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Trial · NCT06795178

Efficacy, Safety, and Pharmacokinetics of FP-014, 11.25 mg in Patients With Advanced Prostate Cancer

NCT06795178, Phase 3, Withdrawn, Foresee Pharmaceuticals Co., Ltd.

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Efficacy, Safety, and Pharmacokinetics of FP-014, 11.25 mg in Patients With Advanced Prostate Cancer. Trials, record NCT06795178. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06795178

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Efficacy, Safety, and Pharmacokinetics of FP-014, 11.25 mg in Patients With Advanced Prostate Cancer
NCT number
NCT06795178
Status
Withdrawn
Phases
Phase 3
Enrollment
0 participants, actual
Lead sponsor
Foresee Pharmaceuticals Co., Ltd.
Conditions
Prostate Cancer
Interventions
FP-014
First posted
2025-01-27
Last updated
2025-04-27

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPrimary EndpointsWeek 4 (Day 28 ± 1 day) through Week 24 (Day 168 ± 5 days).
The percentage of patients with a serum testosterone concentration suppressed to castrate levels (\< 50 ng/dL) by Week 4 (Day 28 ± 1 day) following the first SC injection of FP-014 (11.25 mg). The percentage of patients with serum testosterone concentration suppressed to castrate levels (\< 50 ng/dL)
SecondarySecondary EndpointsWeek 24/End of Study (EOS) (Day 168 ± 5 days).
The mean acute-on-chronic (surge) changes in serum testosterone and LH levels prior to the second injection through 48-72 hours after the second injection of FP-014, 11.25 mg. The mean change of serum LH levels
SecondarySecondary EndpointsBaseline to Week 24/EOS (Day 168 ± 5 days).The mean change of serum PSA levels
SecondarySecondary EndpointsWeek 24/EOS (Day 168 ± 5 days)/Week 24/EOS (Day 168 ± 5 days).
The percentage of patients with: . PSA relapse (defined as an increase in serum PSA of \> 50% PSA nadir by Week 24/EOS (Day 168 ± 5 days) after achieving serum PSA level ≤ 4 ng/mL post administration of FP-014, 11.25 mg. Within normal limit serum PSA level (≤ 4 ng/mL) by Week 24/EOS (Day 168 ± 5 days).
SecondarySecondary EndpointsWeek 4 (Day 28 ± 1 day) and at Week 24/EOS (Day 168 ± 5 days)The percentage of patients with enhanced serum testosterone concentration suppression to \< 20 ng/dL
SecondarySecondary EndpointsBaseline to Week 24/EOS (Day 168 ± 5 days).Urinary signs and symptoms, i.e. a patient-reported outcome (PRO) assessed by the total score of the International Prostate Symptom Score (I-PSS) sheet (Range 0-35 with 35 being the worst symptoms)

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT06795178

GET https://conductscience.org/api/trials/v1/NCT06795178/registered