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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 SRT 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 |
|
| ADT+ SRT | Other | ADT for 6 cycles (28 days for each cycle) in combination with salvage radiation therapy (SRT) according to standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rezvilutamide | Drug | Specifications of 80 mg; orally, once a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3-year biochemical progression-free survival | biochemical progression is defined as a confirmed prostate specific antigen (PSA) greater than (>) 0.2 nanogram per milliliter (ng/ml) ( the time interval should be over 2 weeks) | 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival (PFS) | Time from entry to biochemical progression or radiologically confirmed progressive disease or death due to any cause | 48 months |
| metastasis-free survival (MFS) |
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Inclusion Criteria:
1. ≥40 years old, male;
2. Postoperative pathology showed prostate adenocarcinoma;
3. Postoperative pathological stage pN0 or pNx;
4. PSA decline < 0.1ng/ml within 8 weeks after radical prostate cancer surgery for at least 6 months
5. Biochemical recurrence (PSA rose twice in a row, with an interval of ≥2 weeks and absolute value > 0.2ng/ml), and traditional imaging (bone scan and CT/MRI scan) did not show local recurrence and distant metastasis.
6. Have one or more of the following risk factors:
7. ECOG status is 0-1;
8. Life expectancy greater than 10 years;
9. Adequate hematological and organ function tests within 4 weeks prior to the first study treatment, as defined below:
10. The subject is willing and understands to sign the informed consent and is able to comply with the agreement.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongqian Guo, phD | Contact | 13605171690 | dr.ghq@nju.edu.cn | |
| Shun Zhang, MD | Contact | 15050589789 | explorershun@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University | 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) |
|
Time from entry to radiologically confirmed metastasis disease or death due to any cause.
| 48 months |
| percentage of undetectable PSA | percentage of undetectable PSA is defined as the proportion of subjects with a PSA level ≤ 0.1 ng/mL after enrollment | 48 months |
| ctDNA-positive rate | ctDNA-positive rate was defined as the number of ctDNA subjects detected in the total enrolled population | 48 months |
| ctDNA clearance rate | Defined as the number of patients who were ctDNA-positive at enrollment to ctDNA-negative after treatment as a proportion of ctDNA-positive patients enrolled | 48 months |
| Adverse Events | According to NCI-CTCAE v5.0 | 48 months |
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Recruiting | Nanjing | Jiangsu | 210000 | 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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