Prostate

ID:AAAD2231

Industry
Principal Investigator: Dr. Edward Gelmann

Adult: Extended 39-Week Study of PSMA ADC Following the Initial 12-week Dose-Escalation Study in Subjects with Progressive, Castration-Resistant, Metastatic Prostate Cancer

PSMA ADC 1301EXT is an open label, non-randomized, Phase 1 extension study of IV PSMA ADC in subjects with progressive, castration-resistant, metastatic prostate cancer who have had previous taxane therapy and who participated in the main study PSMA ADC 1301.The purpose of this research study is twofold: 1) to allow the subject to continue to receive PSMA ADC at the dose they are currently receiving for up to 39 weeks and 2) to determine the long-term safety of PSMA ADC. PSMA ADC belongs to a class of medicines called Antibody-Drug Conjugates. PSMA ADC is made up of three parts: an antibody, a drug with the potential to kill cancer cells, and a linker that holds the first two parts together. The antibody in PSMA ADC ?recognizes? a protein on the surface of prostate cancer cells called Prostate-Specific Membrane Antigen (PSMA) and binds to it. Once bound, it releases the cancer-killing drug portion into the prostate cancer cells. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Prostate

ID:AAAE4046

Cooperative Group
Principal Investigator: Dr. Edward Gelmann

Adult: CHAARTED: ChemoHormonal Therapy versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer

The purpose of this study is to evaluate a new way of treating patients with prostate cancer. In Arm A, patients will receive docetaxel chemotherapy both at the time they start hormonal therapy and later when/if the hormonal therapy is no longer working. In Arm B, patients only get chemotherapy when/if the hormonal therapy is no longer working. The study is being done to see if there is a benefit to giving chemotherapy at the beginning. Hormonal therapy refers to drugs or surgical procedures such as an orchiectomy (removal of testicles) which lowers testosterone. This puts prostate cancer into remission in most patients as the testosterone is like a fuel for the cancer. It is the standard to give this as the only treatment for prostate cancer. Normally chemotherapy is reserved for when a patient?s cancer starts to grow again despite having a low testosterone level. In this study patients will either get docetaxel when they start their hormonal therapy or when/if the cancer grows with a low testosterone level. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Prostate

ID:AAAI7304

Cooperative Group
Principal Investigator: Dr. Edward Gelmann

Adult: S1014: Abiraterone Acetate Treatment for Prostate Cancer Patients with a PSA of More Than Four Following Initial Androgen Deprivation Therapy, Phase II

This is a phase 2 research study of abiraterone acetate for subjects who have cancer of the prostate that is only partially responding to hormone therapy. The main goal of this study is to see if abiraterone acetate with prednisone reduces PSA.The purpose of this study is to find out what effects, good and/or bad, abiraterone acetate has on you and your prostate cancer. The effect of the prostate cancer will be measured by a blood test (prostatic specific antigen or PSA). Abiraterone acetate is a hormonal tablet that has been approved by the Food and Drug Administration (FDA) for more advanced prostate cancer patients who have received chemotherapy. It is considered investigational for your type of prostate cancer. We will be looking to see if abiraterone acetate improves the effectiveness of standard hormonal shots or injections. The prostate specific antigen (PSA) is a blood test used in prostate cancer screening and also to follow prostate cancer. In this study, we will follow your PSA level to help determine if abiraterone acetate is beneficial. You can participate in this study if you meet the following criteria at minimum:- Proven diagnosis of metastatic prostate cancer - You must be receiving androgen deprivation therapy (ADT) prior to entering this study- You must have sub-optimal response to ADT (i.e. PSA below the PSA level prior to starting ADT)- You must not have a history of Class III and IV heart failure or a known left ventricular ejection fraction (LVEF) of < 50%. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Prostate

ID:AAAI1664

Industry
Principal Investigator: Dr. Edward Gelmann

Adult: A Phase 1b Safety Study of Abiraterone Acetate (JNJ 212082) and Docetaxel in Subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC)

This is a Phase 1b Safety Study of Abiraterone Acetate (JNJ 212082) and Docetaxel in Subjects who have been diagnosed with Metastatic Castration-Resistant Prostate Cancer (mCRPC) The purpose of this study is to determine a safe dose combination of abiraterone acetate (JNJ-212082) and docetaxel in subjects with mCRPC. Abiraterone acetate is an experimental drug that is being tested to see if it may be useful in treating metastatic castration-resistant prostate cancer (mCRPC). This study will look at the effects of abiraterone acetate in combination with docetaxel (sold as Taxotere) and prednisone. Dexamethasone will also be given in this study to help manage side effects to docetaxel. Abiraterone acetate is not yet approved by the U.S. Food and Drug Administration (FDA) as a treatment for any disease and is not commercially available in the United States. Therefore, it can only be used in a research setting such as this one. Abiraterone acetate is a drug that blocks any remaining male hormones in the body that may be helping your prostate cancer to grow. Docetaxel infusion is a well established anti-cancer chemotherapy drug (a drug that uses chemical agents or drugs to kill cancer cells). Docetaxel infusion in combination with prednisone is approved for use by the U. S. Food and Drug Administration (FDA) for the treatment of metastatic prostate cancer.Prednisone and dexamethasone are man-made hormones commonly referred to as a steroid. Dexamethasone is used to prevent or reduce fluid retention in patients taking docetaxel. Prednisone and a similar drug, prednisolone, reduce inflammation and treat symptoms of various disorders and diseases. Although prednisone/prednisolone is commonly prescribed to subjects with mCRPC, it has not been approved to treat this disease by the FDA. Subjects who have not undergone orchiectomy (surgical removal of the testicles), must be on treatment with a luteinizing hormone-releasing hormone (LHRH) agonist to be eligible for this study. They must stay on LHRH agonist treatment through-out the entire study. An LHRH agonist is a man-made hormone which slows testosterone production. Testosterone helps prostate cancer to grow. All subjects participating in this study will receive abiraterone acetate. All subjects will also receive docetaxel via a 1 hour IV (through the vein) infusion every 3 weeks. Dexamethasone will be given before the start of each docetaxel infusion. All subjects will also take prednisone and an LHRH agonist (if needed) through-out the study. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Prostate

ID:AAAF3321

Institutional
Principal Investigator: Dr. Ketan Badani

Adult: VTI Doppler Probe For Robotic Surgery

Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Kidney, Other Urinary, Prostate, Bladder

ID:AAAE9906

Cooperative Group
Principal Investigator: Dr. Edward Gelmann

Adult: A RANDOMIZED DOUBLE-BLINDED PHASE III STUDY COMPARING GEMCITABINE, CISPLATIN, AND BEVACIZUMAB (IND #7921, NSC #704865) TO GEMCITABINE, CISLPATIN, AND PLACEBO IN PATIENTS WITH ADVANCED TRANSITIONAL CELL CARCINOMA

This is a randomized, multi-center double-blinded phase III research study.The purpose of this study is to compare the effects of the combination of the chemotherapy drugs gemcitabine and cisplatin (chemotherapy) with the combination of gemcitabine, cisplatin, and the experimental drug bevacizumab on subjects with transitional cell cancer of the urinary tract to find out which is better. Bevacizumab is an antibody that may block a protein called VEGF and inhibit the growth of new blood vessels. Bevacizumab has been approved by the FDA for the treatment of metastatic colorectal, lung, and breast cancer, but for transitional cell carcinoma, it is not FDA-approved and should be considered experimental.Bevacizumab is the common name for the commercial drug Avastin. The bevacizumab used in this trial, however, is for use in research studies only. The combination of gemcitabine and cisplatin is one commonly used treatment that has been shown to make some patients with transitional cell carcinoma live longer. This research is being done to see if adding bevacizumab to gemcitabine and cisplatin will delay the growth of this cancer and allow subjects to live longer. The National Cancer Institute (NCI) will provide Bevacizumab free of charge to subjects who are participating in this study. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Prostate

ID:AAAI1692

Industry
Principal Investigator: Dr. Edward Gelmann

Adult: A Multicenter, Open-label, Single-arm, Phase 2 Study of Abiraterone Acetate Plus Prednisone in Subjects with Advanced Prostate Cancer Without Radiographic Evidence of Metastatic Disease

This study will look at the effects of abiraterone acetate in combination with prednisone in patients with prostate cancer. Study medication in this study includes abiraterone acetate and prednisone.The purpose of this study is to show that abiraterone acetate plus prednisone added to the current standard of care, gonadotropin-releasing hormone (GnRH) decreases prostate specific antigen (PSA) and prolongs the time until it is evident that the cancer has grown. Additionally, safety information about abiraterone acetate in combination with prednisone will be collected. This will include looking at what side effects occur, how often they occur, and for how long they last.You will receive abiraterone acetate and prednisone.Abiraterone acetate is a drug that blocks the remaining or residual male hormones in the body that may be helping your prostate cancer to grow. Abiraterone acetate is an experimental drug that is being tested to see if it may be useful in treating non-metastatic castration-resistant prostate cancer (CRPC). On April 28, 2011, the United States Food and Drug Administration (FDA) approved Abiraterone Acetate in combination with prednisone to treat patients with late-stage (metastatic) castration-resistant prostate cancer who have received prior docetaxel (chemotherapy).Prednisone is usually used to reduce inflammation and to treat symptoms of various disorders and diseases. Although prednisone is commonly prescribed to patients with CRPC, it has not been approved for this treatment by the FDA. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Prostate

ID:AAAF2761

Cooperative Group
Principal Investigator: Dr. Israel Deutsch

Adult: A Phase III Trial Of Short Term Androgen Deprivation With Pelvic Lymph Node Or Prostate Bed Only Radiotherapy (SPPORT) In Prostate Cancer Patients With A Rising PSA After Radical Prostatectomy (RTOG 0534)

This is a Phase III research study for subjects who have had surgery to remove their prostate and due to a rising Prostate Specific Antigen (PSA) will undergo radiation therapy. The purpose of this study is to compare the effects, good and/or bad of three treatment methods on participants cancer. External beam radiation therapy is one of the standard treatments for men with prostate cancer who have a rising PSA after surgery. Different methods of radiation therapy are used, and it is not known which one is best. Most commonly, the area where the prostate was originally located before being removed (the prostate bed) is treated, without treating the lymph nodes in the pelvis. Prostate cancer can spread to the lymph nodes. There is some evidence in men who have not had surgery that radiotherapy to the pelvic lymph nodes may stop the cancer from spreading under some conditions. Since treating the pelvic lymph nodes can result in increased side effects, the benefit of this method of radiation therapy needs to be tested.Prostate cancer feeds on male hormones, such as testosterone. Drugs that reduce or block testosterone (hormone therapy) can cause some prostate cancer cells to die and others to become sick so that they don?t grow. Some patients treated with a combination of these drugs and radiation have a greater chance of not having the cancer return when compared to men treated with radiation alone. These studies were done in men who did not have surgery. Since hormone therapy can result in increased side effects, the benefit of combining hormone therapy with radiation therapy needs to be tested.There are 3 treatment groups in this study:1) Patients who receive radiation therapy to the prostate bed only;2) Patients who receive hormone therapy for 4 to 6 months plus radiation therapy to the prostate bed; 3) Patients who receive hormone therapy for 4 to 6 months plus radiation therapy to the prostate bed and to the pelvic lymph nodes. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Prostate

ID:AAAK5550

Industry
Principal Investigator: Dr. Edward Gelmann

Adult: A Study of HSP90 Inhibitor AT13387 Alone or in Combination with Abiraterone Acetate in the Treatment of Castration-Resistant Prostate Cancer (CRPC) no Longer Responding to Abiraterone

This is a research study HSP90 Inhibitor AT13387 alone or in combination with Abiraterone Acetate with Castration-Resistant Prostate Cancer (CRPC) who are no longer responding to AbirateroneAT13387 is a small molecule that binds to a cell protein called Heat Shock Protein 90 (HSP90). HSP90 is required for proper cell growth. When AT13387 binds to HSP90, the growth of the cell can be slowed down. Early lab studies have shown that AT13387 can prevent growth in a range of tumor cell types, including prostate cancer. The study drug that will be used in this study, (AT13387), is investigational. This means it has not been approved for use by the United States Food and Drug Administration (FDA) except in studies such as this one. The other drug used in this study, abiraterone acetate, is approved for use by the FDA in combination with steroids (prednisone or prednisolone) for the treatment of prostate cancer. The purpose of this research study is to look at the safety and tolerability of AT13387 when given alone or in combination with abiraterone acetate and steroids (prednisone or prednisolone), and to determine the best treatment plan (dose and frequency of treatments) for AT13387 alone and in combination with abiraterone acetate and steroids when given to patients with prostate cancer who are no longer responding to treatment with abiraterone acetate and steroids alone. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Prostate

ID:AAAK6555

Institutional
Principal Investigator: Dr. Saravanan Krishnamoorthy

: Utility of Endorectal Coil MRI to Improve Accuracy of Detecting and Evaluating Localized Prostate Cancer

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Prostate

ID:AAAK7758

Industry
Principal Investigator: Dr. Ketan Badani

Adult: Prospective, Non-Randomized Feasibility Clinical Study Using the NIM-ECLIPSEreg; for Intraoperative Nerve Monitoring during Robotic Radical Prostatectomy

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.