Conditions: Prostate Cancer
Keywords: Androgen Deprivation Therapy Ultra-Hypofractionated SBRT 16-1686
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 56
Healthy volunteers: no

Brief summary:
Stereotactic body radiation therapy (SBRT) is a very precise form of radiation therapy that allows the physician to deliver more radiation dose in a single session. Because of this, the number of radiation sessions can be reduced from the typical 45-48 sessions, as in conventional daily session radiation, to 5 sessions given every other day over a week and a half. Giving the radiation at a higher dose during each treatment may be more effective in killing the prostate cancer cells than the standard way of using external radiation therapy where a small amount of radiation is given over many sessions.

Androgen Deprivation Therapy (ADT) or hormonal therapy is one of the methods to treat intermediate risk prostate cancer. This therapy works by reducing the level of testosterone and stopping them from affecting your cancer. The ADT used in this study is known as Degarelix. Degarelix is an approved medication that reduces the body's production of testosterone; this medication is usually given to all men with intermediate risk prostate cancer getting external radiation.

This study is a randomized study to find out whether combining stereotactic (also known as precision) radiation to the prostate cancer combined with a short course of Degarelix will result in a greater likelihood of killing the cancer in the prostate compared to stereotactic radiation therapy given alone. It has been shown that the combination of radiation with medications that interfere with testosterone production and its effects makes prostate cancer cells more sensitive to the radiation.

Detailed description:

Arms:
arm 1: Degarelix monthly for 6 months SBRT 8 Gy x 5 arm 2: SBRT 8 Gy x 5

Interventions: intervention 1: Degarelix intervention 2: stereotactic body radiosurgery (SBRT)
Intervention descriptions: intervention 1: Degarelix monthly for 6 months intervention 2: SBRT 8 Gy x 5

Protocol document:
Prot_SAP_000.pdf: