Radiation Therapy, Androgen Suppression, and Docetaxel in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy
RATIONALE: Specialized radiation therapy that delivers a high-dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide, goserelin, flutamide, or bicalutamide, may lessen the amount of androgens made by the body. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with androgen suppression and docetaxel after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving radiation therapy together with androgen suppression and docetaxel works in treating patients with high risk prostate cancer who have undergone radical prostatectomy.
Drug: goserelin acetate
Drug: leuprolide acetate
Procedure: adjuvant therapy
Radiation: 3-dimensional conformal radiation therapy
Radiation: intensity-modulated radiation therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Adjuvant 3DCRT/IMRT in Combination With Androgen Suppression and Docetaxel for High Risk Prostate Cancer Patients Post-Prostatectomy: A Phase II Trial|
- Freedom from progression at 2 years [ Designated as safety issue: No ]
- Freedom from local-regional progression [ Designated as safety issue: No ]
- Distant metastasis [ Designated as safety issue: No ]
- Prostate cancer specific survival [ Designated as safety issue: No ]
- Non-prostate cancer specific survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Time to biochemical (PSA) failure [ Designated as safety issue: No ]
- Treatment-related "acute" and "late" toxicity based on CTCAE v3.0 [ Designated as safety issue: Yes ]
- Prognostic value of genomic and proteomic biomarkers for the primary and secondary clinical endpoints [ Designated as safety issue: No ]
|Study Start Date:||April 2008|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
- To assess whether the addition of androgen suppression therapy and docetaxel to adjuvant radiotherapy improves freedom from progression.
- To assess freedom from local-regional progression, distant metastases, disease-free survival, prostate cancer specific survival, non-prostate cancer specific survival, overall survival, and time to biochemical (PSA) failure.
- To evaluate treatment-related "acute" and "late" toxicity based on CTCAE v3.0.
- To correlate genomic and proteomic biomarkers with the primary and secondary clinical endpoints utilizing archival prostatectomy tissue and pretreatment and prospectively collected serum/plasma.
OUTLINE: This is a multicenter study.
- Androgen suppression therapy: Patients receive a luteinizing hormone-releasing hormone (LHRH) agonist (leuprolide or goserelin) as an injection AND an oral antiandrogen (flutamide 3 times daily or bicalutamide once daily) for up to 6 months.
- Radiotherapy: Beginning 8 weeks after the initiation of androgen suppression therapy, patients undergo 3-dimensional conformal radiotherapy or intensity-modulated radiotherapy once a day 5 days a week for up to approximately 8 weeks.
- Chemotherapy: Beginning 3-6 weeks after the completion of radiotherapy, patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 courses.
After the completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
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|Study Chair:||Mark Hurwitz, MD||Dana-Farber/Brigham and Women's Cancer Center|
|Investigator:||Oliver Sartor, MD||Dana-Farber Cancer Institute|
|Investigator:||Ying Xiao, PhD||Bodine Center for Cancer Treatment at Thomas Jefferson University Hospital|