A Study of Neoadjuvant Hormone Therapy in Patient With Advanced Prostate Cancer Undergoing Radical Prostatectomy.
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|ClinicalTrials.gov Identifier: NCT03971110|
Recruitment Status : Not yet recruiting
First Posted : June 3, 2019
Last Update Posted : June 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Advanced Prostate Cancer||Drug: Zoladex and Casodex||Phase 4|
Neoadjuvant hormonal treatment (NHT) for clinically localised prostate cancer consists of complete androgen blockade (CAB) preceding either radiotherapy or surgery. The rational for this approach is based on the assumption that NHT will reduce both the tumour and normal prostatic tissue volume, and induce cancer regression by the mechanism of apoptosis .
Most randomized clinical trials show that NHT reduces the incidence of positive surgical margins after radical prostatectomy and apparently determines tumour downstaging, however no advantage has been documented in terms of biochemical disease progression [for example, time to prostate specific antigen (PSA) increase] between treated and untreated patients [2-8]. Because of relatively low biological aggressiveness of prostatic carcinoma, many patients will need to be followed for a considerable time before drawing significant conclusions on the effects of NHT on survival [2,4,7,10]. A large sample of 393 radical prostatectomy specimens were evaluated in 3 treatment groups, which were immediate surgery, 12 weeks of NHT (Zoladex and Casodex), and 24 weeks of NHT. Patients included clinical stage B (T2a and T2b) and stage C (T3a and T3b). Systemic hormonal treatment, whether 12 weeks or 24 weeks of NHT, is able to "downstage" the primary tumour and decrease the positive margin rate before definitive localised treatment .
Currently treatment of patients with oligometastatic prostate cancer is undergoing dramatic changes . The local treatment of the primary tumour might provide a survival benefit to men with metastatic and lymph node-positive disease. Similar observations have been made in treatment of metastatic lesions with life-prolonging, rather than palliative intent [13-17].
This study is proposed primarily to observe the efficacy and safety of 24-week NHT (Zoladex and Casodex) in patients with locally advanced or oligometastatic prostate cancer. Progression status and survival will be followed-up for up to 2 years after NHT.
This is a multi-centre, single-arm and prospective study to explore the efficacy and safety of neoadjuvant hormone therapy (NHT) for advanced prostate cancer patients undergoing radical prostatectomy (RP). A total of 104 subjects with locally advanced and oligometastatic prostate cancer at clinical stage of T3 and T4 will be enrolled at almost 20 centres in China.
The eligible subjects will receive Casodex 50 mg orally per day in combination with Zoladex 10.8 mg implant subcutaneously every 12 weeks as neoadjuvant therapy for 24 weeks, and then will be assessed for resectability of the primary tumour. The subjects will undergo a RP [RALP (robot-assisted laparoscopic prostatectomy), laparoscopic RP or RRP (radical retropubic prostatectomy)] plus eLND thereafter if the primary tumour is assessed as resectable. Surgical margin status and involvement of bilateral pelvic lymph nodes will be evaluated. Subjects will be prescribed post-surgical treatment such as continuous ADT and metastasis-directed therapy upon investigator's discretion and be followed-up for up to 2 years.
Progression free survival (PFS) and overall survival (OS) will be collected during this study.
For the subjects with unresectable primary tumour after NHT, PFS and OS will also be collected in the follow-up for up to 2 years after 24 weeks of CAB.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||104 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-centre, Single-arm, Prospective Study to Assess Efficacy and Safety of Neoadjuvant Hormone Therapy Using Zoladex (Goserelin) and Casodex (Bicalutamide) in Patients With Advanced Prostate Cancer Undergoing Radical Prostatectomy.|
|Estimated Study Start Date :||July 31, 2019|
|Estimated Primary Completion Date :||January 10, 2022|
|Estimated Study Completion Date :||January 10, 2022|
Experimental: Zoladex and Casodex
Subjects who are diagnosed with advanced prostate cancer at clinical stage of T3 and T4 (N0 or N1, M0 or M1 with five or fewer extra-pelvic lesions) are the target population of this study. The eligible subjects will receive Casodex 50 mg orally per day in combination with Zoladex 10.8 mg implant subcutaneously as neoadjuvant therapy per 12 weeks for up to 24 weeks.
Drug: Zoladex and Casodex
The eligible subjects will receive Casodex 50 mg orally per day in combination with Zoladex 10.8 mg implant subcutaneously as neoadjuvant therapy per 12 weeks for up to 24 weeks.
- Resectability rate for primary tumour (the resectability will be assessed by central review using a digital rectal examination and confirmed by CT or MRI) [ Time Frame: at 24 week ]To assess the efficacy by resectability rate of neoadjuvant hormone therapy (NHT) in subjects with advanced prostate cancer
- Radical prostatectomy rate [ Time Frame: From baseline to 24 week ]Which will be derived using the number of patient who will conduct the radical prostatectomy at 24 week.
- The mean PSA by the end of NHT [ Time Frame: From baseline to 24 week ]which will be derived using the value of mean PSA by the end of NHT
- Percentage of positive surgical margin for primary tumour [ Time Frame: From baseline to 24 week ]Which will be derived using the number of positive surgical margin at 24 week
- Incidence of seminal vesicle invasion [ Time Frame: From baseline to 24 week. ]Which will be derived using the value of incidence of seminal vesicle invasion at 24 week
- Percentage of pathological downstaging [ Time Frame: From baseline to 24 week ]Which will be derived using the number of pathological downstaging at 24 week.
- surgical-related variables at 12 weeks, potent rates in erectile function at 12 weeks after surgery [ Time Frame: From 24 week to 36 week ]Which will be derived using the value of observe surgical-related variables and complications at week 36
- PFS [ Time Frame: From baseline to the end of study ]Which will be derived using the number of PFS at the end of study
- AEs/SAEs [ Time Frame: From baseline to 28 week ]To evaluate the safety of NHT using goserelin and bicalutamide
- PSA change from baseline [ Time Frame: From baseline to 24 week ]Which will be derived using the value of PSA at the baseline.
- Involvement of bilateral pelvic lymph nodes [ Time Frame: From baseline to 24 week ]Which will be derived using the value of involvement of bilateral pelvic lymph nodes at 24 week.
- OS [ Time Frame: From baseline to the end of study ]Which will be derived using the number of OS at the end of study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03971110
|Contact: AstraZeneca Clinical Study Information Centerfirstname.lastname@example.org|
|The First Affilliated Hospital of Anhui Medical University||Not yet recruiting|
|Hefei, Anhui, China|
|The Second Hospital of Hebei Medical Univeristy||Not yet recruiting|
|Shijiazhuang, Hebei, China|
|The First Affiliated Hospital of Zhengzhou University||Not yet recruiting|
|Zhengzhou, Henan, China|
|Hunan Cancer Hospital||Not yet recruiting|
|Changsha, Hunan, China|
|Principal Investigator: Weiqing Han|
|The First Hospital of China Medical University||Not yet recruiting|
|Shenyang, Liaoning, China|
|Principal Investigator: Chuize Kong|
|The FirstAffiliated Hospital of Xi'an Jiaotong University||Not yet recruiting|
|Xi'an, Shanxi, China|
|Sir Run Run Shaw Hospital, Zhejiang University School of Medicine||Not yet recruiting|
|Hangzhou, Zhejiang, China|
|Zhejiang Provincial People's Hospital||Not yet recruiting|
|Hangzhou, Zhejiang, China|
|Peking University First Hospital||Not yet recruiting|
|Principal Investigator: Liqun Zhou|
|The Second Xiangya Hospital of Central South University||Not yet recruiting|
|West China Hospital, Sichuan University||Not yet recruiting|
|The First Affiliated Hospital, Sun Yat-Sen University||Not yet recruiting|
|The Third Affilliated Hospital, Sun Yat-Sen University||Not yet recruiting|
|Fudan University Shanghai Cancer Center||Not yet recruiting|
|The First Affiliated Hospital of Xinjiang Medical University||Not yet recruiting|
|Principal Investigator:||Xin Gao||The Third Affiliated Hospital, SUN YAT-SEN University|