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| Name | Class |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | INDUSTRY |
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To evaluate the efficacy and safety of rezvilutamide in combination with androgen deprivation therapy(ADT) and standard salvage radiation therapy(SRT) or rezvilutamide in combination with ADT in prostate cancer patients with biochemical recurrence of prostate-specific antigen(PSA) persistence after radical prostatectomy(RP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rezvilutamide +ADT+ SRT | Experimental | Rezvilutamide along with ADT for 6 cycles (28 days for each cycle) in combination with salvage radiation therapy (SRT) according to standard of care |
|
| Rezvilutamide +ADT | Experimental | Rezvilutamide along with ADT for 12 cycles (28 days for each cycle) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rezvilutamide | Drug | Specifications of 80 mg; orally, once a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 2-year biochemical progression-free survival | For arm 1, biochemical progression is defined as a confirmed prostate specific antigen (PSA) greater than (>) 0.2 nanogram per milliliter (ng/ml) | 24 months |
| 3-year biochemical progression-free survival | For arm 2, biochemical progression is defined as a confirmed PSA greater than (>) 0.2 ng/ml( the time interval should be over 2 weeks) | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| biochemical progression-free survival | Time from entry to biochemical progression or death due to any cause. | 36 months |
| progression-free survival (PFS) | Time from entry to biochemical progression or radiologically confirmed progressive disease or death due to any cause. |
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Main Inclusion Criteria:
Age ≥ 40 years, male.
Patients with histologically-confirmed diagnosis of prostate adenocarcinoma.
pathologically node-negative (pN0) or pathologically node cannot be assessed (pNx);
Patients with PSA < 0.1ng/ml within 8 weeks after radical prostatectomy (RP) and maintained for at least 6 months;
Biochemical recurrence (two consecutive rises in PSA with absolute values > 0.2ng/ml, the time interval ≥ 2 weeks apart ) and no local recurrence or distant metastatic lesions on conventional imaging (bone scan and CT/MRI scan);
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
Estimated life expectancy >10 year;
Adequate laboratory parameters
Patients able to comply with the protocol. Arm 1 subjects are proposed to receive salvage radiation therapy, while arm 2 subjects are not suitable for or refuse radiation therapy.
Signed informed consent.
Main Exclusion Criteria:
Prior hormonal therapy (antiandrogens or gonadotropin releasing hormone) or prior radiotherapy to pelvic .
Postoperative biochemical recurrence with PSA > 2 ng/ml.
Postoperative pathology containing neuro-endocrine differentiation or small cell features.
Prior malignancy other than prostate cancer in the past three years.
History of any of the following:
Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongqian Guo, phD | Contact | +86-13605171690 | dr.ghq@nju.edu.cn | |
| Shun Zhang, MD | Contact | +86-15050589789 | explorershun@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Chief physician of Department of Urology | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Recruiting | Nanjing | Jiangsu | 210000 | China |
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| Androgen deprivation therapy (ADT) | Drug | Androgen deprivation therapy (ADT), the ADT used by each subject will be determined by the investigator, and the dose and frequency of administration will be consistent with the prescription information |
|
| SRT | Radiation | SRT according to standard of care (66.6-72 grays will be delivered to the bed of prostate ,~50.4 grays to the pelvis if needed) |
|
| 36 months |
| metastasis-free survival (MFS) | Time from entry to radiologically confirmed metastasis disease or death due to any cause. | 36 months |
| Quality of life as determined by FACT-P scores | Quality of life as determined by Functional Assessment of Cancer Therapy-Prostate (FACT-P) scores | At baseline, 3 months, 6 months, every 3 months up to 3 years |
| Quality of life as determined by EPIC-26 questionnaire | Quality of life as determined by Expanded Prostate Cancer Index Composite-26 (EPIC-26) questionnaire | At baseline, 3 months, 6 months, every 3 months up to 3 years |
| Number of Adverse Events | Number of Adverse Events | 36 months |
| Duration of testosterone recovery | Duration of testosterone recovery | 36 months |
| Time to testosterone recovery to >50 ng/dl | Time to testosterone recovery to >50 ng/dl | 36 months |
| Time to testosterone recovery to >300 ng/dl | Time to testosterone recovery to >300 ng/dl | 36 months |
| JiangSu Cancer Hospital | Not yet recruiting | Nanjing | Jiangsu | China |
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000726 | Androgen Antagonists |
| ID | Term |
|---|---|
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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