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    DRUG:

    leuprolide acetate for depot suspension

    i
    Other names: TAP-144-SR, TAP-144SR, TAP-144, TAP-144-SR (6M), DWJ 108J, PT105
    Company:
    Generic mfg.
    Drug class:
    GnRH agonist
    Related drugs:
    2d
    Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE Trial (clinicaltrials.gov)
    P2, N=532, Recruiting, Mayo Clinic | Trial completion date: May 2029 --> Feb 2031 | Trial primary completion date: May 2029 --> Feb 2031
    Trial completion date • Trial primary completion date
    |
    Xtandi (enzalutamide) • abiraterone acetate • Nubeqa (darolutamide) • apalutamide • triptorelin • goserelin acetate • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
    3d
    CGVV858A12101: Study of GVV858 as a single agent or in combination with endocrine therapy in patients with HR+/HER2- breast cancer and other advanced solid tumors (2025-521911-38-00)
    P1/2, N=26, Not yet recruiting, Novartis Pharma AG
    New P1/2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    fulvestrant • letrozole • goserelin acetate • leuprolide acetate for depot suspension
    5d
    Redefining standards: a comprehensive systematic review of practice changing advances in GU oncology from ASCO and ESMO 2025. (PubMed, Front Endocrinol (Lausanne))
    Key advances include: (1) In bladder cancer, perioperative durvalumab (NIAGARA) and enfortumab vedotin plus pembrolizumab (KEYNOTE-905/EV-303) set new standards, while HER2-targeted disitamab vedotin plus toripalimab (RC48-C016) improved metastatic survival...(3) In prostate cancer, enzalutamide plus leuprolide improved survival in high-risk biochemical recurrence (EMBARK). Capivasertib plus abiraterone benefited PTEN-deficient metastatic hormone-sensitive disease (CAPItello-281). The PSMAddition trial demonstrated that adding [177Lu]Lu-PSMA-617 to standard therapy significantly improved radiographic PFS in PSMA-positive mHSPC. Docetaxel scheduling was optimized (ARASAFE), and an AI model (STAMPEDE) identified patients for AR inhibitor benefit. Novel agents like saruparib and pasritamig showed promise...The 2025 evidence establishes multiple new standards of care across GU cancers, emphasizing biomarker-driven strategies, immunotherapy integration, novel resistance mechanisms, and treatment optimization. This synthesis provides an evidence-based framework for updating guidelines and highlights the move toward more personalized management, while noting persistent challenges and future research needs.
    Review • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PTEN (Phosphatase and tensin homolog)
    |
    FOLH1 positive
    |
    Keytruda (pembrolizumab) • Imfinzi (durvalumab) • docetaxel • Loqtorzi (toripalimab-tpzi) • Xtandi (enzalutamide) • abiraterone acetate • Truqap (capivasertib) • Aidixi (disitamab vedotin) • Padcev (enfortumab vedotin-ejfv) • saruparib (AZD5305) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • leuprolide acetate for depot suspension • pasritamig (JNJ-8343)
    7d
    NIRO: Norethindrone Impact on Receptiva Outcomes (clinicaltrials.gov)
    P=N/A, N=99, Completed, Inception Fertility Research Institute, LLC | Active, not recruiting --> Completed | N=700 --> 99 | Trial completion date: Jul 2026 --> Dec 2025
    Trial completion • Enrollment change • Trial completion date
    |
    BCL6 (B-cell CLL/lymphoma 6)
    |
    leuprolide acetate for depot suspension
    14d
    VA STARPORT: Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer (clinicaltrials.gov)
    P2/3, N=464, Recruiting, VA Office of Research and Development | Trial primary completion date: Mar 2026 --> Sep 2026
    Trial primary completion date
    |
    docetaxel • Xtandi (enzalutamide) • abiraterone acetate • prednisone • bicalutamide • apalutamide • triptorelin • goserelin acetate • flutamide • nilutamide • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
    14d
    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, NRG Oncology | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Nubeqa (darolutamide) • bicalutamide • triptorelin • goserelin acetate • flutamide • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension • Suprefact (buserelin acetate)
    20d
    A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing (clinicaltrials.gov)
    P2, N=88, Active, not recruiting, Fudan University | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • AR (Androgen receptor)
    |
    HER-2 overexpression • AR positive
    |
    trastuzumab rezetecan (SHR-A1811) • leuprolide acetate for depot suspension • AiRuiEn (rezvilutamide) • tizetatug rezetecan (SHR-A1921)
    20d
    ADEPT: A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer (clinicaltrials.gov)
    P2, N=393, Active, not recruiting, Dana-Farber Cancer Institute | Recruiting --> Active, not recruiting | Trial primary completion date: Sep 2026 --> Mar 2026
    Enrollment closed • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 negative
    |
    Herceptin (trastuzumab) • tamoxifen • Perjeta (pertuzumab) • letrozole • anastrozole • exemestane • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf) • leuprolide acetate for depot suspension
    20d
    Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing (clinicaltrials.gov)
    P2, N=39, Recruiting, Peking Union Medical College | Trial primary completion date: Jul 2026 --> Jul 2028
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    carboplatin • Perjeta (pertuzumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Lenvima (lenvatinib) • AiRuiKa (camrelizumab) • AiTan (rivoceranib) • Piqray (alpelisib) • Irene (pyrotinib) • albumin-bound paclitaxel • abiraterone acetate • fulvestrant • Aidixi (disitamab vedotin) • exemestane • Padcev (enfortumab vedotin-ejfv) • bicalutamide • Kaitanni (cadonilimab) • goserelin acetate • Qibeian (iparomlimab/tuvonralimab) • Yidafan (ivonescimab) • iparomlimab (QL1604) • leuprolide acetate for depot suspension • Entyvio (vedolizumab)
    29d
    Case Report: Successful natural conception and delivery in a primary cancer survivor involving the reproductive, respiratory, and endocrine systems auth. (PubMed, Front Oncol)
    She received six cycles of postoperative leuprorelin therapy...The polyp was resected, and the patient received a 14-day course of anti-infective therapy with metronidazole and levofloxacin, after which she was guided by natural conception...It establishes an MDT management pathway encompassing "determination of oncologic remission status, intervention for reversible fertility-compromising factors, and cross-trimester monitoring." This confirms that natural pregnancy is safe and feasible for patients in cancer remission, with multi-disciplinary collaboration and rigorous monitoring. The absence of postpartum neoplasm recurrence and abnormalities in offspring provides a practical paradigm for fertility management in patients with MPNs.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 mutation
    |
    leuprolide acetate for depot suspension
    29d
    OPTIMA-YOUNG: Optimising Adjuvant Chemotherapy Prescription in Young Patients With Hormone-dependent Breast Cancer Using Genomic Tests (clinicaltrials.gov)
    P3, N=3380, Not yet recruiting, UNICANCER
    Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 amplification • HER-2 negative • HER-2 expression
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    |
    paclitaxel • docetaxel • tamoxifen • doxorubicin hydrochloride • cyclophosphamide • letrozole • epirubicin • anastrozole • exemestane • triptorelin • goserelin acetate • leuprolide acetate for depot suspension
    1m
    Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate Cancer (clinicaltrials.gov)
    P2, N=40, Recruiting, Icahn School of Medicine at Mount Sinai | Not yet recruiting --> Recruiting | Initiation date: Jun 2025 --> Mar 2026
    Enrollment open • Trial initiation date
    |
    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay • Decipher Prostate Cancer Test
    |
    Keytruda (pembrolizumab) • Eligard (leuprolide acetate) • Nubeqa (darolutamide) • leuprolide acetate for depot suspension