Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Immune System Diseases

Carcinoma

Prostatic Neoplasms

Hypersensitivity

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

Docetaxel

Hormones

Prednisone

Goserelin

Bicalutamide

Hormone Antagonists

Neoadjuvant chemotherapy combined with hormone therapy, Radical Prostatectomy (RP)+ extended lymph node dissection

Neoadjuvant hormonal therapy, radical Prostatectomy (RP)+ extended lymph node dissection.

Radical Prostatectomy (RP)+ extended lymph node dissection alone.

Docetaxel 75mg/m2 IV (every 3 weeks) +Prednisone 5mg BID orally + HT (Bicalutamide Tablets, 50mg QD orally; Goserelin, 3.6mg, subcutaneous injection, q28d), 4-6 cycles

Neoadjuvant chemotherapy combined with hormone therapy

HT (Bicalutamide Tablets, 50mg QD orally; Goserelin, 3.6mg, subcutaneous injection, q28d), 3-6 cycles

Neoadjuvant hormone therapy

Radical Prostatectomy (RP)+ extended lymph node dissection: Within three months after neoadjuvant treatment.

Treatment after prostatectomy: There will not have any drug treatment after surgery until disease progression.

Pelvic lymph node dissection is required to reach the level of bilateral iliac artery. If the postoperative pathology indicated positive incisional margin or pelvic lymph node metastasis, pelvic adjuvant radiotherapy should be performed within 3 months after surgery.

Radical Prostatectomy (RP)+ extended lymph node dissection

Wei Xue

Chenfei Chi

To evaluate of the value of radical prostatectomy and extended pelvic lymph node dissection in locally advanced prostate cancer after neoadjuvant hormonal therapy with or without docetaxel chemotherapy.

Using larger sample prospective randomized controlled study design, and comparing neoadjuvant HT combined with docetaxel chemotherapy to neoadjuvant HT followed by RP and extended lymph node dissection to determine whether neoadjuvant HT combined with docetaxel chemotherapy can more effectively improve biochemical progression-free survival of locally advanced prostate cancer patients.

Further analysis was performed to determine whether the treatment regimen helped to prolong the radiologic progression-free survival (rPFS) or OS in these patients.

The pathological changes of tumor before and after neoadjuvant treatment were also analyzed. To search for the important risk factors influencing the long-term prognosis of these patients, the safety characteristics of patients in different treatment groups were analyzed. Therefore, it can provide the basis for the formulation of the optimal treatment plan for locally advanced prostate cancer, prolong the survival time of patients and improve the quality of life.

Study design: Prospective，Multicenter, Open-label, Parallel group, Randomized (2:2:1) Controlled , Clinical Trial

Study group: Newly diagnosed, untreated cT3a-cT4 or any cT, cN1 in locally advanced hormone-sensitive prostate cancer.

Study group number: 475 cases, Randomized 2:2:1

Neoadjuvant Chemo-hormonal Therapy Combined With Radical Prostatectomy for Locally Advanced Prostate Cancer

A Prospective, Multicenter, Three-arm, Randomized, Controlled Study Comparing the Efficacy of Neoadjuvant Hormonal Therapy Combined With Systemic Chemotherapy (NCHT), Neoadjuvant Hormonal Therapy (NHT) and Radical Prostatectomy Only in Locally Advanced Prostate Cancer

Biochemical recurrence-free survival (bPFS): defined as the time from randomization to biochemical recurrence. The definition of biochemical recurrence is as follows: in the case of normal testosterone levels, the PSA was \>0.2 ng/ml twice for more than 4 consecutive weeks.

The ratio of patients whose consecutive postoperative PSA \<0.2ng/ml within 1-year.

The time from randomization to death due to all causes.

The time from randomization to first confirmed imaging progression or death (whichever first is counted). Imaging progression was defined as one of the following: a. Progression of soft tissue lesions as defined in the revised RECIST 1.1 (Appendix 8) found by CT or MRI. b. Confirmation of bone metastasis lesions by ECT or PET-CT examination.

The time from randomization to the time when PSA increased by 25%.

The time from treatment to the time of ECOG score progression.

RenJi Hospital

Digestive System Diseases

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Rare Diseases

Stomach Neoplasms

Breast Neoplasms

Pancreatic Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Gonadal Disorders

Stomach Diseases

Stomach Cancer

Pancreatic Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Talazoparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Patients receive talazoparib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy and blood sample collection throughout the study. Patients undergo CT scan or MRI throughout the study.

Biopsy

Biospecimen Collection

Computed Tomography

Magnetic Resonance Imaging

Site Public Contact

Thomas J. George

A P. Chen

Abdul Rafeh Naqash

A P Chen

This phase II trial studies if talazoparib works in patients with cancer that has spread to other places in the body (advanced) and has mutation(s) in deoxyribonucleic acid (DNA) damage response genes who have or have not already been treated with another PARP inhibitor. Talazoparib is an inhibitor of PARP, a protein that helps repair damaged DNA. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. All patients who take part on this study must have a gene aberration that changes how their tumors are able to repair DNA. This trial may help scientists learn whether some patients might benefit from taking different PARP inhibitors "one after the other" and learn how talazoparib works in treating patients with advanced cancer who have aberration in DNA repair genes.

PRIMARY OBJECTIVE:

I. Determine the pharmacodynamic (PD) effect of talazoparib in tumor biopsies for patients with aberrations in deoxyribonucleic acid (DNA) damage response genes who have or have not received prior PARP inhibitor treatment (separately).

SECONDARY OBJECTIVE:

I. Determine the response rate (complete response \[CR\] + partial response \[PR\]) of treatment with talazoparib in patients with aberrations in DNA damage response genes.

EXPLORATORY OBJECTIVE:

I. Investigate tumor genomic alterations potentially associated with sensitivity or acquired resistance to talazoparib.

OUTLINE:

Patients receive talazoparib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy and blood sample collection throughout the study. Patients undergo computed tomography (CT) scan or magnetic resonance imaging (MRI) throughout the study.

After completion of study treatment, patients are followed up at 30 days.

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

A Pharmacodynamics-Driven Trial of Talazoparib, an Oral PARP Inhibitor, in Patients With Advanced Solid Tumors and Aberrations in Genes Involved in DNA Damage Response

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Exploratory evaluations will be performed, with results reported with appropriate caveats about the exploratory nature of the analysis, and without formal adjustment for multiple comparisons.

Will be measured as the percent of patients who demonstrate simultaneous Rad51 activation, defined to be at least 5% cells with at least 5 Rad51 foci, and lack of gamma-H2AX activation, defined to be less than 4% nuclear area positive (NAP), at the cycle 2 day 1 biopsy.

Will estimate the overall response rate (complete response + partial response) among eligible patients who have received at least one dose of talazoparib. A 95% confidence interval for this response rate will also be computed. For this analysis, response classifications will follow Response Evaluation Criteria in Solid Tumors version 1.1 guidelines.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neoadjuvant Chemo-hormonal Therapy Combined With Radical Prostatectomy for Locally Advanced Prostate Cancer	NCT04220398	Prostate Cancer Chemotherapy Ef... Hormone Sensiti... Locally Advance...	Neoadjuvant che... Neoadjuvant hor... Radical Prostat...	18 Years - 75 Years	RenJi Hospital
Neoadjuvant Chemo-hormonal Therapy Combined With Radical Prostatectomy for Locally Advanced Prostate Cancer	NCT04220398	Prostate Cancer Chemotherapy Ef... Hormone Sensiti... Locally Advance...	Neoadjuvant che... Neoadjuvant hor... Radical Prostat...	18 Years - 75 Years	RenJi Hospital
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations	NCT04550494	Advanced Pancre... Anatomic Stage ... Anatomic Stage ... Castration-Resi... Clinical Stage ... Clinical Stage ... HER2-Positive B... Locally Advance... Locally Advance... Locally Advance... Locally Advance... Locally Advance... Locally Advance... Metastatic Brea... Metastatic Gast... Metastatic Mali... Metastatic Ovar... Metastatic Panc... Metastatic Pros... Platinum-Sensit... Stage II Pancre... Stage III Ovari... Stage III Pancr... Stage III Prost... Stage IV Ovaria... Stage IV Pancre... Stage IV Prosta...	Biopsy Biospecimen Col... Computed Tomogr... Magnetic Resona... Talazoparib	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for locally advanced prostate carcinoma