MCKAY UROLOGY RESEARCH: PROSTATE CANCER
PRINCIPAL INVESTIGATOR: Dr. Chris Teigland
Studies Open for Enrollment
Active Studies
Prostate Cancer Prevention Study:
Purpose of the trial: Reduce the incidence of developing prostate cancer in men with a diagnosis of High Grade PIN (prostatic intraepithelial neoplasia) on a prior biopsy. The trial is designed to evaluate the safety and effectiveness of toremifene citrate in this population.
Trial sponsor: GTx, Inc.
Randomization: The participant has a 50% chance of receiving the study drug.
Protocol: G300104
Phase: III
Enrollment status: Open
Contact for participation consideration: Jill Bradshaw, RN (704) 355-9342; jill.bradshaw@carolinashealthcare.org
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Provenge ® Study: (for men with hormone refractory Prostate Cancer that has spread beyond the prostate gland)
Purpose of the trial: This study is for patients who have cancer that has spread beyond the prostate gland. The purpose of the study is to determine if the investigational product, Provenge, is safe and effective for treatment of prostate cancer.
Provenge is designed to activate a man's antigen presenting cells (APCs) so they will launch a better immune response against prostate cancer. When they are activated, APCs can detect prostate cancer cells more readily and then alert the T-cells to the presence of the cancer. Once alerted, the T-cells can proceed to attack and destroy prostate cancer cells.
The protocol calls for immunotherapy with autologous antigen-presenting cells loaded with PA2024 (Provenge®, APC8015) in asymptomatic subjects with Gleason Sum greater than or equal to 7, metastatic, androgen-independent prostatic adenocarcinomas.
Trial sponsor: Dendreon Corp.
Randomization: Initially, the participant has a 67% chance of receiving the study drug. However, if the patient is initially placed in the placebo arm and reaches an end point, then he can crossover and receive the drug at that time.
Protocol: D9902B
Phase: III
Enrollment status: Open
Contact for participation consideration: Jill Bradshaw, RN; (704) 355-9342; Jill.Bradshaw@carolinashealthcare.org
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Atrasentan Study (for men with non-metastatic, hormone-refractory prostate cancer)
Purpose of the trial: This purpose of this study is to evaluate the safety and effectiveness of an investigational drug, Atrasentan, in the treatment of prostate cancer that has spread beyond the prostate gland. The trial is designed to evaluate the safety and efficacy of 10mg Atrasentan in men with non-metastatic, hormone-refractory prostate cancer.
Trial sponsor: Abbott Pharmaceuticals
Randomization: The participant has a 50% chance of receiving the study drug.
Protocol: M00-244
Phase: III
Enrollment status: Fully accrued; patients being followed on the study
Contact for participation consideration: N/A
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Atrasentan Trial (for men with hormone-naïve prostate cancer)
Purpose of the trial: The purpose of this study is to evaluate the safety and effectiveness of an investigational drug, Atrasentan, in men with advanced prostate cancer who have not been treated with hormones. These men are experiencing a rise in their Prostate Specific Antigen (PSA) blood level after receiving initial surgery or radiation therapy for their cancer. The study is designed to evaluate the safety and efficacy of Atrasentan (ABT-627) in men with hormone-naïve prostate cancer that are exhibiting early signs of biochemical failure. Atrasentan is a selective endothelin-A receptor antagonist that blocks the effects of endothelin-1.
Trial sponsor: Abbott Pharmaceuticals
Randomization: The participant has a 50% chance of receiving the study drug.
Protocol: M01-366
Phase: II
Enrollment status: Fully accrued; patients being followed on the study
Contact for participation consideration: N/A
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Amgen HALT Trial:
Purpose of the trial: Decrease bone loss in men undergoing hormone deprivation therapy for non-metastatic Prostate Cancer. This trial is designed to evaluate the safety and effectiveness of AMG 162 in this population.
Trial sponsor: Amgen
Randomization: The participant has a 50% chance of receiving the study drug.
Protocol: 20040138
Phase: III
Enrollment status: Fully accrued; patients being followed on the study.
Contact for participation consideration: N/A
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Guilford Study
Purpose of the trial: The purpose of this study is to evaluate the effects of GPI 1485 on erectile dysfunction in patients undergoing bilateral, nerve-sparing radical retropubic prostatectomy for prostate carcinoma.
This study is for patients newly diagnosed with prostate cancer who will have a radical prostatectomy (surgical procedure to remove the prostate gland). Most men have at least transient erectile dysfunction (the inability to have an erection sufficient for satisfactory sexual intercourse) after the prostatectomy.
GPI 1485 is an investigational drug being studied to see if it can protect the cavernous nerves from damage or if it can help re-grow damaged nerves after the surgery. McKay Urologyat Carolinas Medical Center is one of only ten sites nationwide selected to participate in this study.
Trial sponsor: Guilford Pharmaceuticals Inc.
Randomization: The patient has a 67% chance of receiving the drug.
Protocol: 0501-0202
Phase: II
Enrollment status: Fully accrued; patients being followed on the study
Contact for participation consideration: Jill Bradshaw, RN; (704) 355-9342; Jill.Bradshaw@carolinashealthcare.org
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Provenge® Study (for patients experiencing a rising PSA following their prostatectomy)
Purpose of the trial: The purpose of the study is to determine if the investigational product APC8015 is effective for treatment of prostate cancer following short-term (3 months) treatment with the hormone agent routinely used to treat this disease. It is for patients with non-metastatic prostate cancer who experience PSA elevation following radical prostatectomy. The study compares APC8015 to a control treatment to determine, after stopping the hormone treatment, whether the treatment with this vaccine delays the time until PSA reappears and rises to a level of 3.
Provenge is designed to activate a man's antigen presenting cells (APCs) so they will launch a better immune response against prostate cancer. When they are activated, APCs can detect prostate cancer cells more readily and then alert the T-cells to the presence of the cancer. Once alerted, the T-cells can proceed to attack and destroy the prostate cancer cells.
Trial sponsor: Dendreon Corp.
Randomization: The participant has a 67% chance of receiving the study drug.
Protocol: P11: Autologous, PAP-loaded dendritic cell vaccine (APC8015, Provenge™)
Phase: III
Enrollment status: Fully accrued; patients being followed on the study.
Contact for participation consideration: Jill Bradshaw, RN; (704) 355-9342; Jill.Bradshaw@carolinashealthcare.org
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REDUCE Study
Purpose of the trial: The purpose of the REDUCE study is to evaluate the safety and effectiveness of the medication Dutasteride as compared to placebo (an inactive substance) in reducing the risk of prostate cancer in high risk men. Prostate cancer is not always accompanied by symptoms, especially in its early stages; therefore, most cases are typically detected by screening tests.
The REDUCE study is designed to evaluate the efficacy and safety of Dutasteride 0.5mg, administered once daily for four years to reduce the risk of biopsy-detectable prostate cancer. Men who qualify for this study will be monitored closely over 4 years.
Trial sponsor: GlaxoSmithKline
Randomization: The patient has a 50% chance of receiving the study drug.
Protocol: ARI40006
Phase: IV
Enrollment status: Fully accrued; patients being followed on the study
Contact for participation consideration: Jill Bradshaw, RN; (704) 355-9342; Jill.Bradshaw@carolinashealthcare.org
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Phase-III Protocol of Androgen Suppression (AS) and Radiation Therapy (RT) versus AS and RT followed by Chemotherapy with Paclitaxel, Estramustine, and Etoposide for Localized High-Risk Prostate Cancer
Purpose of the trial: This protocol is for patients with prostate cancer that may be at risk for spreading outside the prostate. Its purpose is to evaluate the effectiveness and side effects of the combination of radiation therapy and hormones compared with radiation, hormones, and chemotherapy.
Trial sponsor: Radiation Therapy Oncology Group (RTOG)
Randomization:
Phase: III
Enrollment status: Closed
Contact for participation consideration: Blumenthal Cancer Center; (704) 355-2884 and 1-866-325-0103
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Phase-III Study Comparing Combined External Beam Radiation and Transperineal interstitial permanent brachytherapy with brachytherapy alone for selected patients with intermediate-risk prostatic carcinoma
Purpose of the trial: The purpose of this study is to evaluate the benefit in terms of overall survival of external beam radiation (EBRT) in addition to brachytherapy versus brachytherapy among men with intermediate risk prostate cancer.
Trial sponsor: Radiation Therapy Oncology Group (RTOG)
Randomization:
Protocol: RTOG 0232
Phase: III
Enrollment status: Closed
Contact for participation consideration: Blumenthal Cancer Center (704) 355-2884 and 1-866-325-0103
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