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Prostatic Neoplasms clinical trials

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NCT ID: NCT00040755 Completed - Bone Metastases Clinical Trials

BMS-275291 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy

Start date: May 2002
Phase: Phase 2
Study type: Interventional

BMS-275291 may stop the growth of prostate cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for tumor cell growth. Randomized phase II trial to study the effectiveness of BMS-275291 in treating patients who have prostate cancer that has not responded to hormone therapy

NCT ID: NCT00040586 Completed - Prostatic Neoplasms Clinical Trials

Phase II Trial of Monoclonal Antibody (J591) in Combination With Low-Dose Subcutaneous Interleukin-2

Start date: n/a
Phase: Phase 2
Study type: Interventional

The monoclonal antibody J591 is being investigated as therapy for patients with prostate cancer, in combination with recombinant interleukin-2 (Proleukin, Aldesleukin). The study is an open-label, non-randomized phase II study for patients with documented hormone refractory prostate cancer.

NCT ID: NCT00040365 Completed - Prostatic Neoplasms Clinical Trials

Amifostine to Protect the Rectum During External Beam Radiotherapy for Prostate Cancer

Start date: June 2002
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety and effectiveness of a drug called amifostine in reducing the bowel side effects of radiation treatment for prostate cancer. Amifostine is a 'radioprotector' medicine that to protects normal tissue from radiation damage. This study will determine whether placing amifostine in the rectum during radiation treatment for prostate cancer can decrease common side effects of treatment, including diarrhea, painful bowel movements, bleeding, and gas. Patients 18 years of age or older with prostate cancer may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood tests, bone scan if a recent one is not available, and possibly computed tomography (CT) and magnetic resonance imaging (MRI) scans of the pelvis. They will also have a liquid retention test, in which they are given an enema of 4 tablespoons of salt water that they must retain for 20 minutes. Participants will receive standard radiation therapy for prostate cancer-5 consecutive days for 8 weeks-in the National Institutes of Health (NIH) Radiation Oncology Clinic. Amifostine will be placed in the rectum by a mini-enema before each radiation treatment so that it covers the lining of the rectum. To determine the side effects of the treatment, patients will undergo a proctoscopic examination before beginning radiation therapy, two times during therapy, and at each follow-up visit for 5 years after treatment ends. This examination involves inserting a proctoscope (a thin flexible tube with a light at the end) into the rectum and taking pictures. Patients will be followed in the clinic at visits scheduled 1, 3, 6, 12, 18, 24, 36, 48, and 60 months after treatment for a physical examination and routine blood tests, proctoscopic examination, and review of bowel symptoms.

NCT ID: NCT00039793 Completed - Breast Neoplasms Clinical Trials

Massage Therapy for Cancer-Related Fatigue

Start date: March 2001
Phase: Phase 2
Study type: Interventional

The purpose of this study is to develop methods for studying the effect of bodywork therapy on symptoms of fatigue in patients undergoing cancer chemotherapy.

NCT ID: NCT00039624 Completed - Prostate Cancer Clinical Trials

Magnetic Resonance-Guided High-Dose Brachytherapy (Short-Range Radiation Therapy) for Prostate Cancer

Start date: June 3, 2002
Phase: Phase 2
Study type: Interventional

This study will evaluate the use of magnetic resonance imaging (MRI) for guiding placement of hollow needles into the prostate gland for delivering internal radiation therapy to patients with prostate cancer. Prostate cancer is often treated with a combination of external beam radiation therapy and brachytherapy (internal radiation delivered close to the tumor). This study will determine whether MRI is more accurate in guiding needle placement than ultrasound, which is currently used for this purpose. Patients will have one brachytherapy treatment followed by 5 weeks of external beam treatments and a second brachytherapy. Patients 18 years of age and older with prostate cancer that has not spread to the bone may be eligible for this study. Candidates will be screened with a physical examination, blood and urine tests, and a bone scan. To plan for radiation therapy, patients will have standard computed tomography (CT) and MRI scans of the pelvis and prostate. In addition, CT and MRI scans will be done to determine if the prostate is in a good position for brachytherapy. For these scans, patients will have an enema and a tube will be placed in the rectum. They will then lie still on their side for about 45 minutes during the scan. Patients who have blood in their urine will also undergo cystoscopy. This is an examination of the bladder using a small camera that is advanced through the penis into the bladder. Patients are given an antibiotic for 2 days before the brachytherapy and on the morning of the procedure. Before the test, they have a small enema and are given medicines through the vein and into the spine for relaxation and to decrease any discomfort. (The test is done under general anesthesia for patients who require it.) The patient is moved on a stretcher into the MRI scanner and a catheter is inserted into the bladder through the penis. The bladder is filled with water and a tube is placed in the rectum. With the help of a plastic guide placed against the skin, about 14 to 18 needles are then placed in the prostate. Some stitches are sewn to hold the needles and the guide in place, and the tube in the rectum is removed. The patient is the transferred from the MR scanner into the CT scanner, where the rectal tube is reinserted and the needles are adjusted. A cystoscopy is done to make sure the needles do not enter the bladder. When the needles are adjusted, the tube is removed from the rectum and the patient is moved to the radiation oncology clinic. After a few hours, when the radiation dose has been calculated, a radioactive substance called iridium is administered. The needles placed in the prostate are connected to a radiation machine, and thin wires with radioactive material on the tips are inserted into each needle and withdrawn a little at a time. The process takes about 20 to 30 minutes. The patient is then disconnected from the machine and undergoes another MRI scan to confirm the position of the needles. The needles and catheter are then removed and the patient is monitored for a while before going home. Patients then have 5 weeks of external beam therapy, followed by a second brachytherapy treatment. Patients return to the clinic at 1, 3, 6, 12, 18, 24, 36, 48, and 60 months after treatment for blood tests, physical examination, and review of symptoms.

NCT ID: NCT00039299 Completed - Prostate Cancer Clinical Trials

Biological Therapy in Treating Patients With Prostate Cancer

Start date: March 2002
Phase: Phase 1
Study type: Interventional

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop tumor cells from growing. Treating a person's T cells in the laboratory and then reinfusing them may cause a stronger immune response and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of T-cell therapy in treating patients who have prostate cancer that has not responded to hormone therapy.

NCT ID: NCT00039104 Completed - Clinical trials for Adenocarcinoma of the Prostate

Zoledronate and BMS-275291 in Treating Patients With Prostate Cancer

Start date: April 2002
Phase: Phase 2
Study type: Interventional

Phase II trial to study the effectiveness of combining zoledronate with BMS-275291 in treating patients who have prostate cancer that has not responded to previous hormone therapy. Zoledronate may prevent bone loss and stop the growth of tumor cells in bone. BMS-275291 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. Combining zoledronate with BMS-275291 may kill more tumor cells.

NCT ID: NCT00038662 Completed - Prostatic Neoplasms Clinical Trials

Safety and Efficacy of Atrasentan in Men With Hormone Naive Prostate Cancer Exhibiting Early Signs of Biochemical Failure

Start date: May 2002
Phase: Phase 2
Study type: Interventional

The purpose of this phase II, randomized, double-blind placebo controlled, multi-center study is to evaluate the safety and efficacy of 10 mg atrasentan in hormone naive subjects as measured by rate of rise in the PSA (primary objective).

NCT ID: NCT00038246 Completed - Prostate Cancer Clinical Trials

Study of Paclitaxel, Estramustine Phosphate and Thalidomide for Patients With Metastatic Androgen-Independent Prostate Carcinoma

Start date: October 2000
Phase: Phase 1/Phase 2
Study type: Interventional

The three study drugs (Thalidomide, Taxol, and Estramustine) used in this study are all chemotherapy drugs used in shrinking the cancer.

NCT ID: NCT00038194 Completed - Prostate Cancer Clinical Trials

Phase I Trial of Fixed Dose STI571 (Imatinib Mesylate) With Escalating Doses of Docetaxel in Patients With Metastatic Androgen-Independent Prostate Cancer

Start date: October 2001
Phase: Phase 1
Study type: Interventional

The goal of this clinical research study is to find the highest safe dose of docetaxel in combination with Gleevec (imatinib mesylate) that can be given to men with advanced androgen-independent metastatic prostate cancer that involves bone. Docetaxel is a commercial chemotherapy which interferes with the cancer cell ability to divide and grow.