Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
High risk prostate cancer (PCa) had worse outcomes on radical treatment results, short-time oncological results, even cancer-specific survival, than those low or mediate risk PCa. Neoadjuvant treatment before radical prostatectomy had been proven to get some benefits on peri-operation results, especially on reduction of tumor volume and minimization of biochemical recurrence. This study will evaluate the efficacy and safety of androgen deprivation therapy (ADT) with abiraterone in neoadjuvant therapy for surgically resectable high-risk or very high-risk PCa.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADT with Abiraterone and prednisone | Experimental | All subjects in this arm will receive luteinizing hormone releasing hormone analogue (LHRHa) plus abiraterone acetate and prednisone, as per standard of care. Goserelin 10.8 mg will be used once per 12 weeks. Abiraterone acetate will be administered orally as 1000 mg once daily along with 5 mg of oral prednisone once per day. Subjects will continue to take abiraterone acetate and prednisone for 24 weeks before robotic assisted radical prostatectomy |
|
| ADT alone | Experimental | All subjects in this arm will receive LHRHa alone for 24 weeks before receiving robotic assisted radical prostatectomy. Goserelin 10.8 mg will be administered once per 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abiraterone Acetate | Drug | 1000 mg orally daily for 24 weeks before robotic assisted radical prostatectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Complete Response Rate | The proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy | up to 8 months |
| Proportion of Subjects With Minimal Residual Disease | The proportion of subjects that have residual tumors with maximum diameter of 5 mm or less after radical prostatectomy | up to 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Stage Degradation | Clinical or pathological stage degradation after neoadjuvant therapy | up to 8 months |
| Rate of Positive Surgical Margins | The proportion of subjects with positive surgical margins after radical prostatectomy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patients with mental illness, mental disability or inability to give informed consent are not eligible.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hongqian Guo, MD | Nanjing Drum Tower Hospital, affiliated to medical school of Nanjing University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University | Nanjing | Jiangsu | 210000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37435500 | Derived | Zhuang J, Wang Y, Zhang S, Fu Y, Huang H, Lyu X, Zhang S, Marra G, Xu L, Qiu X, Guo H. Androgen deprivation therapy plus abiraterone or docetaxel as neoadjuvant therapy for very-high-risk prostate cancer: a pooled analysis of two phase II trials. Front Pharmacol. 2023 Jun 26;14:1217303. doi: 10.3389/fphar.2023.1217303. eCollection 2023. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069501 | Abiraterone Acetate |
| D011241 | Prednisone |
| D017273 | Goserelin |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Prednisone | Drug | 5 mg oral low dose prednisone, once daily |
|
| Goserelin 10.8 mg | Drug | 10.8 mg goserelin hypodermic once per 12 weeks |
|
| up to 8 months |
| Rate of Complete Serum Remission | The proportion of subjects whose PSA is less than or equal to 0.2 ng/ml after 6 months of treatment | up to 6 months |
| Proportion of subjects without PSA progression | The proportion of subjects whose PSA has never gone below 1 ng/ml or who receive any radiotherapy or systemic treatment after radical prostatectomy | 24 months |
| Imaging Response Rate | The proportion of subjects whose primary tumor is in complete remission on imaging or residual tumor's maximum diameter is less than 0.5cm | up to 8 months |
| Recovery time of urinary continence (day) | The recovery time of urinary continence (day) after radical prostatectomy, defined as 0 pad/day. | 12 month |
| biochemical recurrence-free survival (bRFS) | biochemical recurrence-free survival (bRFS) defined as time to PSA ≥ 0.2 ng/ml after radical prostatectomy. | 3 years |
| metastasis-free survival (MFS) | time from date of randomization to date of evidence of systemic disease on bone scan or cross-sectional imaging. | 5 years |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D011083 |
| Polycyclic Compounds |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |