Radiation Therapy, Androgen Suppression, and Docetaxel in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: bicalutamide Drug: docetaxel Drug: flutamide Drug: goserelin acetate Drug: leuprolide acetate Procedure: adjuvant therapy Radiation: 3-dimensional conformal radiation therapy Radiation: intensity-modulated radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| 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 ]
| Estimated Enrollment: | 76 |
| Study Start Date: | April 2008 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- To assess whether the addition of androgen suppression therapy and docetaxel to adjuvant radiotherapy improves freedom from progression.
Secondary
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Pathologically proven adenocarcinoma of the prostate cancer meeting 1 of the following criteria:
- Gleason ≥ 7and post-operative PSA nadir > 0.2 ng/ml with any pT classification
- Gleason ≥ 8, post-operative PSA nadir ≤ 0.2 ng/ml and ≥ pT3a classification
- Must have undergone radical prostatectomy within the past year
PSA ≤ 0.2 ng/mL at the time of study registration
- PSA must be obtained within 6 weeks (42 days) prior to study registration
No lymph node or distant metastases (N0, M0), based upon the following minimum diagnostic workup:
- History and physical examination within 8 weeks prior to study registration
- Bone scan and CT or MRI of the pelvis and no evidence of osseous metastases on bone scan within 16 weeks prior to study registration
- No pelvic lymph nodes > 1.5 cm in greatest dimension on CT scan or MRI of the pelvis within 16 weeks prior to study registration, unless the enlarged lymph node is biopsied and negative
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-1
- ANC ≥ 2,000/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve hemoglobin ≥ 8.0 g/dL is acceptable)
- ALT and AST ≤ 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN
- Total bilirubin ≤ 1.2 times ULN
- No other invasive malignancy within the past 3 years except non-melanomatous skin cancer
No active, severe co-morbidity, including any of the following:
- Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
- Transmural myocardial infarction within the past 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy
AIDS
- HIV testing is not required for study entry
- No prior allergic reaction to the study drug(s)
PRIOR CONCURRENT THERAPY:
- No prior systemic chemotherapy for prostate cancer
- More than 3 years since prior chemotherapy for a different cancer
No prior androgen deprivation for treatment of prostate cancer
- Prior use of hormonal agents, such as finasteride or dutaseride, for treatment of benign prostatic hypertrophy is allowed
- No prior radiotherapy to the region of the prostate that would result in overlap of radiotherapy fields
Contacts and Locations
Show 70 Study Locations| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Walter John Curran, Jr, Radiation Therapy Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00528866 History of Changes |
| Other Study ID Numbers: | CDR0000563917, RTOG-0621 |
| Study First Received: | September 10, 2007 |
| Last Updated: | August 3, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adenocarcinoma of the prostate stage IIB prostate cancer stage IIA prostate cancer stage III prostate cancer stage IV prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Adjuvants, Immunologic Androgens Flutamide Leuprolide Goserelin Bicalutamide Docetaxel |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Androgen Antagonists Hormone Antagonists Fertility Agents, Female Fertility Agents Reproductive Control Agents |
ClinicalTrials.gov processed this record on May 16, 2013