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

All Drugs and Chemicals

Testosterone

Androgens

Hormones

Hormone Antagonists

Testosterone 200 mg administered parenterally by intramuscular (IM) injection every 2 weeks

Initial dose of Testosterone 200 mg IM administered followed by 200 mg - 400 mg every 2 weeks.

Paul Mathew, MD

Primary Objective:

1. To assess the prostate-specific antigen (PSA)-response (50% decline) to Testosterone Replacement Therapy (TRT) in men with "intermediate and good-risk" Castration-Resistant Prostate Cancer (CRPC).

Secondary Objectives:

1. To assess the objective response and time-to-progression with TRT in CRPC.
2. To assess serial changes in quality of life with TRT in these CRPC subsets.
3. Translational: To study kinetics of circulating tumor cells with TRT and molecular correlates of response to TRT in CRPC.

Generally, castration therapy has been used indefinitely for prostate cancer patients because some tumors seem to grow faster with testosterone present. Researchers want to study the effect of testosterone only in patients whose tumors have had a maximum response to castration therapy. Researchers want to find out if these patients' disease may be better controlled with testosterone replacement therapy.

Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Your complete medical history will be recorded and there will be a review of all medicines you may be currently taking. You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate). You will have blood drawn (about 4 teaspoons) and urine collected for routine tests. You will have a chest x-ray, an electrocardiogram (ECG--a test to measure the electrical activity of the heart), a bone scan, and a computed tomography (CT) scan of your abdomen and pelvis. If the study doctor thinks it is necessary, you may have an assessment of your mental status. For this assessment, you will be asked questions about your attention span, memory, and mood disturbances. It will take about 25 minutes to complete.

If you are found to be eligible to take part in this study, you will begin receiving testosterone enanthate replacement therapy every 2 weeks by an injection into a muscle.

Every 2 weeks, you will go to the clinic for your testosterone injection, and blood (about 2 teaspoons) will be drawn to check the testosterone level in your blood. This will help the study doctor learn what dose you will receive for the next 2 weeks. After your Week 8 visit, blood (about 2 teaspoons) will be drawn to check the testosterone level in your blood every 4 weeks for the rest of your time on this study.

At the Week 8 and 24 visits, you will have a physical exam, including measurement of your vital signs. You will be asked about any side effects you may be experiencing. Your disease status will be evaluated to learn its response to treatment. Blood (about 4 teaspoons) will be drawn for routine tests, and you will have repeat imaging scans (like the ones you had at your screening visit) to evaluate your disease. If the study doctor thinks that your mental status should be assessed again, you will have another assessment (at or around Week 24) like the one completed during your screening visit.

You may remain on this study indefinitely unless your disease gets worse or you experience any intolerable side effects.

If your participation ends on this study for any of the above reasons, you will have an end-of-study visit. During this visit, you will have blood drawn (about 4 teaspoons) for routine testing. You will be asked about any side effects you may be experiencing, and your disease response to treatment will be evaluated.

This is an investigational study. Testosterone enanthate is commercially available. Testosterone replacement therapy is not FDA approved for this disease, and in some cases, has been disallowed for use in prostate cancer. Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.

Testosterone in Castration-Resistant Prostate Cancer

Testosterone Replacement Therapy in Castration-Resistant Prostate Cancer

Rate is the number of participants with PSA-response defined as PSA \> or equal to 50%-decline in PSA from baseline value sustained for at least 4 weeks with be no evidence of progressive disease.

M.D. Anderson Cancer Center

Digestive System Diseases

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Uterine Cervical Neoplasms

Esophageal Neoplasms

Breast Neoplasms

Triple Negative Breast Neoplasms

Carcinoma, Non-Small-Cell Lung

Stomach Neoplasms

Lung Neoplasms

Breast Diseases

Skin Diseases

Esophageal Cancer

Stomach Cancer

According to the cell transfusion protocol, GK01 cells were given at a certain dose level to observe the safety and tolerability of the patients after the transfusion, explore the pharmacokinetic/pharmacodynamic characteristics after the transfusion, and preliminarily evaluate the effectiveness of the experimental drug GK01 cells according to the RECIST 1.1 standard.

The strengthened T cells are re-infused into the patient to achieve the killing effect

TCR T-cells

Yi Zhang, Doctor

Ge Zhang

This trial plans to enroll many patients with advanced solid tumors to complete GK01 cell transfusion, including but not limited to advanced gastric cancer, esophageal cancer, cervical cancer, triple-negative breast cancer, and non-small cell lung cancer. For patients with advanced solid tumors eligible for inclusion, autologous tumor-reactive T cells (experimental drug GK01) were cultured and prepared, and a certain dose of GK01 cells was given according to the cell transfusion plan, and the safety and tolerability of the patients after transfusion were observed. Exploratory evaluation of pharmacokinetic/pharmacodynamic profiles following reinfusion and initial evaluation of efficacy of investigational drug GK01 cells according to RECIST 1.1 criteria.

a Single-arm, Single-center, Open Clinical Study

Clinical Study on the Safety and Efficacy of GK01 Autologous Tumor-reactive T Cells (TRT) in Patients With Advanced Solid Tumors

To evaluate the safety and tolerability of GK01 autologous tumor-reactive T cells (TRT) in patients with advanced solid tumors.

To explore the specificity and persistence of GK01 autologous tumor-reactive T cells (TRT) expansion in patients with advanced solid tumors

To evaluate the initial efficacy of GK01 autologous tumor-reactive T cells (TRT) in the treatment of patients with advanced solid tumors based on RECIST 1.1 criteria

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Testosterone in Castration-Resistant Prostate Cancer	NCT00577980	Prostate Cancer	Testosterone	-	M.D. Anderson Cancer Center
a Single-arm, Single-center, Open Clinical Study	NCT06431100	Gastric Cancer Esophageal Canc... Cervical Cancer Non-Small Cell ... Triple Negative...	TCR T-cells	18 Years - 75 Years	Beijing Geekgene Technology Co., LTD
Testosterone in Castration-Resistant Prostate Cancer	NCT00577980	Prostate Cancer	Testosterone	-	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for trt

Every month we try and update this database with for trt 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 trt

Every month we try and update this database with for trt 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 trt 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.