Conditions: Prostate Cancer
Keywords: Tecemotide Prostate Cancer Goserelin Cyclophosphamide Radiotherapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 28
Healthy volunteers: no

Brief summary:
This study examines tecemotide (L-BLP25) in combination with standard treatment for prostate cancer.

Detailed description:

Arms:
arm 1: Radiation therapy in combination with androgen deprivation therapy (ADT). arm 2: Standard therapy (radiation therapy in combination with ADT) plus tecemotide (L-BLP25).

Interventions: intervention 1: Radiation therapy intervention 2: Goserelin intervention 3: Cyclophosphamide intervention 4: Tecemotide (L-BLP25)
Intervention descriptions: intervention 1: Radiation therapy will be administered at a daily dose of 180 centigrays (cGy) 5 days a week for approximately 6 to 8 weeks. intervention 2: 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. intervention 3: 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). intervention 4: 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.

Protocol document: