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
  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: Intervention Model: Single Group Assignment
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

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Freedom from progression at 3 years [ Time Frame: From registration to 3 years. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 80
Study Start Date: April 2008
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Androgen suppression followed by EBRT and docetaxel
Androgen suppression followed by external beam radiation therapy (EBRT) and docetaxel.
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

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528866

  Show 70 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00528866     History of Changes
Other Study ID Numbers: RTOG-0621, CDR0000563917, NCI-2009-00740
Study First Received: September 10, 2007
Last Updated: May 19, 2014
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
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
Androgens
Flutamide
Leuprolide
Goserelin
Bicalutamide
Docetaxel
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
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 July 23, 2014