Trial · NCT07455903
Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT
NCT07455903, Phase 2, Recruiting, Baptist Health South Florida
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT. Trials, record NCT07455903. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07455903
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT
- NCT number
- NCT07455903
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 50 participants, estimated
- Lead sponsor
- Baptist Health South Florida
- Conditions
- Prostate Cancer, Localized Prostate Carcinoma
- Interventions
- Leuprolide, Degarelix, Relugolix, Triptorelin, Bicalutamide, 18-F Flotufolastat PSMA PET, Radical prostatectomy
- First posted
- 2026-03-06
- Last updated
- 2026-08-06
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective response rate (ORR) based on PSMA PET | 6 Months | ORR is based on changes in maximum standard uptake value (SUVmax) on PSMA PET/CT imaging pre- and post-ADT. Complete response (CR) is defined as resolution of all PSMA-avid lesions. Partial response (PR) is defined as \>30% decrease in SUVmax. Progressive disease (PD) is defined as \>30% increase in SUVmax or presence of new PSMA-avid lesions. Stable disease (SD) is defined as not meeting criteria for CR, PR, or PD. ORR is defined as the proportion of participants having CR or PR after ADT based on SUVmax. |
| Primary | ORR based on Response Evaluation Criteria in PSMA Imaging (RECIP 1.0) | 6 Months | ORR in this endpoint is based on RECIP 1.0 criteria. Complete response (CR) is defined as disappearance of all PSMA-avid disease. Partial response (PR) is defined as ≥30% increase in total tumor volume. Progressive disease (PD) is defined as ≥20% increase in total tumor volume or presence of new PSMA-avid lesions. Stable disease (SD) is defined as not meeting criteria for CR, PR, or PD. ORR is defined as the proportion of participants having CR or PR after ADT based on RECIP 1.0. |
| Secondary | Prostate-Specific Antigen (PSA) response rate | 36 Months | Defined as the proportion of participants with a PSA reduction of at least 50% (PSA50) immediately prior to RP compared with baseline PSA after treatment with ADT. |
| Secondary | Biochemical recurrence-free survival (BCR) with testosterone recovery | 36 months | BCR with testosterone recovery is defined as the time from ADT initiation to PSA ≥0.2 ng/mL after RP once testosterone has normalized. Median times will be calculated for responders (CR and PR) and non-responders (SD and PD). |
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/NCT07455903
GET https://conductscience.org/api/trials/v1/NCT07455903/registered