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This randomized, controlled, single center clinical trial aims to evaluate the efficacy and safety of Androgen Deprivation Therapy Combined with Docetaxel for High Risk Prostate Cancer with a six-month treatment cycle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Androgen Deprivation Therapy with Docetaxel | Experimental | All subjects in this arm will receive luteinizing hormone releasing hormone analogue (LHRHa) plus docetaxel and prednisone, as per standard of care. Triptorelin pamoate (Diphereline) 15mg will be used once per 12 weeks. Docetaxel (75 mg/m2 body surface area) will be administered as intravenous drip every 3 weeks for 6 cycles. Robot assisted radical prostatectomy will be followed in 2 weeks when 24-week treatment cycle is finished. |
|
| ADT alone | Active Comparator | All subjects in this arm will receive LHRHa alone for 24 weeks before receiving robot assisted radical prostatectomy. Triptorelin Pamoate 15mg will be administered once per 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel injection | Drug | 75 mg/m2 body surface area every 3 weeks for 6 cycles before robot 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 |
| pCR or MRD rate | The proportion of patients with pCR or MRD. Pathologic complete response (pCR): defined as no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy. Minimal Residual Disease (MRD): defined as residual tumors with maximum diameter of 3 mm or less after radical prostatectomy. | up to 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Rate of Stage Degradation |
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Inclusion Criteria:
Patients must be ≥ 18 and ≤75 years of age.
All patients must have a histologically or cytologically diagnosis of prostate cancer and must be eligible for radical prostatectomy.
All patients must undergo thorough tumor staging and meet one of the following criteria:
Patients must participate voluntarily and sign an informed consent form(ICF), indicating that they understand the purpose and required procedures of the study, and are willing to participate in. Patients must be willing to obey the prohibitions and restrictions specified in the research protocol.
Exclusion Criteria:
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| 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 |
|---|---|---|---|---|---|---|
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | 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. |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D017329 | Triptorelin Pamoate |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Triptorelin Pamoate for Injectable Suspension | Drug | 15mg every 12 weeks |
|
| Prednisone Acetate Tablets | Drug | 5 mg oral low dose prednisone, once daily |
|
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. | 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 8 months |
| Operative time (min) | The operative time(min) of radical prostatectomy. | 12 month |
| Estimated blood loss (ml) | Estimated blood loss (ml) during the process of radical prostatectomy. | 12 month |
| Hospital length of stay (day) | The hospitalization time, recorded in day. | 12 month |
| Drainage duration (day) | Length of drainage duration, recorded in day. | 12 month |
| Incidence of complications (%) | The proportion of subjects who suffer from major complications. | 12 month |
| Recovery time of urinary continence (day) | The recovery time of urinary continence (day) after radical prostatectomy, defined as 0 pad/day. | 12 month |
| biochemical progression-free survival (bPFS) | Biochemical progression was defined as two consecutive rising PSA values that were above 0.2ng/ml at least one month apart, or starting adjuvant therapy after surgery including radiotherapy, ADT or anti-androgen therapy. The time for bPFS was measured from randomization to biochemical progression or death from any cause. | 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 |
| Serum complete response rate | Serum complete response rate, defined as the proportion of participants with PSA ≤ 0.1 ng/mL after 6-month neoadjuvant therapy. | after 6 month neoadjuvant therapy and before surgery |
| Rate of extracapsular extension | The proportion of patients with extracapsular extension on pathologic specimens after neoadjuvant therapy. | 12 month |
| Rate of positive lymph node | The proportion of patients with positive lymph node on pathologic specimens after neoadjuvant therapy. | 12 month |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| 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 |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |