Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Abiraterone Acetate

Prednisone

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

TQB3823 tablets + abiraterone acetate tablets + prednisone acetate tablets，28 days as a treatment cycle.

TQB3823 tablet is an inhibitor of poly ADP-ribose polymerase (PARP).

TQB3823 tablets

Abiraterone acetate tablet is an inhibitor of cytochrome P450 17（CYP17）

Abiraterone acetate tablets

Prednisone acetate tablet is a kind of glucocorticoids

prednisone acetate tablets

This is a phase Ib/II clinical study to explore the safety and efficacy of TQB3823 tablets combined with abiraterone acetate tablets and prednisone acetate tablets in patients with metastatic castration-resistant prostate cancer.

This is a two-phase, open-label Phase Ib clinical trial. The first phase plans to enroll 6-12 patients as two cohorts to explore the safety and of TQB3823 tablets combined with abiraterone and prednisone and the recommended dose of phase II of TQB3823. Subjects involved in cohort one accepts TQB3823 treatment during cycle one and then TQB3823 combined with abiraterone and prednisone from cycle two till the disease progression. The second phase plans to enroll a total of 40-60 subjects, aiming to evaluate the safety and efficacy of TQB3823 tablets combined with abiraterone and prednisone.

To Evaluate the Efficacy of TQB3823 Combined With Abiraterone and Prednisone in Metastatic Castration-resistant Prostate Cancer Patientsprednisone Acetate Tablets in Patients With Metastatic Castration-resistant Prostate Cancer

Phase Ib/II Clinical Study of TQB3823 Tablets Combined With Abiraterone Acetate Tablets and Prednisone Acetate Tablets in Patients With Metastatic Castration-resistant Prostate Cancer

The relevant adverse reactions occurred within the first cycle

The dose of TQB3823 tablet which is recommended to use during phase II clinical trial

Proportion of subjects without disease progression assessed by radiology within 12 months

rPFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause evaluated by radiological examination

Proportion of subjects without disease progression assessed by radiology within 6 months

Proportion of subjects with reduction of PSA

Percentage of participants achieving complete response (CR) and partial response (PR).

OS defined as the time from randomization until the death from any cause

Proportion of subjects with clinical benefit

The time when the participants first achieved CR or PR to disease progression or death from any cause.

Time to progression of bone disease in subjects

The time it takes for the drug's concentration in the body to drop by half

The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Reproductive Control Agents

Docetaxel

Androgens

Prolactin Release-Inhibiting Factors

Triptorelin Pamoate

Tubulin Modulators

Antimitotic Agents

Contraceptive Agents

Contraceptive Agents, Female

Contraceptive Agents, Hormonal

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.

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.

75 mg/m2 body surface area every 3 weeks for 6 cycles before robot assisted radical prostatectomy

Docetaxel injection

Triptorelin Pamoate for Injectable Suspension

5 mg oral low dose prednisone, once daily

Prednisone Acetate Tablets

Hongqian Guo, MD

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.

Androgen Deprivation Therapy Combined With Docetaxel for High Risk Prostate Cancer

A Randomized, Controlled, Single Center Clinical Trial to Evaluate the Efficacy and Safety of Neoadjuvant Therapy With Androgen Deprivation Therapy Combined With Docetaxel for High Risk and Very High Risk Prostate Cancer

The proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy.

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.

The proportion of subjects whose primary tumor is in complete remission on imaging or residual tumor's maximum diameter is less than 0.5cm.

Clinical or pathological stage degradation after neoadjuvant therapy

The proportion of subjects with positive surgical margins after radical prostatectomy.

The proportion of subjects whose PSA is less than or equal to 0.2 ng/ml after 6 months of treatment.

The operative time(min) of radical prostatectomy.

Estimated blood loss (ml) during the process of radical prostatectomy.

The hospitalization time, recorded in day.

Length of drainage duration, recorded in day.

The proportion of subjects who suffer from major complications.

The recovery time of urinary continence (day) after radical prostatectomy, defined as 0 pad/day.

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.

Time from date of randomization to date of evidence of systemic disease on bone scan or cross-sectional imaging.

Serum complete response rate, defined as the proportion of participants with PSA ≤ 0.1 ng/mL after 6-month neoadjuvant therapy.

The proportion of patients with extracapsular extension on pathologic specimens after neoadjuvant therapy.

The proportion of patients with positive lymph node on pathologic specimens after neoadjuvant therapy.

Hongqian Guo

chief physician

Leuprolide

Goserelin

After 6 cycles of first-line treatment (Androgen deprivation therapy + abiraterone acetate along with prednisone) , patients will receive robot assisted laparoscopic prostatectomy + enlarged pelvic lymph node dissection (ePLND) within 9 months of being diagnosed. The ADT+abiraterone treatment will be maintained after surgery.

Patients will be only treated with Androgen deprivation therapy + abiraterone acetate along with prednisone. Prostatectomy won't be performed.

Robot assisted laparoscopic prostatectomy + enlarged pelvic lymph node dissection will be performed.

robot assisted laparoscopic prostatectomy + enlarged pelvic lymph node dissection

1000mg(4 tablets, 250mg per tablet) daily for 6 cycles

1.Abiraterone Acetate Tablets

5 mg oral low dose prednisone taken along with Abiraterone Acetate Tablets

Hypodermic injection of Luteinizing Hormone-Releasing Hormone Analog every 4 weeks including goserelin, leuprolide, triptorelin ect.

Luteinizing Hormone-Releasing Hormone Analog

This randomized, controlled, multi-center clinical trial aims to evaluate the efficacy and safety of prostatectomy for castration-Naive oligometastatic prostate cancer

The Efficacy and Safety of Prostatectomy for Castration-Naive Oligometastatic Prostate Cancer

A Randomized, Controlled, Multi-Center Clinical Trial to Evaluate the Efficacy and Safety of Prostatectomy for Castration-Naive Oligometastatic Prostate Cancer

PSA progression is defined as elevated PSA levels(≥2ng/ml) for no less than 2 measurements at least 1 week apart.

Radiographic progression is defined as newly discovered soft tissue metastasis according to the RECIST 1.1 or at least 2 bone lesions.

The time of radiographic progression free survival

Time to the point when PSA drop to below 50% initial PSA level. Time to the point when PSA drop to below 10% initial PSA level.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
To Evaluate the Efficacy of TQB3823 Combined With Abiraterone and Prednisone in Metastatic Castration-resistant Prostate Cancer Patientsprednisone Acetate Tablets in Patients With Metastatic Castration-resistant Prostate Cancer	NCT05405439	Metastatic Cast...	TQB3823 tablets Abiraterone ace... prednisone acet...	18 Years - 85 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Androgen Deprivation Therapy Combined With Docetaxel for High Risk Prostate Cancer	NCT04869371	Neoadjuvant The...	Docetaxel injec... Triptorelin Pam... Prednisone Acet...	18 Years - 75 Years	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
To Evaluate the Efficacy of TQB3823 Combined With Abiraterone and Prednisone in Metastatic Castration-resistant Prostate Cancer Patientsprednisone Acetate Tablets in Patients With Metastatic Castration-resistant Prostate Cancer	NCT05405439	Metastatic Cast...	TQB3823 tablets Abiraterone ace... prednisone acet...	18 Years - 85 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
To Evaluate the Efficacy of TQB3823 Combined With Abiraterone and Prednisone in Metastatic Castration-resistant Prostate Cancer Patientsprednisone Acetate Tablets in Patients With Metastatic Castration-resistant Prostate Cancer	NCT05405439	Metastatic Cast...	TQB3823 tablets Abiraterone ace... prednisone acet...	18 Years - 85 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
The Efficacy and Safety of Prostatectomy for Castration-Naive Oligometastatic Prostate Cancer	NCT04992026	Prostatectomy Oligometastatic... Abiraterone	robot assisted ... 1.Abiraterone A... Prednisone Acet... Luteinizing Hor...	40 Years - 75 Years	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Spots Global Cancer Trial Database for prednisone acetate tablets