Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
NRG Oncology
With
PRIMARY OBJECTIVE: I. 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. SECONDARY OBJECTIVES: I. To assess overall survival. II. To assess local time to progression. III. To assess undetectable prostate-specific antigen (PSA) with a non-castrate testosterone at 2.5 years post treatment. IV. To assess the utility of genomic profiling in making adjuvant therapy decisions post-prostatectomy. V. To assess toxicity of docetaxel in the post-operative setting when combined with radiation and androgen deprivation therapy. VI. To assess treatment response by genomically defined sub-groups of prostate cancer patients. EXPLORATORY OBJECTIVE: I. To optimize quality assurance methodologies and processes for radiotherapy and imaging, with machine learning strategies. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive androgen deprivation therapy comprising leuprolide acetate, goserelin acetate, degarelix, bicalutamide, flutamide, or nilutamide for 6 months. Beginning 8 weeks after the start of androgen deprivation therapy, patients receive external beam radiation therapy (EBRT) for 7.5 weeks. ARM II: Patients receive androgen deprivation therapy and EBRT as in Arm I. Within 4-6 weeks after completion of radiation therapy, patients receive docetaxel intravenously (IV) over 1 hour on day 1 of every 21 days for 6 cycles in the absence of disease progression or unexpected toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years, then every 6 months for 3 years, and then yearly.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
