Phase II-III Trial of Adjuvant Radiotherapy Following Radical Prostatectomy With or Without Adjuvant Docetaxel

N
Nabil Adra, MD

Primary Investigator

Overview

This randomized phase II/III trial studies docetaxel, antiandrogen therapy, and radiation therapy to see how well it works compared with antiandrogen therapy and radiation therapy alone in treating patients with prostate cancer that has been removed by surgery. Androgen can cause the growth of prostate cells.

Description

The purpose of this study is to assess the benefit of docetaxel as measured by improvement in freedom from progression (phase II) and subsequently metastasis free survival (phase III) when given in combination with radiation and androgen deprivation in treatment of high risk prostate cancer post-radical prostatectomy.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    prostate cancer,prostate adenocarcinoma
  • Age: Between 18 Years - 100 Years
  • Gender: Male

Inclusion Criteria
Patients post-prostatectomy
Baseline testosterone level obtained post prostatectomy prior to step 1 registration
Pathologically (histologically) proven diagnosis of adenocarcinoma of the prostate a
Primary treatment with radical prostatectomy
Exclusion Criteria
Definitive clinical or radiologic evidence of metastatic disease
Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years) Ta bladder cancer is not considered invasive
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable if completed more than two years prior to step 1 registration; prior androgen deprivation is allowed
Prostatectomy performed greater than 365 days (1 year) prior to step 1 registration
Severe and/or active co-morbidity defined as follows:
History of inflammatory bowel disease
History of active hepatitis B or C; blood tests are not required to determine if the patient has had hepatitis B or C, unless the patient reports a history of hepatitis
Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
Transmural myocardial infarction within the last 6 months
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 1 registration
Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization within 15 days of step 1 registration or precluding study therapy at the time of step 1 registration
Uncontrolled severe illness or medical condition (including uncontrolled diabetes), which in the judgment of the treating physician would make the administration of chemotherapy inadvisable


Additional Information:
Participants will not be paid for their participation.

Updated on 19 Apr 2024. Study ID: 1712375281 (NRG-GU002)

Interested in the study?

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