Trial · NCT06601205
Finasteride and Flutamide in Pre-surgical Trial in Prostate Cancer.
NCT06601205, Phase 2, Phase 3, Completed, Ente Ospedaliero Ospedali Galliera
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Finasteride and Flutamide in Pre-surgical Trial in Prostate Cancer. Trials, record NCT06601205. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06601205
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Finasteride and Flutamide in Pre-surgical Trial in Prostate Cancer.
- NCT number
- NCT06601205
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 125 participants, actual
- Lead sponsor
- Ente Ospedaliero Ospedali Galliera
- Conditions
- Prostate Cancer, Prostatic Intraepithelial Neoplasia
- Interventions
- Flutamide, Finasteride, Placebo
- First posted
- 2024-09-19
- Last updated
- 2024-09-19
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change of Nuclear area size | 4-6 weeks (baseline and at the end of the study biopsy) | The study primary endpoint is the change of epithelial cell nuclear area in prostate cancer tissue and HG-PIN tissue between pre- and post-treatment measure in the two active treatment arms (Finasteride or Flutamide) compared with the placebo arm. |
| Secondary | Change of ki-67 value | 4-6 weeks (baseline and at the end of the study biopsy) | Changes of Ki-67 labeling index in normal, HG-PIN and prostate cancer cells in the three arms. |
| Secondary | Change Kariometry value | 4-6 weeks (baseline and at the end of the study biopsy) | Changes in karyometric features in normal HG-PIN and prostate cancer cells in the three arms. |
| Secondary | Serum biomarkers values | 4-6 weeks (on blood samples at baseline and the day before surgery) | Changes in total PSA, free PSA and testosterone concentrations after treatment in the three arms. |
| Secondary | Adverse Events | 4-6 weeks (during the treatment) | Toxicity is assessed using the National Cancer Institute-Common Terminology Criteria for Adverse Events (version 3, 2003). |
| Secondary | Recurrence-free survival | up to 20 years | Comparison of Recurrence-free survival among arms will be assessed by the Kaplan Meier actuarial survival curves and analyzed by the log-rank test and the Cox proportional hazard model for multivariate analyses. Vital status and medical condition will be assessed by telephone interview and clinical visit. |
| Secondary | Comparison of Event free survival | up to 20 years | Comparison of Event free survival among arms will be assessed by the Kaplan Meier actuarial survival curves and analyzed by the log-rank test and the Cox proportional hazard model for multivariate analyses. Vital status and medical condition will be assessed by telephone interview and clinical visit. |
| Secondary | Comparison of Overall Survival | up to 20 years | Comparison of Overall Survival among arms will be assessed by the Kaplan Meier actuarial survival curves and analyzed by the log-rank test and the Cox proportional hazard model for multivariate analyses. Vital status and medical condition will be assessed by telephone interview and clinical visit. |
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT06601205
GET https://conductscience.org/api/trials/v1/NCT06601205/registered