Prostate Cancer
Conditions
Brief 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.
Interventions
DRUGTAP-144-SR(6M)
DRUGTAP-144-SR(3M)
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Rate of Suppression of Serum Testosterone to Castrate Level | From the start of study drug administration through Week 48 | Comparison of the proportion of patients maintained at castration level (≤100 ng/dL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Course of Changes in Serum Luteinizing Hormone (LH) | From baseline to Week 48 | — |
| Time Course of Changes in Serum Follicle-stimulating Hormone (FSH) | From baseline to Week 48 | — |
| Time Course of Change Rate in Serum PSA (FAS) | From baseline to Week 48 | Evaluation according to the Criteria for therapeutic effect from the General Rule for Clinical Pathological Studies on Prostate Cancer, 4th edition (determination of therapeutic effect by prostate-specific antigen \[PSA\]) |
| The Maximum Rate of Change in PSA Suppression (FAS) | From baseline to Week 48 | Evaluation according to the Criteria for therapeutic effect from the General Rule for Clinical Pathological Studies on Prostate Cancer, 4th edition (determination of therapeutic effect by PSA) |
| Time Course of Changes in Serum Testosterone | From baseline to Week 48 | — |
| Soft Tissue Response | At week 48 | Assessment in accordance with the criteria for therapeutic effect from the General Rule for Clinical Pathological Studies on Prostate Cancer, 4th edition. Soft tissue response was evaluated in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Bone Lesion Response | At Week 48 | Partially revised assessment based on the criteria for therapeutic effect from the General Rule for Clinical and Pathological Studies on Prostate Canter, 4th edition. Response is measured using bone scintigraphy. Increase in new (2 or more) bone lesion is considered as progression |
| Serum Unchanged TAP-144 Level | From baseline to Week 48 | — |
| 12-lead ECG | At 1 hour, week 24, and week 48 after administration | — |
| Percentage of Participants With Progression by PSA (FAS) | From baseline to Week 48 | Evaluation according to the Criteria for therapeutic effect from the General Rule for Clinical Pathological Studies on Prostate Cancer, 4th edition (determination of therapeutic effect by PSA) |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the study at 23 investigative sites in Japan from 11 April 2012 to 04 April 2014.
Pre-assignment details
Prostate cancer patients previously treated with hormonal therapy were enrolled in 1 of 2 treatment groups. Two patients withdrew from the period between randomization and starting study drugs (1 in TAP-144-SR(6M) arm and 1 in TAP-144-SR(3M) arm).
Participants by arm
| Arm | Count |
|---|---|
| TAP-144-SR(6M) TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks. | 82 |
| TAP-144-SR(3M) TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks. | 80 |
| Total | 162 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 3 |
| Overall Study | Did Not Receive Study Drug | 1 | 1 |
| Overall Study | High Prostate specific antigen | 2 | 1 |
| Overall Study | Major Protocol Deviation | 1 | 1 |
Baseline characteristics
| Characteristic | TAP-144-SR(3M) | Total | TAP-144-SR(6M) |
|---|---|---|---|
| Age, Continuous | 72.6 Years STANDARD_DEVIATION 6.49 | 73.0 Years STANDARD_DEVIATION 6.39 | 73.3 Years STANDARD_DEVIATION 6.32 |
| Body Mass Index (BMI) | 24.32 kg/m^2 STANDARD_DEVIATION 2.769 | 23.96 kg/m^2 STANDARD_DEVIATION 2.764 | 23.61 kg/m^2 STANDARD_DEVIATION 2.731 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 0 | 71 Participants | 144 Participants | 73 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 1 | 7 Participants | 14 Participants | 7 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 2 | 1 Participants | 2 Participants | 1 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 3 | 0 Participants | 0 Participants | 0 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 4 | 0 Participants | 0 Participants | 0 Participants |
| Gleason Score 10 | 0 Participants | 3 Participants | 3 Participants 3.7 |
| Gleason Score 2 | 0 Participants 0 | 0 Participants | 0 Participants 0 |
| Gleason Score 3 | 0 Participants 0 | 0 Participants | 0 Participants 0 |
| Gleason Score 4 | 0 Participants 0 | 0 Participants | 0 Participants 0 |
| Gleason Score 5 | 2 Participants 2.5 | 4 Participants | 2 Participants 2.4 |
| Gleason Score 6 | 7 Participants 8.8 | 15 Participants | 8 Participants 9.8 |
| Gleason Score 7 | 29 Participants 36.3 | 64 Participants | 35 Participants 42.7 |
| Gleason Score 8 | 21 Participants 26.3 | 35 Participants | 14 Participants 17.1 |
| Gleason Score 9 | 21 Participants 26.3 | 41 Participants | 20 Participants 24.4 |
| Period between date of first dianosis and date of informed consent | 1.748 Years STANDARD_DEVIATION 2.041 | 1.700 Years STANDARD_DEVIATION 2.0583 | 1.653 Years STANDARD_DEVIATION 2.0866 |
| Period between first dose dates of leuproride acetate (over-the-counter) and the study drug | 46.595 Weeks STANDARD_DEVIATION 20.8584 | 46.460 Weeks STANDARD_DEVIATION 20.4056 | 46.328 Weeks STANDARD_DEVIATION 20.0833 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 80 Participants | 162 Participants | 82 Participants |
| TNM classification at diagnosis: M M0 | 62 participants | 125 participants | 63 participants |
| TNM classification at diagnosis: M M1 | 17 participants | 36 participants | 19 participants |
| TNM classification at diagnosis: M Unknown | 0 participants | 0 participants | 0 participants |
| TNM classification at diagnosis: N N0 | 62 Participant | 131 Participant | 69 Participant |
| TNM classification at diagnosis: N N1 | 17 Participant | 30 Participant | 13 Participant |
| TNM classification at diagnosis: N NX | 0 Participant | 0 Participant | 0 Participant |
| TNM classification at diagnosis: N Unknown | 0 Participant | 0 Participant | 0 Participant |
| Tumor-node-metastasis (TNM) classification at diagnosis: T T0 | 0 Participants 0 | 0 Participants | 0 Participants 0 |
| Tumor-node-metastasis (TNM) classification at diagnosis: T T1 | 16 Participants 20.3 | 33 Participants | 17 Participants 20.7 |
| Tumor-node-metastasis (TNM) classification at diagnosis: T T2 | 24 Participants 30.4 | 56 Participants | 32 Participants 39 |
| Tumor-node-metastasis (TNM) classification at diagnosis: T T3 | 33 Participants 41.8 | 62 Participants | 29 Participants 35.4 |
| Tumor-node-metastasis (TNM) classification at diagnosis: T T4 | 6 Participants 7.6 | 10 Participants | 4 Participants 4.9 |
| Tumor-node-metastasis (TNM) classification at diagnosis: T TX | 0 Participants 0 | 0 Participants | 0 Participants 0 |
| Tumor-node-metastasis (TNM) classification at diagnosis: T Unknown | 0 Participants 0 | 0 Participants | 0 Participants 0 |
| Weight | 65.83 kg STANDARD_DEVIATION 8.098 | 64.92 kg STANDARD_DEVIATION 8.424 | 64.03 kg STANDARD_DEVIATION 8.689 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 74 / 81 | 71 / 79 |
| serious Total, serious adverse events | 10 / 81 | 8 / 79 |
Outcome results
Primary
The Rate of Suppression of Serum Testosterone to Castrate Level
Comparison of the proportion of patients maintained at castration level (≤100 ng/dL)
Time frame: From the start of study drug administration through Week 48
Population: Full analysis set participants (all randomized participants who received at least 1 dose of study drug) was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAP-144-SR(6M) | The Rate of Suppression of Serum Testosterone to Castrate Level | Number of participants maintained | 81 Participants |
| TAP-144-SR(6M) | The Rate of Suppression of Serum Testosterone to Castrate Level | Number of participants who did not maintain | 0 Participants |
| TAP-144-SR(3M) | The Rate of Suppression of Serum Testosterone to Castrate Level | Number of participants maintained | 78 Participants |
| TAP-144-SR(3M) | The Rate of Suppression of Serum Testosterone to Castrate Level | Number of participants who did not maintain | 1 Participants |
Secondary
12-lead ECG
Time frame: At 1 hour, week 24, and week 48 after administration
Population: Safety evaluation was conducted in the safety analysis set (SAS), which includes all 160 patients who received the study drug \[TAP-144-SR (\&M) group: 81 patients, TAP-144-SR (3M) group: 79 patients
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAP-144-SR(6M) | 12-lead ECG | QTcF interval measurement at Week 24 | 425.0 msec | Standard Deviation 20.01 |
| TAP-144-SR(6M) | 12-lead ECG | QTcF interval measurement at Basline | 429.0 msec | Standard Deviation 15.75 |
| TAP-144-SR(6M) | 12-lead ECG | QTcF interval measurement at Week 48 | 428.1 msec | Standard Deviation 16.42 |
| TAP-144-SR(6M) | 12-lead ECG | QTcF interval measurement at 1 hour | 422.2 msec | Standard Deviation 20.8 |
| TAP-144-SR(3M) | 12-lead ECG | QTcF interval measurement at Week 48 | 431.7 msec | Standard Deviation 16.05 |
| TAP-144-SR(3M) | 12-lead ECG | QTcF interval measurement at Basline | 436.2 msec | Standard Deviation 15.63 |
| TAP-144-SR(3M) | 12-lead ECG | QTcF interval measurement at Week 24 | 433.4 msec | Standard Deviation 18.91 |
| TAP-144-SR(3M) | 12-lead ECG | QTcF interval measurement at 1 hour | 432.2 msec | Standard Deviation 21.93 |
Secondary
Bone Lesion Response
Partially revised assessment based on the criteria for therapeutic effect from the General Rule for Clinical and Pathological Studies on Prostate Canter, 4th edition. Response is measured using bone scintigraphy. Increase in new (2 or more) bone lesion is considered as progression
Time frame: At Week 48
Population: Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAP-144-SR(6M) | Bone Lesion Response | Presence of disesase progression: New lesions ≥ 2 | 1.3 Percentage of participants |
| TAP-144-SR(6M) | Bone Lesion Response | Presence of disesase progression: New lesions < 1 | 98.7 Percentage of participants |
| TAP-144-SR(3M) | Bone Lesion Response | Presence of disesase progression: New lesions ≥ 2 | 1.3 Percentage of participants |
| TAP-144-SR(3M) | Bone Lesion Response | Presence of disesase progression: New lesions < 1 | 98.7 Percentage of participants |
Secondary
Percentage of Participants With Progression by PSA (FAS)
Evaluation according to the Criteria for therapeutic effect from the General Rule for Clinical Pathological Studies on Prostate Cancer, 4th edition (determination of therapeutic effect by PSA)
Time frame: From baseline to Week 48
Population: Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAP-144-SR(6M) | Percentage of Participants With Progression by PSA (FAS) | Presence of disesase progression: Yes | 7.5 percentage of participants |
| TAP-144-SR(6M) | Percentage of Participants With Progression by PSA (FAS) | Presence of disesase progression: No | 6.5 percentage of participants |
| TAP-144-SR(3M) | Percentage of Participants With Progression by PSA (FAS) | Presence of disesase progression: Yes | 92.5 percentage of participants |
| TAP-144-SR(3M) | Percentage of Participants With Progression by PSA (FAS) | Presence of disesase progression: No | 93.5 percentage of participants |
Secondary
Serum Unchanged TAP-144 Level
Time frame: From baseline to Week 48
Population: Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAP-144-SR(6M) | Serum Unchanged TAP-144 Level | Week 1 | 0.1304 ng/dL | Standard Deviation 0.16388 |
| TAP-144-SR(6M) | Serum Unchanged TAP-144 Level | Week 25 | 0.1353 ng/dL | Standard Deviation 0.29809 |
| TAP-144-SR(6M) | Serum Unchanged TAP-144 Level | Week 12 | 0.1256 ng/dL | Standard Deviation 0.06886 |
| TAP-144-SR(6M) | Serum Unchanged TAP-144 Level | Week 26 | 0.4318 ng/dL | Standard Deviation 0.63101 |
| TAP-144-SR(6M) | Serum Unchanged TAP-144 Level | Week 4 | 0.8845 ng/dL | Standard Deviation 0.52695 |
| TAP-144-SR(6M) | Serum Unchanged TAP-144 Level | Week 28 | 0.7622 ng/dL | Standard Deviation 0.42483 |
| TAP-144-SR(6M) | Serum Unchanged TAP-144 Level | Week 16 | 0.1024 ng/dL | Standard Deviation 0.093951 |
| TAP-144-SR(6M) | Serum Unchanged TAP-144 Level | Week 32 | 0.1524 ng/dL | Standard Deviation 0.098308 |
| TAP-144-SR(6M) | Serum Unchanged TAP-144 Level | Week 2 | 0.3085 ng/dL | Standard Deviation 0.30523 |
| TAP-144-SR(6M) | Serum Unchanged TAP-144 Level | Week 36 | 0.1091 ng/dL | Standard Deviation 0.057582 |
| TAP-144-SR(6M) | Serum Unchanged TAP-144 Level | Week 20 | 0.06957 ng/dL | Standard Deviation 0.053682 |
| TAP-144-SR(6M) | Serum Unchanged TAP-144 Level | Week 40 | 0.09118 ng/dL | Standard Deviation 0.065771 |
| TAP-144-SR(6M) | Serum Unchanged TAP-144 Level | Week 8 | 0.1792 ng/dL | Standard Deviation 0.10354 |
| TAP-144-SR(6M) | Serum Unchanged TAP-144 Level | Week 44 | 0.06958 ng/dL | Standard Deviation 0.055624 |
| TAP-144-SR(6M) | Serum Unchanged TAP-144 Level | Week 24 | 0.05167 ng/dL | Standard Deviation 0.043221 |
| TAP-144-SR(6M) | Serum Unchanged TAP-144 Level | Week 48 | 0.04596 ng/dL | Standard Deviation 0.030006 |
| TAP-144-SR(6M) | Serum Unchanged TAP-144 Level | Baseline | 0.07113 ng/dL | Standard Deviation 0.043808 |
| TAP-144-SR(3M) | Serum Unchanged TAP-144 Level | Week 48 | 0.07945 ng/dL | Standard Deviation 0.06698 |
| TAP-144-SR(3M) | Serum Unchanged TAP-144 Level | Baseline | 0.06188 ng/dL | Standard Deviation 0.035339 |
| TAP-144-SR(3M) | Serum Unchanged TAP-144 Level | Week 1 | 0.1869 ng/dL | Standard Deviation 0.077198 |
| TAP-144-SR(3M) | Serum Unchanged TAP-144 Level | Week 2 | 0.1335 ng/dL | Standard Deviation 0.08306 |
| TAP-144-SR(3M) | Serum Unchanged TAP-144 Level | Week 4 | 0.1132 ng/dL | Standard Deviation 0.1211 |
| TAP-144-SR(3M) | Serum Unchanged TAP-144 Level | Week 8 | 0.08374 ng/dL | Standard Deviation 0.041078 |
| TAP-144-SR(3M) | Serum Unchanged TAP-144 Level | Week 12 | 0.08039 ng/dL | Standard Deviation 0.056305 |
| TAP-144-SR(3M) | Serum Unchanged TAP-144 Level | Week 16 | 0.1220 ng/dL | Standard Deviation 0.067137 |
| TAP-144-SR(3M) | Serum Unchanged TAP-144 Level | Week 20 | 0.08450 ng/dL | Standard Deviation 0.039532 |
| TAP-144-SR(3M) | Serum Unchanged TAP-144 Level | Week 24 | 0.07437 ng/dL | Standard Deviation 0.045186 |
| TAP-144-SR(3M) | Serum Unchanged TAP-144 Level | Week 25 | 0.1978 ng/dL | Standard Deviation 0.083286 |
| TAP-144-SR(3M) | Serum Unchanged TAP-144 Level | Week 26 | 0.1418 ng/dL | Standard Deviation 0.087312 |
| TAP-144-SR(3M) | Serum Unchanged TAP-144 Level | Week 28 | 0.1067 ng/dL | Standard Deviation 0.054505 |
| TAP-144-SR(3M) | Serum Unchanged TAP-144 Level | Week 32 | 0.08236 ng/dL | Standard Deviation 0.04618 |
| TAP-144-SR(3M) | Serum Unchanged TAP-144 Level | Week 36 | 0.08407 ng/dL | Standard Deviation 0.075147 |
| TAP-144-SR(3M) | Serum Unchanged TAP-144 Level | Week 40 | 0.1086 ng/dL | Standard Deviation 0.051455 |
| TAP-144-SR(3M) | Serum Unchanged TAP-144 Level | Week 44 | 0.08639 ng/dL | Standard Deviation 0.051923 |
Secondary
Soft Tissue Response
Assessment in accordance with the criteria for therapeutic effect from the General Rule for Clinical Pathological Studies on Prostate Cancer, 4th edition. Soft tissue response was evaluated in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: At week 48
Population: Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAP-144-SR(6M) | Soft Tissue Response | Partial Response | 0.0 Percentage of participants |
| TAP-144-SR(6M) | Soft Tissue Response | Progressive Disease | 0.0 Percentage of participants |
| TAP-144-SR(6M) | Soft Tissue Response | Stable Disease | 13.9 Percentage of participants |
| TAP-144-SR(6M) | Soft Tissue Response | Not Evaluable | 86.1 Percentage of participants |
| TAP-144-SR(6M) | Soft Tissue Response | Complete response | 0.0 Percentage of participants |
| TAP-144-SR(3M) | Soft Tissue Response | Not Evaluable | 85.5 Percentage of participants |
| TAP-144-SR(3M) | Soft Tissue Response | Complete response | 0.0 Percentage of participants |
| TAP-144-SR(3M) | Soft Tissue Response | Partial Response | 0.0 Percentage of participants |
| TAP-144-SR(3M) | Soft Tissue Response | Stable Disease | 11.8 Percentage of participants |
| TAP-144-SR(3M) | Soft Tissue Response | Progressive Disease | 2.6 Percentage of participants |
Secondary
The Maximum Rate of Change in PSA Suppression (FAS)
Evaluation according to the Criteria for therapeutic effect from the General Rule for Clinical Pathological Studies on Prostate Cancer, 4th edition (determination of therapeutic effect by PSA)
Time frame: From baseline to Week 48
Population: Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAP-144-SR(6M) | The Maximum Rate of Change in PSA Suppression (FAS) | -86.225 percent change |
| TAP-144-SR(3M) | The Maximum Rate of Change in PSA Suppression (FAS) | -67.030 percent change |
Secondary
Time Course of Change Rate in Serum PSA (FAS)
Evaluation according to the Criteria for therapeutic effect from the General Rule for Clinical Pathological Studies on Prostate Cancer, 4th edition (determination of therapeutic effect by prostate-specific antigen \[PSA\])
Time frame: From baseline to Week 48
Population: Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TAP-144-SR(6M) | Time Course of Change Rate in Serum PSA (FAS) | Week 28 | -56.705 percent change |
| TAP-144-SR(6M) | Time Course of Change Rate in Serum PSA (FAS) | Week 16 | -19.720 percent change |
| TAP-144-SR(6M) | Time Course of Change Rate in Serum PSA (FAS) | Week 32 | -57.690 percent change |
| TAP-144-SR(6M) | Time Course of Change Rate in Serum PSA (FAS) | Week 8 | -14.255 percent change |
| TAP-144-SR(6M) | Time Course of Change Rate in Serum PSA (FAS) | Week 36 | -60.710 percent change |
| TAP-144-SR(6M) | Time Course of Change Rate in Serum PSA (FAS) | Week 20 | -44.740 percent change |
| TAP-144-SR(6M) | Time Course of Change Rate in Serum PSA (FAS) | Week 40 | -80.610 percent change |
| TAP-144-SR(6M) | Time Course of Change Rate in Serum PSA (FAS) | Week 12 | -20.810 percent change |
| TAP-144-SR(6M) | Time Course of Change Rate in Serum PSA (FAS) | Week44 | -74.105 percent change |
| TAP-144-SR(6M) | Time Course of Change Rate in Serum PSA (FAS) | Week 24 | -49.270 percent change |
| TAP-144-SR(6M) | Time Course of Change Rate in Serum PSA (FAS) | Week 48 | -72.900 percent change |
| TAP-144-SR(6M) | Time Course of Change Rate in Serum PSA (FAS) | Week 4 | -7.930 percent change |
| TAP-144-SR(3M) | Time Course of Change Rate in Serum PSA (FAS) | Week 48 | -59.400 percent change |
| TAP-144-SR(3M) | Time Course of Change Rate in Serum PSA (FAS) | Week 4 | -10.000 percent change |
| TAP-144-SR(3M) | Time Course of Change Rate in Serum PSA (FAS) | Week 12 | -21.130 percent change |
| TAP-144-SR(3M) | Time Course of Change Rate in Serum PSA (FAS) | Week 16 | -20.650 percent change |
| TAP-144-SR(3M) | Time Course of Change Rate in Serum PSA (FAS) | Week 20 | -39.970 percent change |
| TAP-144-SR(3M) | Time Course of Change Rate in Serum PSA (FAS) | Week 24 | -31.110 percent change |
| TAP-144-SR(3M) | Time Course of Change Rate in Serum PSA (FAS) | Week 28 | -45.875 percent change |
| TAP-144-SR(3M) | Time Course of Change Rate in Serum PSA (FAS) | Week 32 | -40.745 percent change |
| TAP-144-SR(3M) | Time Course of Change Rate in Serum PSA (FAS) | Week 36 | -50.520 percent change |
| TAP-144-SR(3M) | Time Course of Change Rate in Serum PSA (FAS) | Week 40 | -58.520 percent change |
| TAP-144-SR(3M) | Time Course of Change Rate in Serum PSA (FAS) | Week44 | -54.585 percent change |
| TAP-144-SR(3M) | Time Course of Change Rate in Serum PSA (FAS) | Week 8 | -15.880 percent change |
Secondary
Time Course of Changes in Serum Follicle-stimulating Hormone (FSH)
Time frame: From baseline to Week 48
Population: Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TAP-144-SR(6M) | Time Course of Changes in Serum Follicle-stimulating Hormone (FSH) | Week 48 | 5.110 mIU/mL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Follicle-stimulating Hormone (FSH) | Week 1 | 5.430 mIU/mL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Follicle-stimulating Hormone (FSH) | Week 2 | 4.890 mIU/mL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Follicle-stimulating Hormone (FSH) | Week 4 | 4.625 mIU/mL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Follicle-stimulating Hormone (FSH) | Week 8 | 5.225 mIU/mL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Follicle-stimulating Hormone (FSH) | Week 12 | 5.340 mIU/mL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Follicle-stimulating Hormone (FSH) | Week 16 | 5.300 mIU/mL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Follicle-stimulating Hormone (FSH) | Week 20 | 5.030 mIU/mL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Follicle-stimulating Hormone (FSH) | Week 24 | 4.990 mIU/mL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Follicle-stimulating Hormone (FSH) | Week 25 | 5.210 mIU/mL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Follicle-stimulating Hormone (FSH) | Week 26 | 5.010 mIU/mL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Follicle-stimulating Hormone (FSH) | Week 28 | 5.060 mIU/mL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Follicle-stimulating Hormone (FSH) | Week 32 | 5.210 mIU/mL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Follicle-stimulating Hormone (FSH) | Week 36 | 5.585 mIU/mL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Follicle-stimulating Hormone (FSH) | Week 40 | 5.100 mIU/mL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Follicle-stimulating Hormone (FSH) | Week 44 | 5.150 mIU/mL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Follicle-stimulating Hormone (FSH) | Baseline | 5.120 mIU/mL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Follicle-stimulating Hormone (FSH) | Week 36 | 4.970 mIU/mL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Follicle-stimulating Hormone (FSH) | Week 25 | 4.970 mIU/mL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Follicle-stimulating Hormone (FSH) | Week 1 | 4.810 mIU/mL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Follicle-stimulating Hormone (FSH) | Week 48 | 4.820 mIU/mL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Follicle-stimulating Hormone (FSH) | Week 2 | 4.710 mIU/mL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Follicle-stimulating Hormone (FSH) | Week 26 | 5.020 mIU/mL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Follicle-stimulating Hormone (FSH) | Week 4 | 4.950 mIU/mL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Follicle-stimulating Hormone (FSH) | Week 40 | 4.910 mIU/mL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Follicle-stimulating Hormone (FSH) | Week 8 | 5.240 mIU/mL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Follicle-stimulating Hormone (FSH) | Week 28 | 5.070 mIU/mL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Follicle-stimulating Hormone (FSH) | Week 12 | 5.110 mIU/mL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Follicle-stimulating Hormone (FSH) | Baseline | 4.780 mIU/mL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Follicle-stimulating Hormone (FSH) | Week 16 | 5.370 mIU/mL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Follicle-stimulating Hormone (FSH) | Week 32 | 5.030 mIU/mL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Follicle-stimulating Hormone (FSH) | Week 20 | 5.260 mIU/mL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Follicle-stimulating Hormone (FSH) | Week 44 | 4.990 mIU/mL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Follicle-stimulating Hormone (FSH) | Week 24 | 5.150 mIU/mL |
Secondary
Time Course of Changes in Serum Luteinizing Hormone (LH)
Time frame: From baseline to Week 48
Population: Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TAP-144-SR(6M) | Time Course of Changes in Serum Luteinizing Hormone (LH) | Week 1 | 0.160 mIU/mL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Luteinizing Hormone (LH) | Week 25 | 0.150 mIU/mL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Luteinizing Hormone (LH) | Week 12 | 0.000 mIU/mL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Luteinizing Hormone (LH) | Week 26 | 0.170 mIU/mL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Luteinizing Hormone (LH) | Week 4 | 0.120 mIU/mL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Luteinizing Hormone (LH) | Week 28 | 0.110 mIU/mL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Luteinizing Hormone (LH) | Week 16 | 0.000 mIU/mL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Luteinizing Hormone (LH) | Week 32 | 0.000 mIU/mL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Luteinizing Hormone (LH) | Week 2 | 0.180 mIU/mL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Luteinizing Hormone (LH) | Week 36 | 0.000 mIU/mL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Luteinizing Hormone (LH) | Week 20 | 0.000 mIU/mL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Luteinizing Hormone (LH) | Week 40 | 0.000 mIU/mL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Luteinizing Hormone (LH) | Week 8 | 0.000 mIU/mL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Luteinizing Hormone (LH) | Week 44 | 0.000 mIU/mL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Luteinizing Hormone (LH) | Week 24 | 0.000 mIU/mL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Luteinizing Hormone (LH) | Week 48 | 0.000 mIU/mL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Luteinizing Hormone (LH) | Baseline | 0.000 mIU/mL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Luteinizing Hormone (LH) | Week 48 | 0.000 mIU/mL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Luteinizing Hormone (LH) | Baseline | 0.000 mIU/mL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Luteinizing Hormone (LH) | Week 1 | 0.220 mIU/mL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Luteinizing Hormone (LH) | Week 2 | 0.150 mIU/mL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Luteinizing Hormone (LH) | Week 4 | 0.110 mIU/mL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Luteinizing Hormone (LH) | Week 8 | 0.000 mIU/mL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Luteinizing Hormone (LH) | Week 12 | 0.110 mIU/mL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Luteinizing Hormone (LH) | Week 16 | 0.055 mIU/mL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Luteinizing Hormone (LH) | Week 20 | 0.110 mIU/mL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Luteinizing Hormone (LH) | Week 24 | 0.000 mIU/mL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Luteinizing Hormone (LH) | Week 25 | 0.185 mIU/mL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Luteinizing Hormone (LH) | Week 26 | 0.130 mIU/mL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Luteinizing Hormone (LH) | Week 28 | 0.000 mIU/mL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Luteinizing Hormone (LH) | Week 32 | 0.000 mIU/mL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Luteinizing Hormone (LH) | Week 36 | 0.000 mIU/mL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Luteinizing Hormone (LH) | Week 40 | 0.000 mIU/mL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Luteinizing Hormone (LH) | Week 44 | 0.000 mIU/mL |
Secondary
Time Course of Changes in Serum Testosterone
Time frame: From baseline to Week 48
Population: Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TAP-144-SR(6M) | Time Course of Changes in Serum Testosterone | Week 1 | 6.0 ng/dL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Testosterone | Week 25 | 6.0 ng/dL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Testosterone | Week 12 | 7.0 ng/dL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Testosterone | Week 26 | 5.0 ng/dL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Testosterone | Week 4 | 7.0 ng/dL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Testosterone | Week 28 | 8.0 ng/dL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Testosterone | Week 16 | 7.0 ng/dL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Testosterone | Week 32 | 9.0 ng/dL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Testosterone | Week 2 | 7.0 ng/dL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Testosterone | Week 36 | 8.0 ng/dL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Testosterone | Week 20 | 8.0 ng/dL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Testosterone | Week 40 | 8.0 ng/dL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Testosterone | Week 8 | 7.5 ng/dL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Testosterone | Week 44 | 7.0 ng/dL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Testosterone | Week 24 | 7.0 ng/dL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Testosterone | Week 48 | 9.0 ng/dL |
| TAP-144-SR(6M) | Time Course of Changes in Serum Testosterone | Baseline | 8.0 ng/dL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Testosterone | Week 48 | 6.0 ng/dL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Testosterone | Baseline | 7.0 ng/dL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Testosterone | Week 1 | 7.0 ng/dL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Testosterone | Week 2 | 6.0 ng/dL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Testosterone | Week 4 | 8.0 ng/dL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Testosterone | Week 8 | 8.0 ng/dL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Testosterone | Week 12 | 8.0 ng/dL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Testosterone | Week 16 | 7.5 ng/dL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Testosterone | Week 20 | 6.0 ng/dL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Testosterone | Week 24 | 6.0 ng/dL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Testosterone | Week 25 | 5.5 ng/dL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Testosterone | Week 26 | 4.0 ng/dL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Testosterone | Week 28 | 6.0 ng/dL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Testosterone | Week 32 | 8.0 ng/dL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Testosterone | Week 36 | 7.0 ng/dL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Testosterone | Week 40 | 8.0 ng/dL |
| TAP-144-SR(3M) | Time Course of Changes in Serum Testosterone | Week 44 | 8.0 ng/dL |