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC): Analysis of patient (pt)-level data from SWOG 1216 study. (ASCO 2024) - P3 | "Herein we report the correlation of BMI with survival outcomes from patient level data from phase III study, SWOG 1216 which randomized pts with mHSPC in 1:1 to ADT + bicalutamide or ADT + orteronel. Our results show that as categorized BMI increased, the risk of death decreased in pts with mHSPC. These data warrant external validation in other randomized phase III studies and can help counseling and prognostication of patients with mHSPC in the clinic. Funding: NIH/NCI grants CA180888, CA180819, and in part by Millennium Pharmaceuticals (Takeda Oncology Company)."

Clinical • Metastases • Genetic Disorders • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Obesity • Oncology • Prostate Cancer • Solid Tumor

Association of Presalvage Radiotherapy PSA Levels After Prostatectomy With Outcomes of Long-term Antiandrogen Therapy in Men With Prostate Cancer. (PubMed, JAMA Oncol) - P3 | "Men were randomized to SRT plus high-dose nonsteroidal antiandrogen (bicalutamide, 150 mg/d) or placebo for 2 years...Future randomized clinical trials are needed to determine hormonal therapy benefit in this population. ClinicalTrials.gov Identifier: NCT00002874."

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

Adding 6 months of androgen deprivation therapy to postoperative radiotherapy for prostate cancer: a comparison of short-course versus no androgen deprivation therapy in the RADICALS-HD randomised controlled trial. (PubMed, Lancet) - P3 | "Metastatic disease is uncommon following postoperative bed radiotherapy after radical prostatectomy. Adding 6 months of ADT to this radiotherapy did not improve metastasis-free survival compared with no ADT. These findings do not support the use of short-course ADT with postoperative radiotherapy in this patient population."

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

Outcomes of Black (B) versus White (W) patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC) treated with androgen deprivation therapy (ADT) with or without orteronel (Ort): Analysis of pt-level data from SWOG-1216 phase 3 trial. (ASCO 2023) - "In the phase 3 S1216 trial, treatment with Ort, a novel CYP17 axis inhibitor, significantly improved progression-free survival (PFS) but not overall survival (OS) compared to bicalutamide (Bic) in pts with mHSPC receiving ADT. We demonstrate that even though B pts present with more aggressive disease in mHSPC setting, they did not have statistically significant worse OS and PFS than W pts and treatment effect was also similar for both racial groups. Equitable access to care may negate historical differences in outcomes among B vs W pts with advanced PCa. Funding: NIH/NCI/NCTN grant U10CA180888, U10CA180819; and Millennium Pharmaceuticals (Takeda Oncology)."

Clinical • Metastases • P3 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Baseline bone pain as a prognostic marker for survival for men with metastatic hormone-sensitive prostate cancer (mHSPC): Patient-level analysis of SWOG 1216 trial. (ASCO-GU 2024) - P3 | "Therefore, SWOG 1216 trial data which randomized men with mHSPC to androgen deprivation therapy (ADT) with orteronel vs bicalutamide was evaluated (PMID: 35446628,NCT01809691). Men with mHSPC with bone pain at baseline have worse survival outcomes despite treatment intensification and may be prioritized for enrollment in clinical trials. These data may aid patient counseling and warrant the inclusion of bone pain in the prognostic models of mHSPC. Clinical trial information: NCT01809691."

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

The prognostic impact of prostate-specific antigen at 6 months after post-prostatectomy radiotherapy: An individual patient data analysis of two NRG oncology randomized trials. (ASCO-GU 2025) - "HT was either androgen deprivation therapy (ADT) for 4-6 months or bicalutamide for 2 years... PSA >0.1 ng/mL within 6 months was prognostic for OS and MFS in patients treated with salvage RT in the post-prostatectomy setting. This finding allows better patient counseling and can guide clinical trial design for treatment intensification or de-intensification in patients receiving salvage RT."

Clinical • Genito-urinary Cancer • Oncology • Prostate Cancer

A phase 3 trial of SHR3680 versus bicalutamide in combination with androgen deprivation therapy (ADT) in patients with high-volume metastatic hormone-sensitive prostate cancer (mHSPC). (ASCO 2022) - P3 | "SHR3680 plus ADT significantly improved rPFS versus Bica plus ADT in pts with high-volume mHSPC, with a desirable safety profile. New drug application has been submitted to seek approval based on the data presented here."

Clinical • Combination therapy • P3 data • CNS Disorders • Epilepsy • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Testosterone suppression plus enzalutamide versus testosterone suppression plus standard antiandrogen therapy for metastatic hormone-sensitive prostate cancer (ENZAMET): an international, open-label, randomised, phase 3 trial. (PubMed, Lancet Oncol) - P3 | "The addition of enzalutamide to standard of care showed sustained improvement in overall survival for patients with metastatic hormone-sensitive prostate cancer and should be considered as a treatment option for eligible patients."

Journal • Metastases • P3 data • Alzheimer's Disease • Cardiovascular • CNS Disorders • Fatigue • Febrile Neutropenia • Genito-urinary Cancer • Hematological Disorders • Hypertension • Neutropenia • Oncology • Prostate Cancer • Solid Tumor

Patient-reported health-related quality of life (HRQoL) in the randomized FORMULA-509 trial of salvage radiotherapy and 6 months of GnRH agonist with either bicalutamide or abiraterone acetate plus prednisone (AAP) and apalutamide (Apa) after radical prostatectomy (RP). (ASCO-GU 2024) - P2 | "The addition of AAP/Apa improved oncologic outcomes without causing a detectable difference in patient-reported hormonal function, fatigue, or mental status compared to bicalutamide. Clinical trial information: NCT03141671."

Clinical • HEOR • Genito-urinary Cancer

Prostate Specific Membrane Antigen (PSMA) Imaging for Detection of Residual and Metastatic Prostate Cancer (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: Washington University School of Medicine | Trial completion date: Oct 2027 ➔ Jan 2028 | Initiation date: Jul 2026 ➔ Oct 2026 | Trial primary completion date: Aug 2027 ➔ Nov 2027

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

Orteronel for Metastatic Hormone-Sensitive Prostate Cancer: A Multicenter, Randomized, Open-Label Phase III Trial (SWOG-1216). (PubMed, J Clin Oncol) - "The study did not meet the primary end point of improved OS with orteronel. The lack of correlation of PFS and PSA response with OS raises concerns over assumption of their consistent surrogacy for OS in the context of extensive postprotocol therapy in this setting."

Journal • P3 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Orteronel for Metastatic Hormone-Sensitive Prostate Cancer: A Multicenter, Randomized, Open-Label Phase III Trial (SWOG-1216). (SWOG-Fall 2022) - P3 | " In this open-label randomized phase III study, patients with metastatic hormone-sensitive prostate cancer were randomly assigned 1:1 to ADT with orteronel (300 mg oral twice daily; experimental arm) or ADT with bicalutamide (50 mg oral once daily; control arm). The study did not meet the primary end point of improved OS with orteronel. The lack of correlation of PFS and PSA response with OS raises concerns over assumption of their consistent surrogacy for OS in the context of extensive postprotocol therapy in this setting."

Clinical • P3 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor