Relugolix in Patients With High-risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy.
NCT07927777, Phase 3, Not yet recruiting, Istituto Oncologico Veneto IRCCS
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Relugolix in Patients With High-risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy. | ClinicalTrials.gov |
| NCT number | NCT07927777 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 3 | ClinicalTrials.gov |
| Enrollment | 268 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Istituto Oncologico Veneto IRCCS | ClinicalTrials.gov |
| Conditions | Locally Advanced Prostate Cancer | ClinicalTrials.gov |
| Interventions | Relugolix-Neoadjuvant treatment, Relugolix-Adjuvant treatment | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Biochemical Recurrence-Free Survival (bRFS) | Through study completion, an average of 3 years | Biochemical Recurrence-Free Survival (bRFS) defined as the time from randomization to the first documented evidence of biochemical recurrence, measured as: * A confirmed serum PSA value ≥ 0.2 ng/mL after radical prostatectomy (two consecutive determinations at least 3 weeks apart), or * The clinical decision to initiate salvage therapy (radiotherapy or systemic therapy) for a documented biochemical recurrence (any non-protocol defined treatment) * Any new evidence of metastatic disease on bone or PSMA PET/mpMRI \[imaging modalities as per physician or multidisciplinary team decision's discretion\] * Any local recurrence in the prostate bed, as determined by PSMA PET/ mpMRI; \[imaging modalities as per physician or multidisciplinary team decision's discretion\]. Patients without an event will be censored at the date of their last PSA assessment. | ClinicalTrials.gov |
| Secondary | Metastasis-Free Survival (MFS) | Through study completion, an average of 3 years | MFS will be defined as the time from randomization to the first radiological evidence of distant metastasis (confirmed by blinded independent central review, BICR) or death from any cause. | ClinicalTrials.gov |
| Secondary | Pathological Complete Response (pCR) | Through study completion, an average of 3 years | pCR will be defined as no residual tumor ypT0 detected in the prostatectomy specimen, as assessed by a pathology BICR); | ClinicalTrials.gov |
| Secondary | Minimal Residual Disease (MRD) | Through study completion, an average of 3 years | MRD will be defined as presence of residual tumor ≤ 5 mm in maximal cross-sectional dimension provided it is confined to the prostate, i.e. ypT2 or lower. The primary pathology assessment will be performed by a blinded independent central review (BICR). | ClinicalTrials.gov |
| Secondary | Overall Survival (OS) | Through study completion, an average of 3 years | Overall Survival (OS) will be defined as time from randomization to death from any cause | ClinicalTrials.gov |
| Secondary | Time to Castration-Resistant Prostate Cancer (CRPC) | Through study completion, an average of 3 years | Time to Castration-Resistant Prostate Cancer (CRPC) will be evaluated as time from randomization to evidence of disease progression at CRPC | ClinicalTrials.gov |
| Secondary | Time to First Salvage Therapy (Radiotherapy or systemic) | Through study completion, an average of 3 years | Time to First Salvage Therapy will be evaluated as time from randomization to the start date of the first systemic therapy or radiotherapy (RT) | ClinicalTrials.gov |
| Secondary | Testosterone suppression and recovery | Through study completion, an average of 3 years | Testosterone suppression and recovery will be defined as: o Proportion of patients achieving testosterone ≤ 50 ng/dL and ≤ 20 ng/dL during treatment. | ClinicalTrials.gov |
| Secondary | Testosterone suppression and recovery | Through study completion, an average of 3 years | Testosterone suppression and recovery will be defined as: o Time to testosterone recovery (≥ 280 ng/dL) after treatment discontinuation. | ClinicalTrials.gov |
| Secondary | PSA kinetics | Through study completion, an average of 3 years | PSA kinetics will be evaluated as proportion of patients achieving ≥ 90% PSA reduction from baseline, and PSA \< 0.2 ng/mL at Week 25. | ClinicalTrials.gov |
| Secondary | Quality of Life (QoL) | Through study completion, an average of 3 years | Quality of Life (QoL) will be assessed by EORTC-QLQ-C30 domain scores at ICF signing, at the end of perioperative period (for Arm A), at 15 days from RP; 4 weeks post-RP; 12 weeks post-RP; End Of Treatment; 12 weeks post-EOT; 6 months post-EOT; 12 months post-EOT | ClinicalTrials.gov |
| Secondary | Quality of Life (QoL) | Through study completion, an average of 3 years | Quality of Life (QoL) will be assessed by EORTC-QLQ-PR25 domain scores at ICF signing, at the end of perioperative period (for Arm A), at 15 days from RP; 4 weeks post-RP; 12 weeks post-RP; End Of Treatment; 12 weeks post-EOT; 6 months post-EOT; 12 months post-EOT | ClinicalTrials.gov |
| Secondary | Safety and tolerability of Relugolix | Through study completion, an average of 3 years | Safety and tolerability during the treatment will be recorded and graded according to the NCI-Common Terminology Criteria for Adverse Events (CTCAE) v.5. Grade refers to the severity of the adverse event. A grading (severity) scale is provided for each adverse event term. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Safety and tolerability will be evaluated also as laboratory, ECG abnormalities and cardiovascular events (MACE). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)