Trial · NCT03336983
Luteinizing Hormone-releasing Hormone Analogue and Enzalutamide +/- Zoledronic Acid in Prostate Cancer Patients
NCT03336983, Phase 2, Completed, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Luteinizing Hormone-releasing Hormone Analogue and Enzalutamide +/- Zoledronic Acid in Prostate Cancer Patients. Trials, record NCT03336983. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03336983
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Luteinizing Hormone-releasing Hormone Analogue and Enzalutamide +/- Zoledronic Acid in Prostate Cancer Patients
- NCT number
- NCT03336983
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 126 participants, actual
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Conditions
- Prostate Cancer, Bone Metastases
- Interventions
- Zoledronic Acid, Enzalutamide
- First posted
- 2017-11-08
- Last updated
- 2024-08-01
- Other registries' IDs
- eudract:2017-000305-21
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluation of change in bone response after 6 and 12 months of treatment compared to baseline | Exam will be performed at baseline and after 6 and 12 months of treatment | Whole-body Diffusion MRI |
| Secondary | Evaluation of bone repair | Screening visit; 12 months of treatment | CT Scan |
| Secondary | Changes in bone mineral density after 18 months of treatment compared to baseline | Screening visit; 18 months of treatment | Dual energy x-ray absorptiometry (DEXA Scan) |
| Secondary | Functional Assessment of Cancer Therapy-Prostate | Monthly until end of treatment (18 months) | Functional Assessment of Cancer Therapy-Prostate (FACT- P) Questionnaire will be collected from patients.It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce subscale scores for each domain, as well as a global Qquality of Life (QoL) score. |
| Secondary | Brief Pain Inventory-Short Form Questionnaire | Monthly until end of treatment (18 months) | Brief Pain Inventory-Short Form (BPI-SF) Questionnaire will be collected from patients.In particular, a 0-10 numerical rating scale was used to measure pain severity items where 0=no pain and 10=pain as bad as you can imagine or with 0=pain did not interfere with my normal life and 10=pain interferes ompletely. A question about the percentage and duration of pain relief was also included. |
| Secondary | Weight evaluation | Screening visit; 18 months of treatment | Evaluation of patient weight expressed in kg after 18 months of treatment compared to baseline |
| Secondary | C-terminal telopeptide analysis | Screening visit; 2, 4, 6, 9, 12, 18 months of treatment | C-terminal telopeptide analysis (CTX, ng/ml) evaluation on peripheral blood samples |
| Secondary | Bone alkaline phosphatase analysis | Screening visit; 2, 4, 6, 9, 12, 18 months of treatment | Bone alkaline phosphatase analysis (U/uL) evaluation on peripheral blood samples |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers14
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03336983
GET https://conductscience.org/api/trials/v1/NCT03336983/registered