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Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government.

Read our disclaimer for details. Results First Posted : June 19, Last Update Posted : October 19, Study Description. The purpose of this study is to evaluate the efficacy and safety of apalutamide in adult men with high-risk non-metastatic castration-resistant prostate cancer. Detailed Description:.

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Study participants will be randomly like flipping a coin assigned to one of these groups: One group will receive their current treatment along with the investigational medication One group will receive their current medications along with a placebo The investigational medication will be given to 2 out of every 3 study participants. Drug Information available for: Apalutamide. FDA Resources.

Arms and Interventions. Matched placebo tablets administered by mouth on a continuous once daily dosing regimen. Outcome Measures.

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Time to symptomatic progression was defined as the time from randomization to documentation in the CRF of any of the following whichever occurred earlier : a development of a skeletal-related event pathologic fracture, spinal cord compression, or need for surgical intervention or radiation therapy to the bone ; b pain progression or worsening of disease-related symptoms requiring initiation of a new systemic anti-cancer therapy; or c development of clinically significant symptoms due to loco-regional tumor progression requiring surgical intervention or radiation therapy.

Overall survival was defined as the time from randomization to the date of death due to any cause. Time to initiation of cytotoxic chemotherapy was defined as the time from randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.

Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. Clinical Trial Aragon Pharmaceuticals, Inc. More Information. June 28, September 16, January 23, September 9, April 21, July 13, March 8, March 9, March 12, January 6, Study Status Record Verification:.

FDA-regulated Drug:. Study Description Brief Summary:. This study is designed as a phase III, randomized, double-blind, placebo-controlled trial to explore the effect of maintenance therapy with lenalidomide versus placebo on progression-free survival PFS in patients treated with R-CHOP responding to induction therapy For the primary efficacy variable, PFS, an improvement in median PFS from Conditions Conditions:.

Study Design Study Type:. Placebo Comparator: Placebo Placebo daily for 3 weeks every 4 weeks for 24 months. Outcome Measures Primary Outcome Measures:. Response rate at the end of maintenance treatment From randomization to the end of the 24 months maintenance.

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Average of 74 months. Select an option below to see step-by-step directions and to compare ticket prices and travel times in Rome2rio's travel planner. Domestic travel is not restricted, but some conditions may apply Face masks are mandatory There is a social distancing requirement of 1.

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Last updated: 15 Nov Exceptions may apply, for full details: European Union. This information is compiled from official sources. To the best of our knowledge, it is correct as of the last update.

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Services depart hourly, and operate every day. The journey takes approximately 35 min.

The distance between Ottignies-Louvain-la-Neuve and Gilly is 28 km. The road distance is Get driving directions. Yes, the driving distance between Ottignies-Louvain-la-Neuve to Gilly is 47 km.

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It takes approximately 31 min to drive from Ottignies-Louvain-la-Neuve to Gilly. Rome2rio's Travel Guide series provide vital information for the global traveller.