Firmagon (degarelix) / Astellas, Ferring - LARVOL DELTA

Rectum Reveals the Prostate: A Rare Case of Metastatic Prostate Adenocarcinoma (ACG 2026) - "The patient was diagnosed with metastatic prostate adenocarcinoma and initiated on androgen deprivation therapy with degarelix and bicalutamide, with plans for outpatient systemic therapy. This case highlights the importance of considering metastatic prostate cancer in the differential diagnosis of a rectal mass, particularly in older male patients presenting with lower gastrointestinal bleeding. Figure: Image 1: Colonoscopy shows rectal mass"

Clinical • Metastases • Colorectal Cancer • Gastroenterology • Gastrointestinal Disorder • Genito-urinary Cancer • Hepatology • Oncology • Peritoneal Cancer • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • CEACAM5

A Study of BMS986365 in Combination With Degarelix in People With Prostate Cancer (clinicaltrials.gov) - P2 | N=7 | Active, not recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | N=30 ➔ 7 | Recruiting ➔ Active, not recruiting

Enrollment change • Enrollment closed • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

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

Targeting androgen signaling in urothelial carcinoma (AACR 2024) - P1 | "In a study of 9 men and 1 woman with metastatic UC, all patients were treated with gemcitabine/cisplatin and concurrent enzalutamide...In our study (TASUC; NCT05839119), we add degarelix to standard neoadjuvant chemotherapy to treat men and women who have AR positive UC.The main eligibility criteria are:(1) Muscle-invasive urothelial carcinoma of the bladder (2) AR positive disease by nuclear staining on immunohistochemistry (3) pT2 - T4, N0 - N1, M0 (Stage II or IIIA disease) (4) Eligible for cisplatin-based chemotherapy (5) Eligible for cystectomyIn this single-arm study, all patients receive standard of care gemcitabine/cisplatin neoadjuvant chemotherapy (4 cycles) with the addition of monthly degarelix during chemotherapy...If we observe at least 14 pCRs (of 32 patients) the study will be considered positive and we will plan a follow-up randomized, controlled phase II (or phase III) study.Exploratory outcomes include correlation of AR positivity with..."

Bladder Cancer • Oncology • Prostate Cancer • Solid Tumor • Urothelial Cancer • AR

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

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

Final oncological outcomes of the randomized phase II trial ARNEO: neoadjuvant degarelix with or without apalutamide prior to radical prostatectomy for high-risk prostate cancer (AUA 2025) - "At 3 years follow-up, no statistically significant difference in terms of BCR was observed between patients treated with neoadjuvant DEG+APA or DEG alone. MRD was not associated with improved BCR-free survival. However, ypT2 and SCD disease following neoadjuvant hormonal therapy was highly associated with improved BCR-free survival, suggesting that ypT2 and SCD disease might be used as a surrogate endpoints for improved BCR-free survival in future surgical trials investigating neoadjuvant hormonal therapy."

Clinical • P2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Efficacy and Safety of Radiotherapy Plus Relugolix in Men With Localized or Advanced Prostate Cancer. (PubMed, JAMA Oncol) - "This multicenter post hoc analysis of patients with localized and advanced prostate cancer receiving radiotherapy in 2 randomized clinical trials (a phase 2 trial of relugolix vs degarelix, and a subset of the phase 3 HERO trial of relugolix vs leuprolide acetate) included men who were receiving radiotherapy and short-term (24 weeks) ADT (n = 103) from 2014 to 2015 and men receiving radiotherapy and longer-term (48 weeks) ADT (n = 157) from 2017 to 2019...Patients receiving longer-term ADT received relugolix, 120 mg, orally once daily (360-mg loading dose) or leuprolide acetate injections every 12 weeks for 48 weeks, with up to 90 days of follow-up...The results of these 2 randomized clinical trials suggest that relugolix rapidly achieves sustained castration in patients with localized and advanced prostate cancer receiving radiotherapy. No new safety concerns were identified when relugolix was used with radiotherapy."

Clinical • Journal • Metastases • Atrial Fibrillation • Cardiovascular • Genito-urinary Cancer • Hypertension • Oncology • Pain • Prostate Cancer • Solid Tumor

ENHANCE: Evaluating Hormone Therapy to Achieve Optimal Doses in Metastatic Prostate Cancer (clinicaltrials.gov) - P3 | N=1500 | Recruiting | Sponsor: University College, London | Not yet recruiting ➔ Recruiting

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

Short Course ADT for High Risk Low/Intermediate Risk ARTERA Prostate Cancer (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: NYU Langone Health

New P2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Fewer Injections and Lower Drug Costs With Long-Acting GnRH Depot Formulations: A Nationwide Analysis of 2.3 Million Patient-Years in Japan. (PubMed, Cancer Rep (Hoboken)) - "The shift to long-acting GnRH formulations was associated with a reduction in injections of about one in five, even though the number of patients increased and was estimated to account for part of the reduction in drug cost. Because the oncological effect is similar among GnRH drugs, a further shift to long-acting formulations may lower the burden on patients and on health care."

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

Game changing session 3 : Game changing session: Randomized phase II trial of neoadjuvant degarelix with or without apalutamide prior to radical prostatectomy for unfavorable intermediate- and high-risk prostate cancer (EAU 2022) - No abstract available

Clinical • P2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Phase I Clinical Trial Evaluating the Safety and Dosing of Relugolix with Novel Hormonal Therapy for the Treatment of Advanced Prostate Cancer. (PubMed, Target Oncol) - P1 | "Combination therapy of relugolix and abiraterone or apalutamide was associated with a favorable safety and tolerability profile consistent with the known profiles of the individual medications. Castration levels of testosterone were maintained after transitioning to relugolix from other ADTs."

Journal • Metastases • P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A phase 2 study of androgen deprivation therapy and the androgen receptor ligand–directed degrader (BMS-986365) prior to radical prostatectomy in patients with high-risk localized prostate cancer. (ASCO 2026) - P2, P3 | "An ongoing phase 3 study is evaluating ADT plus apalutamide for 6 months prior to RP in pts with high-risk or locally advanced PC; co-primary endpoints are pathologic complete response (pCR) and metastasis-free survival (NCT03767244)...Pts will receive degarelix SC once monthly (first dose 240mg, maintenance dose 80mg) and BMS-986365 at a dose of 300mg PO twice daily (liquid-filled capsule formulation) for 6 months; RP will occur 2 weeks after the last dose of BMS-986365...As part of exploratory analyses, cfDNA, pre-/post-treatment (prostatectomy) tissue, and pre-/post-treatment multiparametric MRI will be collected. The study opened to accrual in January 2026."

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

Initial Results of a Phase 2 Trial of Stereotactic Body Radiation Therapy, Hormone/Androgen Deprivation Therapy and Radium 223 Dichloride for Oligometastatic Castrate Sensitive Prostate Cancer (SHARP) (ASTRO 2024) - P2 | "Materials/ ADT (degarelix [n=4], relugolix [n=2], or leuprolide [n=19]) was administered starting at least 4 weeks prior to SBRT and continued for 36 weeks. Ra-223 combined with SBRT to oligometastases and 36 weeks ADT in mCSPC is well-tolerated and results in favorable OS and PFS compared to historical controls. Longer follow-up is necessary to assess if the early use of Ra-223 delays development of new bone metastases."

Metastases • P2 data • Anemia • Cardiovascular • Gastroenterology • Genito-urinary Cancer • Hematological Disorders • Hepatology • Hypertension • Leukopenia • Metastatic Castration-Resistant Prostate Cancer • Musculoskeletal Diseases • Neutropenia • Oncology • Prostate Cancer • Solid Tumor • CXCL8 • TNFA

ARNEO: A Randomized Phase II Trial of Neoadjuvant Degarelix with or Without Apalutamide Prior to Radical Prostatectomy for High-risk Prostate Cancer. (PubMed, Eur Urol) - "In high-risk PCa patients, neoadjuvant degarelix plus apalutamide prior to RP results in a significantly improved pathological response (MRD and RCB) compared with degarelix alone. Our trial results provide a solid hypothesis-generating basis for neoadjuvant phase 3 trials, which are powered to detect differences in long-term oncological outcome following neoadjuvant androgen receptor signaling inhibitor therapy."

Journal • P2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • PTEN

Neoadjuvant Antiandrogen Therapy With or Without MEK or SRC Inhibition for Unfavorable-risk Prostate Cancer: A Phase 2 Randomized Clinical Trial. (PubMed, Eur Urol Oncol) - "Neoadjuvant SRC or MEK inhibition does not appear to mitigate the EMT response to ADT or influence clinical or pathological outcomes."

Clinical • Journal • P2 data • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • CDH2 • MAP2K1 • MAP2K2 • VIM

GETUG-AFU 22 Phase II Randomized Trial Evaluating Outcomes of Post-Operative Immediate Salvage Radiation Therapy with or without ADT for Patients with Persistently Elevated PSA Level (ASTRO 2022) - "Materials/ RP patients with nonmetastatic PCa on conventional preoperative imaging, and with a post-RP PSA level between 0.2 and 2 ng/mL were randomized (1:1) to iSRT alone (iSRT arm) or 6 months of ADT (degarelix) with iSRT (iSRT+ADT arm)... Despite the lack of differences in terms of EFS between the two arms, this study demonstrated that iSRT+ADT improved MFS without impaired quality-of-life for patients with persistently elevated PSA after RP."

Clinical • Late-breaking abstract • P2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Effect of neoadjuvant androgen deprivation therapy on prostate and tumor morphology prior to MRI-guided transurethral ultrasound ablation of prostate cancer. (PubMed, Int J Hyperthermia) - P1 | "Short-term nADT with degarelix was associated with significant changes in prostate and tumor morphology. Future studies should determine whether these changes improve TULSA outcomes."

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

Irradiation plus long-term adjuvant androgen deprivation with GnRH antagonist vs. GnRH agonist in patients with very high risk localized or locally advanced prostate cancer: The EORTC GUCG-1414 phase III PEGASUS randomized trial (EMUC 2024) - "Conclusions In patients with very high-risk prostate cancer treated with EBRT and long-term ADT, GnRH antagonist failed to demonstrate a superiority over LHRH agonists in achieving a PSA nadir <0.1ng/mL within 6 months after EBRT, a prognostic factor of long-term outcome. In patients with preexisting cardiovascular disease at baseline, a lower rate of further CVEs and treatment-related deaths was observed with degarelix."

Clinical • Metastases • P3 data • Cardiovascular • Genito-urinary Cancer • Infectious Disease • Nephrology • Oncology • Prostate Cancer • Solid Tumor

GETUG-AFU 22 phase II randomized trial : final results on clinical outcomes with immediate SRT (ESTRO 2023) - "Material and Methods RP patients with non metastatic PCa on conventional preoperative imaging, and with a post-RP PSA level between 0.2 and 2 ng/mL were randomized (1:1) to iSRT alone (iSRT arm) or 6 months of ADT (degarelix) with iSRT (iSRT+ADT arm)...After an initial 25-fold decrease in blood testosterone level, all patients recovered to normal level 12 months after starting ADT Conclusion This study demonstrated that iSRT+ADT is the most effective arm and improved MFS with good tolerance for patients with persistently elevated PSA after RP. iSRT+ADT may be used as reference arm for a phase III study."

Clinical • Clinical data • P2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial (clinicaltrials.gov) - P3 | N=2753 | Active, not recruiting | Sponsor: NRG Oncology | Trial completion date: Dec 2033 ➔ Dec 2038

Trial completion date • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • CD4

Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score, The Guidance Trial (clinicaltrials.gov) - P3 | N=2050 | Active, not recruiting | Sponsor: NRG Oncology | Trial completion date: Nov 2026 ➔ Nov 2031

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

Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors (clinicaltrials.gov) - P2 | N=47 | Active, not recruiting | Sponsor: Xiao X. Wei, MD | Trial completion date: Jun 2026 ➔ Oct 2026

Trial completion date • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

ENHANCE: Evaluating Hormone Therapy to Achieve Optimal Doses in Metastatic Prostate Cancer (clinicaltrials.gov) - P3 | N=1500 | Not yet recruiting | Sponsor: University College, London

New P3 trial • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor