A Phase 3 Comparative Study of TAP-144-SR(6M) in Prostate Cancer Patients Previously Treated With Hormonal Therapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: TAP-144-SR(6M); TAP-144-SR(3M)
Intervention MeSH terms: Leuprolide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 160.0
Sex: Male
Minimum age: 20 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate hormone dynamics, pharmacokinetics, safety, and
      efficacy of TAP-144-SR(6M) against TAP-144-SR(3M) in prostate cancer patients previously
      treated with hormonal therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The participant has histopathologically confirmed prostate cancer in Japanese.

          2. The participant has prostate cancer in the clinical stages of T1b-T4, N-any and M-any
             by TNM classification on clinical diagnosis at the time of diagnosis.

          3. The participant has ECOG performance status of grades 0, 1, or 2 at screening.

          4. The participant with PSA level which has not increased 25 % or greater and 2 ng/mL or
             more from the nadir at the measurement points 4 weeks or longer apart within the
             screening period of 12 weeks.

          5. Patients who receive the marketed product for 3 months (LEUPLIN SR FOR INJECTION KIT
             11.25) at screening

          6. Patients who have received the marketed products, TAP-144-SR (1M) and TAP-144-SR (3M),
             for 24-96 weeks in total at the scheduled starting date of the study drug, but not
             including administration period treated as neoadjuvant therapy for prostatectomy
             and/or radiation therapy

          7. Patients who have continued the nonsteroidal antiandrogen for longer than 12 weeks at
             the scheduled starting date of the study drug, if a nonsteroidal antiandrogen is
             concomitantly administered

          8. The participant with a serum testosterone level at screening < 100ng/dL

          9. The participant meets the following criteria of renal, bone-marrow and hepatic
             functions on the laboratory test results at screening:

        （1） Renal function: serum creatinine level< 1.5 times the upper limit of normal (ULN) （2）
        Bone-marrow function: white blood count ≥ 3,500/ mm3, platelet count ≥ 100,000/L,
        hemoglobin ≥ 10.0g/dL （3） Hepatic function: AST(GOT), ALT(GPT), ALP and total bilirubin ≤
        2.5 times the ULN 10. The participant's life expectancy is at least 24 months at informed
        consent.

        Exclusion Criteria:

          1. The participant has active multiple primary cancers, (synchronous multiple primary
             cancer or metachronous multiple primary cancer with the disease-free survival ≤ 5
             years)

          2. The participant has received surgical castration.

          3. The participant has ever received LHRH agonists other than commercially available
             1-month or 3-month depot of leuprolide acetate.

          4. The participant has ever received LHRH antagonists.

          5. Patients who have previously received estrogen preparations or corticosteroids for
             prostate cancer

          6. Patients who have previously received chemotherapy for prostate cancer

          7. Patients who are receiving or received the marketed product for 3 months (LEUPLIN SR
             FOR INJECTION KIT 11.25) or the marketed products for 1 month (LEUPLIN FOR INJECTION
             3.75 and KIT 3.75) as an adjuvant therapy after prostatectomy and/or radiotherapy

          8. Patients who are receiving or received the marketed product for 3 months (LEUPLIN SR
             FOR INJECTION KIT 11.25) for intermittent androgen deprivation therapy

          9. Patients who received the following drugs within 24 weeks (168 days) after starting
             the study drug: Steroidal antiandrogens, type II 5α-reductase inhibitors

         10. The participant received any of the following within 16 weeks (112 days) prior to
             study enrollment:

        （1） Radiotherapy. As for I-125 brachytherapy, within 35 weeks (245 days) prior to study
        enrollment.

        （2） Prostatectomy （3） Experimental therapy including high-intensity focused ultrasound
        therapy (HIFU), immunotherapy, and gene therapy 11. Patients who received the following
        drugs within 4 weeks (28 days) before starting the study drug: Testosterones,
        ketoconazole（except for external preparations）, spironolactone, corticosteroids (excluding
        their inhalants and external preparations), and Chinese medicines and dietary supplements
        containing saw palmetto 12. Patients whose QTcF interval exceeded 460 msec on the 12-lead
        electrocardiogram at screening 13. The participant has a history of hypersensitivity to
        synthetic LHRH, LHRH derivative or any component of the study drug.

        14. The participant has central nervous system metastasis which requires treatment or which
        is symptomatic.

        15. The participant already has a history or has a complication or may have renal disorder
        caused by spinal cord compression or ureteric obstruction.

        16. The participant has a history of serious drug allergic reaction/hypersensitivity 17.
        The participant has a history of, or has been diagnosed with thromboembolism including
        myocardial infarction, cerebral infarction, venous thrombosis, and pulmonary embolism, or
        cardiac failure