SURGICAL DEBULKING OF PITUITARY ADENOMAS & RESPONSIVENESS TO OCTREOTIDE LAR

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Acromegaly is a rare but debilitating disease caused by a pituitary tumor. Current therapeutic options are extremely limited. This protocol compares medical treatment alone to surgery followed by medical treatment to determine which method best controls IGF-1, a key indicator of disease activity. Adult subjects with a diagnosis of acromegaly who are scheduled to receive pituitary adenoma debulking surgery may be eligible. Subjects will be randomized into one of two arms. Randomly means by chance, like flipping a coin. The first group will delay scheduled surgery for 3 months and receive medical treatment with FDA-approved medication Sandostatin LAR during that time. The second group will receive surgery immediately. Those who continue to show disease activity after surgery will then receive medical treatment with Sandostatin LAR for three months. Sandostatin LAR (also called Octreotide LAR) is a medication approved by the Food and Drug Administration (FDA). It is similar to, but more effective than somatostatin, which is a naturally occurring hormone that inhibits the release of growth hormone (GH) from the pituitary gland. This study is being done to find out if surgery helps Sandostatin work, to improve treatment options for people with acromegaly. Study procedures include MRI, EKG, OGTT, blood draws, physical examination, and patient assessments to evaluate disease activity. The primary measure used to determine whether pituitary surgery improves the response to Sandostatin LAR is levels of IGF-1, a substance that is an important indicator of acromegaly disease activity.'