Clinical Trial NU MSK13U01
- A phase 2, randomized, 3-arm study of abiraterone acetate alone, abiraterone acetate plus degarelix, a GnRH antagonist, and degarelix alone for patients with prostate cancer with a rising PSA or a rising PSA and nodal disease following definitive radical prostatectomy
- Principal Investigator
- Timothy Kuzel
- Status: Accepting New Patients
- Study Type: Therapeutic, Treatment
- Protocol No:.NU MSK13U01
- The purpose of this study is to evaluate abiraterone acetate and prednisone in combination with degarelix as a possible treatment for Prostate-Specific Antigen (PSA) recurrent prostate cancer as compared to abiraterone acetate alone and degarelix alone.
- In April 2011 the United States Food and Drug Administration (FDA) approved the oral drug abiraterone acetate (Zytiga ®) in combination with prednisone (a steroid) to treat patients with metastatic (spreading) castration-resistant prostate cancer (prostate cancer that is resistant to medical or surgical treatments that lower testosterone) who have received prior docetaxel (chemotherapy). In December 2012, the FDA approved Zytiga ® in combination with prednisone to treat patients with metastatic (spreading) castration-resistant prostate cancer (prostate cancer that is resistant to medical or surgical treatments that lower testosterone) who have not received prior chemotherapy.Degarelix (Firmagon ®), a testosterone lowering agent given as a monthly injection is FDA approved for the treatment of patients with advanced prostate cancer. This will be the first time these drugs will be used together.
Some of the eligibility criteria include:
- Participants must be males 18 years old or older.
- Participants must have advanced prostate cancer.
- Participants must have undergone a radical prostatectomy (surgical removal of the prostate gland) and had a normal PSA after surgery that is now rising. Please contact the study doctor for more specifics.
- Description of Treatment
- Participants will be randomized (like the flip of a coin) into one of three groups known as Arms. Arm 1 will take the study drug (abiraterone acetate) plus prednisone. Arm 2 will take the same as Arm 1 and in addition take degarelix. Arm 3 will take degarelix alone. The study drug and prednisone are taken in tablet form (by mouth). Degarelix is given by injection under the skin monthly. Participants will continue on the study for 8 months or until the study doctor feels it is in their best interest to stop.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
Find Related Clinical Trials
Browse by Disease Sites
Other Clinical Trials by Timothy Kuzel
- Open-Label, Multi-Center, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761 (mogamulizumab) Versus Vorinostat in Subjects with Previously Treated Cutaneous T-Cell Lymphoma
- A Randomized, Open-Label, Phase 3 Trial of brentuximab vedotin (SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous T-Cell Lymphoma
- A Phase Ib/II Trial of ALT-801 in Combination with Cisplatin and Gemcitabine in Muscle Invasive or Metastatic Urothelial Cancer
- A Randomized, Open-Label, Phase 3 Study of BMS-936558 vs. Everolimus in Subjects with Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy
- A Phase 1 Open-label Study of Safety and Tolerability of MEDI4736 in Subjects with Metastatic or Unresectable Melanoma in Combination with Dabrafenib and Trametinib or with Trametinib Alone
- A Phase 3, Randomized, Controlled Study of Cabozantinib (XL184) vs Everolimus in Subjects with Metastatic Renal Cell Carcinoma that has Progressed after Prior VEGFR Tyrosine Kinase Inhibitor Therapy
- A Randomized Phase II Trial of Sunitinib/Gemcitabine or Sunitinib in Advanced Renal Cell Carcinoma with Sarcomatoid Features
- A Phase II Trial of Dasatinib in Patients with Unresectable Locally Advanced or Stage IV Mucosal, Acral and Solar Melanomas
- Randomized, Double-Blind Phase III Study of Pazopanib vs. Placebo in Patients with Metastatic Renal Cell Carcinoma Who Have No Evidence of Disease Following Metastatectomy
- A Randomized Phase II Study of Ipilimumab at 3 mg/kg or 10 mg/kg Alone or in Combination with High Dose Interferon-a in Advanced Melanoma
- A Randomized Phase II Trial of Ipilimumab with or without Bevacizumab in Patients with Unresectable Stage III or Stage IV Melanoma
- A Randomized Phase II Study of Sequential Biotherapy with Aflibercept and High Dose IL-2 versus High Dose IL-2 alone in Patients with Inoperable Stage III or Stage IV Melanoma: Efficacy and Biomarker Study
- A Randomized Phase I Dose-Escalation Trial of Carfilzomib with and without Romidepsin in Cutaneous T-Cell Lymphoma
- Phase II Trial of Everolimus or Everolimus plus Paclitaxel as First-line Therapy in Cisplatin-ineligible Patients with Advanced Urothelial Carcinoma (GU10-147)
last updated: 20-Aug-14 07:23 PM
Clinical trial availability changes frequently. Please check this site often for updates or call 312.695.1102 for personal assistance.