Androgen Deprivation Therapy on Bone Mineral Density Change in Prostate Cancer Patients

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04248621
• Other study ID #: EMC 2019-12-003-001
• Status: Recruiting
• Phase: Phase 4
• Start date: January 23, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2021
• Source: Wonju Severance Christian Hospital
• Contact: Jinsung Park, MD. PhD.
• Phone: +82426113533
• Email: jspark.uro[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Objective: To determine the rate of bone mass loss induced by two therapeutic strategies of ADT (CAD versus IAD) in men with prostate cancer. Design, setting, and participants: the investigators will perform randomized, open label clinical trial. Men aged over 50 yrs old with 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 will be included. Participants will be randomly assigned to one of the following treatment arms: Arm 1 (CAD): ADT without any discontinuation during study period (12 months). Arm 2 (IAD): ADT for the first 6 months of study period, if the prostate-specific antigen (PSA) reaches its nadir (< 4 ng/dL) and serum testosterone reaches castration level (< 50 ng/dL). Outcomes: Primary outcome: change of L-spine total BMD. Secondary outcomes: change of femur neck BMD, incidence rate of osteoporosis, risk of 10 year major osteoporotic fracture, quality of life based on Expanded Prostate Cancer Index (EPIC) questionnaire. Timing of outcome measurement: at baseline and up to 12 months after randomization. Statistical analyses: student's t test for continuous outcomes and Fisher's exact or chi-square test for dichotomous outcomes.

Recruitment information / eligibility

• 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,

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Drug:
• Leuprorelin
LHRH agonist
• Goserelin
LHRH agonist
• Triptorelin
LHRH agonist
• Degarelix
LHRH antagonist
• Bicalutamide
Antiandrogen
• Flutamide
Antiandrogen
• Maximum androgen blockade
Combination therapy with LHRH agonist and antiandrogen

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Wonju Severance Christian Hospital	Eulji University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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