Clinical trial · Interventional
Androgen Deprivation Therapy on Bone Mineral Density Change in Prostate Cancer Patients
The Impact of Continuous Versus Intermittent Androgen Deprivation Therapy on Bone Mineral Density Change in Prostate Cancer Patients: A Multicenter, Randomized Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bicalutamide | Drug | Bicalutamide | ALIAS |
| Degarelix | Drug | Degarelix | ALIAS |
| Flutamide | Drug | Flutamide | ALIAS |
| Goserelin | Drug | Goserelin | ALIAS |
| Leuprorelin | Drug | Leuprolide | ALIAS |
| Maximum androgen blockade | Drug | — | UNRESOLVED |
| Triptorelin | Drug | Triptorelin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intermittent Androgen Deprivation
- description
- 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).
- interventionNames
- Drug: Leuprorelin
- Drug: Goserelin
- Drug: Triptorelin
- Drug: Degarelix
- Drug: Bicalutamide
- Drug: Flutamide
- Drug: Maximum androgen blockade
- type
- ACTIVE_COMPARATOR
- label
- Continuous Androgen Deprivation
- description
- ADT including LHRH agonist and antagonist, antiandrogen, or MAB without any discontinuation during study period.
- interventionNames
- Drug: Leuprorelin
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
Show eligibility criteria text
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,
References
Publications (0)
Data not yet available