AzTrials
AzTrials

Prostate CancerPhase 2/32FNCT06601205

Finasteride and Flutamide in Pre-surgical Trial in Prostate Cancer.

A Phase 2/3 study testing Flutamide and Finasteride in people with Prostate Cancer and Prostatic Intraepithelial Neoplasia, run by Ente Ospedaliero Ospedali Galliera at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Pre-surgical, window-of-opportunity trials provide a suitable model to assess the activity of preventive interventions in a cost-effective manner using tissue biomarkers as surrogate endpoints. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Flutamide and Finasteride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
125 participants
Where
1 siteItaly
Study dates
1 Jan 2004to 16 Jun 2017
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged > 18 years
  • Patients with a biopsy proven, clinically intracapsular PCa who are candidates to radical retropubic prostatectomy
  • ECOG performance status ≤ 2
  • Satisfactory hematological and biochemical functions:
  • Platelets ≥100 x 10^9/L
  • AST and ALT in the normal range
  • Able to understand and sign an informed consent

Who cannot join

  • Previous hormone treatment during the 8 weeks before enrollment
  • Neurologic and psychiatric diseases precluding patient participation in the study
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing or participating in the study and/or comply with the study procedures.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Medical Oncology Ente Ospedaliero Ospedali Galliera

    Genova, Italy, 16128

Other trials in Italy

About this study

Official title: A Randomized, Phase IIB, Double Blind, Placebo Controlled, Multicenter, Pre-surgical, Window-of-opportunity Trial of Finasteride Vs. Low-dose Flutamide Vs. Placebo in Prostate Cancer (2F Trial)

Pre-surgical, window-of-opportunity trials provide a suitable model to assess the activity of preventive interventions in a cost-effective manner using tissue biomarkers as surrogate endpoints. Finasteride has been shown to reduce prostate cancer development in a large phase III trial, and flutamide has a well-known anticancer effect in advanced prostate cancer at the dose of 750 mg/day.

Read the detailed description

In this randomized, phase IIB, double blind, placebo controlled, multicenter, pre-surgical, window-of-opportunity trial we compared the effects of finasteride (5 mg/day) versus low-dose flutamide (250 mg/day) or placebo on tissue biomarkers in patients with prostate cancer who were candidate to radical surgery. Specifically, the effects of both drugs on the change in epithelial cell nuclear area in prostate cancer tissue between pre- and post-treatment biopsies was evaluated (primary endpoint). Moreover, the changes of the proliferation marker Ki-67 and of karyometric parameters in benign, dysplastic (HG-PIN) and malignant tissues were evaluated (secondary endpoints). Additional endpoints include the changes of serum PSA and testosterone, assessment of toxicity, overall survival, recurrence-free survival and event-free (recurrence + death) survival. Patients with intracapsular biopsy proven prostate cancer were randomized to either flutamide, 250 mg/day, or finasteride, 5 mg/day, or placebo for 4-6 weeks before radical prostatectomy. Blood samples were taken before and after treatment. At surgery, end-of-study ex-vivo biopsies were obtained from the prostatectomy specimens to assess the treatment changes in nuclear area (primary endpoint), Ki-67, topoisomerase-II-α and a 20-feature karyometric discrimant function in normal, high-grade PIN and malignant tissue. After surgery patients were followed up for at least 15 years to assess recurrence and/or mortality. We also plan to follow-up patients by telephone interview to assess their vital status for up to 20 years.

Being tested
Flutamide, Finasteride, Placebo
Keywords
Prostate Cancer, Prostatic Intraepithelial Neoplasia, Chemoprevention, Flutamide, Finasteride, Biomarkers, drug response, Karyometry
Medical subject headings
Prostatic Neoplasms, Prostatic Intraepithelial Neoplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FlutamideDrug

    Also called Arm A

    1 tablet daily until the day before surgery

  • FinasterideDrug

    Also called Arm B

    1 tablet daily until the day before surgery

  • PlaceboOther

    Also called Arm C

    1 tablet daily until the day before surgery

Study groups in NCT06601205
Study groupRoleWhat they receive
FlutamideExperimental1 tablet 250 mg daily until the day before surgery
Receives: Drug: Flutamide
FinasterideExperimental1 tablet 5 mg daily until the day before surgery
Receives: Drug: Finasteride
PlaceboPlacebo comparator1 tablet daily until the day before surgery
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of Nuclear area size

    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.

    Measured: 4-6 weeks (baseline and at the end of the study biopsy)

Secondary outcomes (7)

  1. Change of ki-67 value

    Changes of Ki-67 labeling index in normal, HG-PIN and prostate cancer cells in the three arms.

    Measured: 4-6 weeks (baseline and at the end of the study biopsy)

  2. Change Kariometry value

    Changes in karyometric features in normal HG-PIN and prostate cancer cells in the three arms.

    Measured: 4-6 weeks (baseline and at the end of the study biopsy)

  3. Serum biomarkers values

    Changes in total PSA, free PSA and testosterone concentrations after treatment in the three arms.

    Measured: 4-6 weeks (on blood samples at baseline and the day before surgery)

  4. Adverse Events

    Toxicity is assessed using the National Cancer Institute-Common Terminology Criteria for Adverse Events (version 3, 2003).

    Measured: 4-6 weeks (during the treatment)

  5. Recurrence-free survival

    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.

    Measured: up to 20 years

  6. Comparison of Event free survival

    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.

    Measured: up to 20 years

  7. Comparison of Overall Survival

    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.

    Measured: up to 20 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start1 Jan 2004
  3. Primary completion20 Mar 2008
  4. Study completion16 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study was a prospective, randomized, phase IIB, placebo controlled, double-blind, pre-surgical trial of Finasteride 5 mg day versus Flutamide 250 mg day versus placebo in men with PCa. Patients with a biopsy proven, clinically intracapsular prostate cancer who were candidate to radical retropubic prostatectomy were enrolled in four different institutions in Northern Italy. Different biopsy criteria according to each contributing centre were acceptable provided that a minimum of 8 cores were evaluable. Patients were randomized to receive either flutamide, 250 mg/day orally, or finasteride, 5 mg/day orally, or oral placebo in a double-blind manner beginning 4 to 6 weeks before surgery.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06601205
Sponsor's protocol ID
13CE20102003
Other IDs
Italian League against Cancer, Berlucchi Foundation
Acronym
2F
Status last verified
Feb 2019
First submitted
12 Feb 2019
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Flutamide and Finasteride in people with Prostate Cancer and Prostatic Intraepithelial Neoplasia, run by Ente Ospedaliero Ospedali Galliera at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Nuclear area size (time frame: 4-6 weeks (baseline and at the end of the study biopsy)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06601205.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in