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Adjuvant 3DCRT/IMRT in Combination With Androgen Suppression and Docetaxel for High Risk Prostate Cancer Patients Post-Prostatectomy: A Phase II Trial

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Trial Conditions
  • Prostate Cancer
What is the purpose of this 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.

Date & Status

Active, not recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Male

Eligibility

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

Gender: Male
Steward Physician(s)
  • Mark Hurwitz, MD
  • Oliver Sartor, MD
  • Ying Xiao, PhD
Facilities
  • Saint Anne's Hospital - Active, not recruiting
Trial Interventions
Drug
  • bicalutamide
  • docetaxel
  • flutamide
  • goserelin acetate
  • leuprolide acetate
Procedure
  • adjuvant therapy
Radiation
  • 3-dimensional conformal radiation therapy
  • intensity-modulated radiation therapy
Physician Researcher

Investigator Name:

  • Mark Hurwitz, MD
  • Oliver Sartor, MD
  • Ying Xiao, PhD

Other Information

Sponsor: Radiation Therapy Oncology Group
Phase: Phase 2
Trial ID: NCT00528866
Volunteers:  Not Accepting Healthy Volunteers

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