Neoadjuvant Chemohormonal Therapy Followed by Salvage Surgery for High Risk PSA
The aim of this study is to test whether adding chemotherapy/cabazitaxel and hormonal/androgen deprivation therapy before surgical removal of your prostate would improve the outcome of salvage surgery for locally recurrent prostate cancer after the initial primary radiation therapy.
Drug: Androgen Ablation
Drug: Salvage Therapy
Drug: Neoadjuvant Treatment - Hormonal Therapy
Drug: Neoadjuvant Treatment - Cabazitaxel
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Neoadjuvant Chemohormonal Therapy Followed by Salvage Surgery for High Risk PSA Failure With Biopsy Proven Local Recurrence After Initial Definitive Radiotherapy|
- Surgical Margin Negative Rate (SM Rate) [ Time Frame: On study through end of follow-up - up to 10 years ] [ Designated as safety issue: No ]To determine the surgical margin negative rate in patients who have undergone chemohormonal therapy followed by surgery for biopsy proven androgen-dependent high risk locally recurrent prostate cancer following primary radiation therapy.
- Incidence of PSA Progression Free Survival (PFS) [ Time Frame: On study through end of follow-up - up to 10 years ] [ Designated as safety issue: No ]To assess Prostate-specific antigen(PSA)-progression free survival and prostate cancer specific survival for patients treated by chemohormonal therapy followed by salvage surgery for biopsy proven androgen-dependent high-risk locally recurrent prostate cancer following radiation therapy.
- Incidence of Complete Response (CR) [ Time Frame: On study through end of follow-up - up to 10 years ] [ Designated as safety issue: No ]To evaluate the pathological complete response rate to androgen ablation plus Cabazitaxel in patients with locally recurrent prostate cancer following radiation therapy.
- Incidence of Perioperative and Postoperative Morbidity [ Time Frame: On study through end of follow-up - up to 10 years ] [ Designated as safety issue: Yes ]To access the perioperative and postoperative morbidity with salvage surgery after neoadjuvant hormonal ablation and Cabazitaxel.
- Incidence of Detecting Circulating Tumor Cells (CTC) [ Time Frame: On study through end of follow-up - up to 10 years ] [ Designated as safety issue: No ]To determine the feasibility of detecting circulating tumor cells in this patient population.
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||April 2022|
|Estimated Primary Completion Date:||April 2022 (Final data collection date for primary outcome measure)|
Experimental: Drug and Hormonal Therapy with Salvage Surgery
Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
Drug: Androgen Ablation
All patients will receive luteinizing hormone-releasing hormone (LHRH) agonist therapy (leuprolide or goserelin acetate) concurrent with Cabazitaxel, before surgery. A course of bicalutamide 50 mg daily orally for 14-21 days is recommended for patients starting LHRH agonist therapy and suspected to be at risk for tumor flare, e.g., significant obstructive urinary symptoms and will be optional in other patients.
Other Names:Drug: Cabazitaxel
Intravenous treatment with Cabazitaxel 25 mg/m^2 is given on day 1 every 21 days. A cycle of chemotherapy will be defined as 21 days. A total of four cycles of combination therapy are planned for a total duration of 12 weeks (before surgery), starting within 3 weeks of protocol entry, to be given concurrent with hormone therapy.
Other Name: Jevtana®Drug: Salvage Therapy
Patients will undergo 4 cycles of chemotherapy in conjunction with LHRH agonist therapy (before surgery) subsequent to which they will have their serum Prostate-specific antigen (PSA), bone scan, abdominal pelvic computed tomography (CT) or magnetic resonance imaging (MRI) repeated. Patients with a detectable metastatic diseases will be removed from the study. Salvage surgery will be performed within 8 weeks after the completion of Cabazitaxel chemotherapy. For patients who achieved undetectable PSA following surgery, androgen deprivation therapy will be discontinued.
Other Name: prostatectomyDrug: Neoadjuvant Treatment - Hormonal Therapy
All treatment will be given on an outpatient basis. Treatment should start within 3 weeks of protocol entry. All patients will receive androgen ablation with LHRH agonist therapy in conjunction with the 4 cycles of Cabazitaxel for neoadjuvant chemohormonal therapy. Androgen ablative therapy will be discontinued before surgery. A course of bicalutamide 50 mg daily orally for 14-21 days is recommended for patients starting LHRH agonist therapy and suspected to be at risk for tumor flare, e.g., significant obstructive urinary symptoms and will be optional in other patients.Drug: Neoadjuvant Treatment - Cabazitaxel
All treatment will be given on an outpatient basis and should start within 3 weeks of protocol entry. Intravenous treatment with Cabazitaxel is given on Day 1 every 3 weeks. A cycle of combination therapy will be defined as 3 weeks. A total of 4 cycles of combination therapy are planned before surgery for a total duration of 12 weeks.
Cabazitaxel will be administered before surgery by one-hourly infusions via central or peripheral intravenous access at a dose of 25 mg/m^2 as a one hour intravenous infusion in combination with oral prednisone 10 mg administered daily throughout Cabazitaxel treatment. It is advised that all patients receiving Cabazitaxel have a reliable form of venous access, e.g., central venous catheter to ensure their ability to receive therapy without undue delay.
Other Name: Jevtana®
In this study, all participants will receive cabazitaxel chemotherapy, which is approved as a second line chemotherapy for treating metastatic prostate cancer. Standard hormone or androgen ablation therapy will also be used as part of the chemohormonal therapy prior to the surgery.
|Contact: Julio Pow-Sang, M.D.||firstname.lastname@example.org|
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Inez Sims 813-745-3982 email@example.com|
|Principal Investigator: Julio Pow-Sang, M.D.|
|Sub-Investigator: Mayor Fishman, M.D., Ph.D.|
|Sub-Investigator: Shilpa Gupta, M.D.|
|Sub-Investigator: Julie Kish, M.D.|
|Sub-Investigator: Sandhya Rao, M.D.|
|Sub-Investigator: Wade Sexton, M.D.|
|Sub-Investigator: Philippe Spiess, M.D.|
|Sub-Investigator: Jingsong Zhang, M.D., Ph.D.|
|Principal Investigator:||Julio Pow-Sang, M.D.||H. Lee Moffitt Cancer Center and Research Institute|