Prostatic Neoplasms Clinical Trial
Official title:
The Impact of Continuous Versus Intermittent Androgen Deprivation Therapy on Bone Mineral Density Change in Prostate Cancer Patients: A Multicenter, Randomized Clinical Trial
Androgen deprivation therapy (ADT) is a mainstay of prostate cancer treatment to improve overall survival for intermediate- and high-risk localized disease as well as metastatic disease. While ADT improves survival, it can cause significant morbidity and a decrement in quality of life. In particular, ADT is associated with decrease in bone mineral density (BMD) and increased risk of fracture. Although current guidelines recommend continuous androgen deprivation therapy (CAD) as standard therapy for high-risk disease, there has been increasing recognition of adverse effects from CAD. Since 1986, intermittent androgen deprivation therapy (IAD) as alternative therapeutic strategy for prostate cancer has been proposed to delay development of castration resistance and to reduce the side effects of ADT. While both CAD and IAD are commonly used in real clinical practice, no prior study examined BMD change after CAD or IAD, and assessed whether bone loss would recover during off-treatment of IAD. The investigators therefore determine the rate of change in BMD induced by ADT (CAD versus IAD) in men with prostate cancer.
Status | Recruiting |
Enrollment | 164 |
Est. completion date | December 31, 2022 |
Est. primary completion date | April 30, 2022 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 50 Years and older |
Eligibility | Inclusion Criteria: Men aged over 50 yrs old with histologically diagnosed prostate cancer (localized, locally advanced, metastatic prostate cancer) who are treated with primary ADT for newly diagnosed prostate cancer or salvage ADT at biochemical recurrence following radical prostatectomy. . Exclusion Criteria: 1. men with double primary malignancies, 2. men who have been treated with ADT or other drug therapy such as denosumab, bisphosphonate or steroid, 3. men with osteoporosis at baseline (T-score = -2.5), 4. men with a known bone disease, 5. men with poor performance status (i.e. Eastern Cooperative Oncology Group performance status 4), 6. men with life expectancy < 12 months, 7. men with increased serum PSA levels (= 4 ng/dL) or testosterone levels (= 50 ng/dL) even after 6 month ADT, 8. men who are not able to understand trial information or informed consent, |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Department of Urology, Chungbuk National University, College of Medicine | Cheongju | |
Korea, Republic of | Department of Urology, Kyungpook National University, School of Medicine | Daegu | |
Korea, Republic of | Department of Urology, Yeungnam University, College of Medicine | Daegu | |
Korea, Republic of | Department of Urology, Eulji University, College of Medicine | Daejeon | |
Korea, Republic of | Department of Urology, Konyang University, College of Medicine, | Daejeon | |
Korea, Republic of | Department of Urology, Chonnam National University, School of Medicine | Gwangju | |
Korea, Republic of | Department of Urology, Wonkwang University, School of Medicine | Iksan | |
Korea, Republic of | Department of Urology,Jeonbuk National University Medical School | Jeonju | |
Korea, Republic of | Department of Urology, Pusan National University, School of Medicine | Pusan | |
Korea, Republic of | Department of Urology, Yonsei University Wonju College of Medicine | Wonju |
Lead Sponsor | Collaborator |
---|---|
Wonju Severance Christian Hospital | Eulji University Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of L-spine total BMD | Measured by bone densitometry | At baseline and 12 months | |
Secondary | Change of femur neck BMD | Measured by bone densitometry | At baseline and 12 months | |
Secondary | Osteoporosis | Defined as newly diagnosed osteoporosis based on T-score (= -2.5) | At 12 months | |
Secondary | Risk of 10 year major osteoporotic fracture | Estimated by Fracture Risk Assessment Tool (FRAX®, available at www.sheffield.ac.uk/FRAX) | At 12 months | |
Secondary | Quality of life after treatment | Measured by EPIC questionnaire | At baseline and 12 months |
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