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

NCT04248621 | Unknown Phase 4

• 1 other identifier: EMC 2019-12-003-001
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Prostatic Neoplasms

Keywords

Androgen Antagonists; Bone Density; Prostatic Neoplasms

Outcome Measures

Primary Outcomes (1)

• Change of L-spine total BMD

  Measured by bone densitometry

  At baseline and 12 months

Secondary Outcomes (4)

• Change of femur neck BMD

  At baseline and 12 months

• Osteoporosis

  At 12 months

• Risk of 10 year major osteoporotic fracture

  At 12 months

• Quality of life after treatment

  At baseline and 12 months

Study Arms (2)

Intermittent Androgen Deprivation

EXPERIMENTAL

ADT including luteinizing hormone-releasing hormone (LHRH) agonist and antagonist, antiandrogen, or maximum androgen blockade (MAB) should be withdrawn after 6 months of ADT, if the prostate-specific antigen (PSA) reaches its nadir (\< 4 ng/dL) and serum testosterone reaches castration level (\< 50 ng/dL).

Drug: Leuprorelin; Drug: Goserelin; Drug: Triptorelin; Drug: Degarelix; Drug: Bicalutamide; Drug: Flutamide; Drug: Maximum androgen blockade

Continuous Androgen Deprivation

ACTIVE COMPARATOR

ADT including LHRH agonist and antagonist, antiandrogen, or MAB without any discontinuation during study period.

Drug: Leuprorelin; Drug: Goserelin; Drug: Triptorelin; Drug: Degarelix; Drug: Bicalutamide; Drug: Flutamide; Drug: Maximum androgen blockade

Interventions

Leuprorelin DRUG

LHRH agonist

Also known as: Leuprorelin acetate

Continuous Androgen Deprivation; Intermittent Androgen Deprivation

Goserelin DRUG

LHRH agonist

Also known as: Goserelin acetate

Continuous Androgen Deprivation; Intermittent Androgen Deprivation

Triptorelin DRUG

LHRH agonist

Also known as: Triptorelin acetate

Continuous Androgen Deprivation; Intermittent Androgen Deprivation

Degarelix DRUG

LHRH antagonist

Also known as: Degarelix acetate

Continuous Androgen Deprivation; Intermittent Androgen Deprivation

Bicalutamide DRUG

Antiandrogen

Also known as: Casodex

Continuous Androgen Deprivation; Intermittent Androgen Deprivation

Flutamide DRUG

Antiandrogen

Also known as: Niftolide

Continuous Androgen Deprivation; Intermittent Androgen Deprivation

Maximum androgen blockade DRUG

Combination therapy with LHRH agonist and antiandrogen

Also known as: LHRN agonist and antiandrogen

Continuous Androgen Deprivation; Intermittent Androgen Deprivation

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. .

You may not qualify if:

• men with double primary malignancies,
• men who have been treated with ADT or other drug therapy such as denosumab, bisphosphonate or steroid,
• men with osteoporosis at baseline (T-score ≤ -2.5),
• men with a known bone disease,
• men with poor performance status (i.e. Eastern Cooperative Oncology Group performance status 4),
• men with life expectancy \< 12 months,
• men with increased serum PSA levels (≥ 4 ng/dL) or testosterone levels (≥ 50 ng/dL) even after 6 month ADT,
• men who are not able to understand trial information or informed consent,

Sponsors & Collaborators

• Wonju Severance Christian Hospital: lead
• Eulji University Hospital: collaborator

Study Sites (10)

Department of Urology, Chungbuk National University, College of Medicine

Cheongju-si, South Korea

RECRUITING

Department of Urology, Kyungpook National University, School of Medicine

Daegu, South Korea

RECRUITING

Department of Urology, Yeungnam University, College of Medicine

Daegu, South Korea

RECRUITING

Department of Urology, Eulji University, College of Medicine

Daejeon, South Korea

RECRUITING

Department of Urology, Konyang University, College of Medicine,

Daejeon, South Korea

RECRUITING

Department of Urology, Chonnam National University, School of Medicine

Gwangju, South Korea

RECRUITING

Department of Urology, Wonkwang University, School of Medicine

Iksan, South Korea

RECRUITING

Department of Urology,Jeonbuk National University Medical School

Jeonju, South Korea

RECRUITING

Department of Urology, Pusan National University, School of Medicine

Pusan, South Korea

RECRUITING

Department of Urology, Yonsei University Wonju College of Medicine

Wŏnju, South Korea

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Leuprolide; Goserelin; Triptorelin Pamoate; acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide; bicalutamide; Flutamide; Androgen Antagonists

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Jinsung Park, MD. PhD.

  Department of Urology, Eulji University, College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinsung Park, MD. PhD.

CONTACT

+82426113533; jspark.uro@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 30, 2020
• Study Start: January 23, 2020
• Primary Completion: April 30, 2022
• Study Completion: December 31, 2022
• Last Updated: July 29, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (10)