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.

Doubling in number of T-cells was assessed by immunologic responses (in the tumor microenvironment) in subjects consenting to undergo study biopsies. Baseline was defined as the measurement taken within 8 weeks of prior to the first dose of study medication (Day 1).

Total of all reporting groups

Subjects received Goserelin 10.8 mg subcutaneously every 3 months for 2 years and radiation therapy lasting 6-8 weeks starting 2-3 months after ADT. In addition to the above standard treatment, subjects received tecemotide at a dose of 918 microgram (mcg) as subcutaneous injections every 2 weeks for 2 months followed by continuation treatment with 4 doses of tecemotide every 6 weeks. Subjects also received a single dose of cyclophosphamide 300 mg per square meter intra-venously 3 days before 1st administration of tecemotide.

MUC1-specific systemic immune response was measured by intracellular cytokine antigen specific staining following a period of in vitro stimulation (IVS) with overlapping 15-mer peptide pools encoding the tumor-associated antigen (TAA) MUC-1. Baseline was defined as the measurement taken prior to the first dose of study medication (Day 1).

Analysis population included only subjects who had scored positive to viral pool in peripheral blood mononuclear cells and were considered as evaluable. Here, "Number of Participants Analyzed" signifies subjects evaluable for this outcome measure.

Progression/recurrence status was reported based on Prostate-specific Antigen (PSA) Levels. Recurrence of PSA after completion of therapy represents disease progression and was determined using the American Society for Therapeutic Radiology and Oncology (ASTRO) "Phoenix criteria". These criteria define biochemical recurrence after radiation therapy as a PSA level equal to the lowest (nadir) PSA level achieved after therapy plus 2 nanogram per milliliter.

Analysis population included all subjects randomized in the study.

Doubling in number of T-cells was assessed by immunologic responses (in the tumor microenvironment) in subjects consenting to undergo study biopsies. Baseline was defined as the measurement taken within 8 weeks of prior to the first dose of study medication (Day 1).

Analysis population included only the subjects who were randomized and provided consent for biopsy and whose baseline measurement was considered as evaluable. Here, "number analyzed" signifies subjects evaluable at specified time point and "number analyzed"=0 signifies that no subjects were evaluable at the specified time point.

Subjects received Goserelin 10.8 mg subcutaneously every 3 months for 2 years and radiation therapy lasting 6-8 weeks starting 2-3 months after ADT. In addition to the above standard treatment, subjects received tecemotide at a dose of 918 microgram (mcg) as subcutaneous injections every 2 weeks for 2 months followed by continuation treatment with 4 doses of tecemotide every 6 weeks. Subjects also received a single dose of cyclophosphamide 300 mg per square meter intra-venously 3 days before 1st administration of tecemotide.