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Radiation Therapy, Androgen Suppression, and Docetaxel in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00528866
First received: September 10, 2007
Last updated: May 19, 2014
Last verified: May 2014

September 10, 2007
May 19, 2014
April 2008
September 2013   (final data collection date for primary outcome measure)
Freedom from progression at 3 years [ Time Frame: From registration to 3 years. ] [ Designated as safety issue: No ]
Freedom from progression at 2 years
Complete list of historical versions of study NCT00528866 on ClinicalTrials.gov Archive Site
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Grade 3 and late adverse events [ Time Frame: From 121 days to 751 days after the end of treatment. ] [ Designated as safety issue: Yes ]
  • Freedom from local-regional progression
  • Distant metastasis
  • Prostate cancer specific survival
  • Non-prostate cancer specific survival
  • Overall survival
  • Time to biochemical (PSA) failure
  • Treatment-related "acute" and "late" toxicity based on CTCAE v3.0
  • Prognostic value of genomic and proteomic biomarkers for the primary and secondary clinical endpoints
Not Provided
Not Provided
 
Radiation Therapy, Androgen Suppression, and Docetaxel in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy
Adjuvant 3DCRT/IMRT in Combination With Androgen Suppression and Docetaxel for High Risk Prostate Cancer Patients Post-Prostatectomy: A Phase II Trial

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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Experimental: Androgen suppression followed by EBRT and docetaxel
Androgen suppression followed by external beam radiation therapy (EBRT) and docetaxel.
Interventions:
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
Not Provided
September 2013   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00528866
RTOG-0621, CDR0000563917, NCI-2009-00740
Yes
Radiation Therapy Oncology Group
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Mark Hurwitz, MD Thomas Jefferson University and Hospitals
Study Chair: Oliver Sartor, MD Dana-Farber Cancer Institute
Study Chair: Ying Xiao, PhD Bodine Center for Cancer Treatment at Thomas Jefferson University Hospital
Radiation Therapy Oncology Group
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP