NCT03070886

Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 612 (actual)
• Sponsor: NRG Oncology · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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. Antihormone therapy may lessen the amount of androgen made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving antiandrogen therapy and radiation therapy with or without docetaxel after surgery may kill any remaining tumor cells.

Detailed description

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.

Conditions

• Stage I Prostate Adenocarcinoma AJCC v7
• Stage II Prostate Adenocarcinoma AJCC v7
• Stage III Prostate Adenocarcinoma AJCC v7

Interventions

Type	Name	Description
DRUG	Bicalutamide	Given orally (PO)
DRUG	Degarelix	Given IM
DRUG	Docetaxel	Given IV
RADIATION	External Beam Radiation Therapy	Undergo external beam radiation therapy
DRUG	Flutamide	Given PO
DRUG	Goserelin	Given IM
DRUG	Goserelin Acetate	Given IM
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Leuprolide	Given intramuscularly (IM)
DRUG	Leuprolide Acetate	Given IM
DRUG	Nilutamide	Drug

Timeline

• Start date: 2017-04-05
• Primary completion: 2025-10-31
• Completion: 2025-10-31
• First posted: 2017-03-06
• Last updated: 2026-01-14

Locations

313 sites across 3 countries: United States, Canada, Puerto Rico