Meeting Abstract

JL303. Local Observational Study of Supportive Care, Treatment and Bone Health in Prostate Cancer Patients Receiving Androgen Deprivation Therapy (LOSST trial)

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ABSTRACT

Background: Advanced practice nurses (APRNs) caring for prostate cancer patients in a community setting noted that bone health was not being monitored in patients receiving ADT. A review of published articles in early 2011 revealed little attention to the topic so a study was designed, then approved by the local IRB, the first initiated by an all APRN group. Purpose: To determine if attention to bone health in prostate cancer patients on ADT reduced the incidence of skeletal related events (SRE), loss of BMD and/or affected progression of disease determined by measurement of prostate specific antigen (PSA). Sample: A convenience sample of men 18 years or older in a community urology clinic with non-metastatic prostate cancer with planned ADT for at least one year.

Methods: Patients were approached during routine visits to the urology clinic regarding participation. Baseline vitamin D and bone mineral density (BMD) study with DEXA scan were performed on all participants. Subjects were managed by a protocol for vitamin D supplementation and/or treatment of osteopenia/osteoporosis as needed. DEXA scan was repeated at two years. PSA was also monitored at least twice per year. A total of 28 men were enrolled and divided into 3 groups. Group 1 (2 men) received bisphosphonate plus vitamin D, Group 2 (17 men) received Vitamin D and calcium supplementation only, Group 3 (9 men) received standard of care. Additional data collected included age, weight/body mass index (BMI), Gleason score, smoking history, and reporting of SREs. Results: Group 1 – Bisphosphonate plus vitamin D-both men 2/2 (100%) showed increased BMD at two years. One/2 (50%) developed bone metastasis during the study. Group 2 – Vitamin D/calcium treatment alone-showed 3/17 (17.6%) with increased BMD, 14/17 (82%) had decreased BMD (> 3%) at 2 years. Four/17 (23.5%) developed bone metastasis, one died as a result of his disease. Group 3 showed 1/9 (11%) with increased BMD and 8/9 (89%) decreased. One/9 men developed bone metastasis, 1/9 (11%) developed a second primary. Three/28 (11%) men had increase in PSA. Target vitamin D levels were achieved in 9/28 (32%) subjects. Three/9 (33%) of those who reached the therapeutic vitamin D level developed bone metastasis. One/28 (4%) did not complete the second vitamin D screening.

Conclusions: The addition of bisphosphonates and vitamin D to ADT treatment may improve BMD; the effect on delay/prevention of development of SREs is unknown. More attention to vitamin D supplementation could be helpful in maintaining or improving BMD in patients on ADT. Implications/Significance: Limited enrollment did not allow for a statistically significant result, however, this is useful data as a pilot study. The study was helpful in the development of a protocol for assessment of vitamin D and BMD in the urology clinic and improved care of patients.

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