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

Abiraterone Acetate

Tacrolimus

Rong Han

This is an observational, prospective (study following participants forward in time), multi-center (study conducted in more than 1 center) study to identify the predictive factors that will effectively predict the response to abiraterone treatment in metastatic castration-resistant prostate cancer (mCRPC). The entire duration of study will be approximately 3 year. Participants will primarily be evaluated for achieving biochemical or radiological progression after receiving abiraterone treatment based on EAU 2017 practice guideline criteria. For this, we put our attentions on the HOXB3 (an alternative factor of WNT signaling pathway), FKBP5 (FK506 Binding Protein 5, Androgen-regulated gene), NTS (neurotensin, neuroendocrine differentiation can be induced by NTS) and YAP1 (yes-associated protein 1, a biomarker for cancer stem cell), which are selected from the data of gene-array for various subtypes of CRPC (unpublished data). Response to abiraterone treatment will also be predicted using other androgen-regulated genes like AKR1C3 and PCNA.

It is now accepted that castration-resistant prostate cancer (CRPC) is not really androgen-independent and continues to rely on androgen signaling. Abiraterone is an inhibitor of cytochrome P450 17A1 (CYP17A1) that impairs androgen-receptor signaling by depleting adrenal and intratumoral androgens. After studies showed improved survival with abiraterone, it was approved by the Food and Drug Administration for the treatment of metastatic castration-resistant prostate cancer (mCRPC).

mCRPC is a syndrome other than a disease. The mechanisms of mCRPC contain aberrant activation of androgen signaling, abnormal transition between epithelial and mesenchymal and induction of neuroendocrine differentiation (NED). In addition, cellular heterogeneity represents an omnipresent feature in human tumors, which contain cells with diverse morphology, cytogenetic markers, growth kinetics, immunological characteristics, metastatic ability, and sensitivity to therapeutics.

This is an observational, prospective (study following participants forward in time), multi-center (study conducted in more than 1 center) study to identify the predictive factors that will effectively predict the response to abiraterone treatment in metastatic castration-resistant prostate cancer (mCRPC). The entire duration of study will be approximately 3 year. Participants will primarily be evaluated for achieving biochemical or radiological progression after receiving abiraterone treatment based on EAU 2017 practice guideline criteria. For this, we put our attentions on the FKBP5 (FK506 Binding Protein 5, Androgen-regulated gene), NTS (neurotensin, neuroendocrine differentiation can be induced by NTS) and YAP1 (yes-associated protein 1, a biomarker for cancer stem cell), which are selected from the data of gene-array for various subtypes of CRPC. Response to abiraterone treatment will also be predicted using other androgen-regulated genes like AKR1C3 and PCNA.

RNA-seq with IHC of AKR1C3, FKB5 and PCNA were tested in the tissue specimen.

Tissue Predictors of Abiraterone Benefit

Development of Tissue Predictors of Abiraterone Benefit in Men With mCRPC

PSA response rates between FKBP5(protein)-positive and FKBP5(protein)-negative (including YAP1-positive and NTS-positive) patients; PSA response rates between patients with higher or lower expression of androgen-regulated genes (AKR1C3, FKB5, PCNA).

pPFS between FKBP5-positive and FKBP5-negative (including YAP1-positive and NTS-positive) patients; pPFS between patients with higher or lower expression of androgen-regulated genes (AKR1C3, FKB5, PCNA).

cPFS between FKBP5-positive and FKBP5-negative (including YAP1-positive and NTS-positive) patients; cPFS between patients with higher or lower expression of androgen-regulated genes (AKR1C3, FKB5, PCNA).

OS between FKBP5-positive and FKBP5-negative (including YAP1-positive and NTS-positive) patients; OS between patients with higher or lower expression of androgen-regulated genes (AKR1C3, FKB5, PCNA).

Tianjin Medical University General Hospital

Tianjin Medical University Cancer Institute and Hospital

Beijing Chao Yang Hospital

The Second Hospital of Hebei Medical University

Affiliated Hospital of Hebei University

Tianjin Medical University Second Hospital

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Antirheumatic Agents

Micronutrients

Natriuretic Agents

Anti-Infective Agents

Hematinics

Other Dietary Supplements

Vitamins

Paclitaxel

Albumin-Bound Paclitaxel

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Thioctic Acid

Antioxidants

Natriuretic Peptide, Brain

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Tubulin Modulators

Antimitotic Agents

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Alpha-lipoic Acid

Folate

Vitamin B9

• Group one: 32 patients will receive four cycles of AC followed by weekly taxol for 12 weeks plus Placebo.

• Group two: 32 patients will receive four cycles of AC followed by weekly taxol for 12 weeks in addition to oral 600 mg alpha lipoic acid (ALA) once daily.

600 mg Alpha-lipoic acid daily (an antioxidant that's in many foods, and it's made naturally in the investigator's bodies) with four cycles of doxorubicin (also known as Adriamycin) plus cyclophosphamide followed by weekly taxol for 12 weeks..

Alpha-lipoic acid Plus Chemotherapy (doxorubicin (also known as Adriamycin) plus cyclophosphamide followed by taxol)

Placebo with four cycles of doxorubicin (also known as Adriamycin) plus cyclophosphamide followed by weekly taxol for 12 weeks.

Placebo Plus Chemotherapy (doxorubicin (also known as Adriamycin) plus cyclophosphamide followed by taxol)

Reham A Elshafiey, PharmD

• Investigate the ability of alpha lipoic acid to counter act anthracycline associated cardiotoxicity and cumulative taxens-related PN in patients with breast cancer.

Fifty breast cancer patients with stage from stage I to stage III will be involved in this study. Staging is done according to the American joint committee on cancer: TNM staging of breast cancer.

* All participants will be recruited from Tanta Oncology Center. The study will be approved by Research Ethics Committee of Damanhour University. All participants will give their consent.
* All 64 patients will be scheduled to receive 4 cycles of AC: cycled every 21 days followed by weekly cycle of taxol for 12 weeks.

Patients will be classified as follow:

* Group one: 32 patients will receive four cycles of AC followed by weekly taxol for 12 weeks plus placebo.
* Group two: 32 patients will receive the same regimen as group 1 in addition to oral 600 mg alpha lipoic acid (ALA) once daily.

All patients will be submitted to:

1. Full patient history and clinical examination.
2. Venous blood will be collected before the first cycle of chemotherapy and after the last cycle of chemotherapy.

1- Cardio-toxcity assessment: i. Echo-cardiogram. ii. Troponin I. iii. The Brain Natriuretic Peptide (BNP). 2- Neurotoxicity assessment: i. National Cancer Institute common Terminology criteria for Adverse Effect grading: NCI-CTCAE version 4.0.

ii. Neurotoxicity questionnaire from the validated Functional Assessment of cancer therapy/gynecologic oncology group taxane specific neurotoxicity questionnaire: FACT-Taxane.

iii. Neurotensin 3- Oxidative stress and inflammatory markers: i. Malondialdehyde (MDA). ii. TNF-alpha

Double-blind study, Patients will be classified as follow:

* Group one: 32 patients will receive four cycles of AC followed by weekly taxol for 12 weeks plus placebo.
* Group two: 32 patients will receive four cycles of AC followed by weekly taxol for 12 weeks plus oral 600 mg alpha lipoic acid (ALA) once daily.

Alpha-Lipoic Acid in Breast Cancer Patients

Role of Alpha-Lipoic Acid Against Chemotherapy Induced Toxicities in Breast Cancer Patients

serum Brain Natriuretic Peptide (BNP) level

Damanhour University

Lecturer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tissue Predictors of Abiraterone Benefit	NCT03176381	Metastatic Cast...		18 Years -	Tianjin Medical University Second Hospital
Tissue Predictors of Abiraterone Benefit	NCT03176381	Metastatic Cast...		18 Years -	Tianjin Medical University Second Hospital
Alpha-Lipoic Acid in Breast Cancer Patients	NCT03908528	Breast Cancer Chemotherapeuti...	Alpha-lipoic ac... Placebo Plus Ch...	18 Years - 70 Years	Damanhour University
Tissue Predictors of Abiraterone Benefit	NCT03176381	Metastatic Cast...		18 Years -	Tianjin Medical University Second Hospital
Alpha-Lipoic Acid in Breast Cancer Patients	NCT03908528	Breast Cancer Chemotherapeuti...	Alpha-lipoic ac... Placebo Plus Ch...	18 Years - 70 Years	Damanhour University

Spots Global Cancer Trial Database for neurotensin

Every month we try and update this database with for neurotensin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for neurotensin

Every month we try and update this database with for neurotensin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for neurotensin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.