At a glance
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A Randomized Phase II Study of Tecemotide in Combination With Standard Androgen Deprivation Therapy and Radiation Therapy for Untreated, Intermediate and High Risk Prostate Cancer Patients
In Brief
A Phase 2 clinical trial evaluating Radiation therapy, Goserelin, and 2 other interventions for Prostate Cancer. Completed, enrolled 28 participants across 1 site.
Detailed Summary
This study examines tecemotide (L-BLP25) in combination with standard treatment for prostate cancer.
Study Details
Timeline
Interventions
Radiation therapy will be administered at a daily dose of 180 centigrays (cGy) 5 days a week for approximately 6 to 8 weeks.
ADT (Goserelin) will be administered at a dose of 10.8 milligrams (mg) subcutaneously every 3 months for 24 months for the high risk group and for 6 months in the intermediate risk group, starting 2-3 months prior to radiation therapy.
Cyclophosphamide will be administered at a single dose of 300 milligrams per square meter (mg/m\^2) to a maximum of 600 mg, as an intravenous injection 3 days prior to the first administration of tecemotide (L-BLP25).
Tecemotide (L-BLP25) will be administered at a dose of 918 microgram (mcg) as subcutaneous injection every 2 weeks for 5 doses followed by every 6 weeks for an additional 4 doses, starting 2-3 months prior to radiation therapy and on the same day that ADT began.