Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments bicalutamide, docetaxel, flutamide, goserelin acetate, leuprolide acetate, adjuvant therapy, 3-dimensional conformal radiation therapy, intensity-modulated radiation therapy
Phase phase 2
Sponsor Radiation Therapy Oncology Group
Collaborator National Cancer Institute (NCI)
Start date April 2008
End date December 2013
Trial size 80 participants
Trial identifier NCT00528866, CDR0000563917, NCI-2009-00740, RTOG-0621

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Androgen suppression followed by external beam radiation therapy (EBRT) and docetaxel.
bicalutamide
docetaxel
flutamide
goserelin acetate
leuprolide acetate
adjuvant therapy
3-dimensional conformal radiation therapy
intensity-modulated radiation therapy

Primary Outcomes

Measure
Freedom from progression at 3 years
time frame: From registration to 3 years.

Secondary Outcomes

Measure
Local-regional progression
time frame: From registration to date of failure (local progression) or death or last follow-up. Analysis occurs at the same time as the primary endpoint.
Distant metastasis
time frame: From registration to date of failure (distant metastasis) or death or last follow-up. Analysis occurs at the same time as the primary endpoint.
Prostate cancer specific survival
time frame: From registration to date of failure (death due to prostate cancer) or death due to other causes or last follow-up. Analysis occurs at the same time as the primary endpoint.
Non-prostate cancer specific survival
time frame: From registration to date of failure (death due to other causes) or death due to prostate cancer or last follow-up. Analysis occurs at the same time as the primary endpoint.
Overall survival
time frame: From registration to date of failure (death) or last follow-up. Analysis occurs at the same time as the primary endpoint.
Time to biochemical (PSA) failure
time frame: From registration to date of failure (PSA ≥ 4.0 confirmed by a second higher PSA, or non-protocol hormones) or death or last follow-up. Analysis occurs at the same time as the primary endpoint.
Grade 3 and late adverse events
time frame: From 121 days to 751 days after the end of treatment.

Eligibility Criteria

Male participants at least 18 years old.

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 pathologic tumor (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 - Absolute neutrophil count (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) - Alanine aminotransferase (ALT) and aspartate aminotransferase (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 dutasteride, 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

Additional Information

Official title Adjuvant 3DCRT/IMRT in Combination With Androgen Suppression and Docetaxel for High Risk Prostate Cancer Patients Post-Prostatectomy: A Phase II Trial
Principal investigator Mark Hurwitz, MD
Description 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 Common Toxicity Criteria for Adverse Effects (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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Radiation Therapy Oncology Group.