Trial · NCT07237269
Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer
NCT07237269, Phase 2, Recruiting, University of Nebraska
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer. Trials, record NCT07237269. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07237269
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer
- NCT number
- NCT07237269
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 140 participants, estimated
- Lead sponsor
- University of Nebraska
- Conditions
- Prostate Cancer
- Interventions
- Androgen Deprivation Therapy (ADT), Abiraterone, Prednisone, Radiation Therapy
- First posted
- 2025-11-19
- Last updated
- 2026-10-19
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 5-year failure-free survival rate | From randomization up to 5 years | Determine the impact of enhanced ADT with abiraterone/prednisone versus standard ADT on the 5-year failure-free survival of patients with PSMA-positive conventionally negative pelvic lymphadenopathy (i.e. \<1cm in smallest diameter). |
| Secondary | Toxicity in both arms from 3 months to 2 years post-ADT. | From 3 months to 2 years post-ADT | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 |
| Secondary | Evaluate and compare patient-reported symptom outcomes in both arms from 3 months to 2 years post-ADT. (IPSS) | From 3 months to 2 Years post-ADT | Using IPSS (International Prostate Symptom Score). The quality-of-life measures will be summarized using descriptive statistics at each time point collected as n, mean, SD, median, minimum, and maximum. The IPSS score ranges from 0 to 35, with higher scores indicating worse urinary symptoms. |
| Secondary | Evaluate and compare patient-reported symptom outcomes in both arms from 3 months to 2 years post-ADT. (FACT-P) | From 3 months to 2 Years post-ADT | Using FACT-P (Functional Assessment of Cancer Therapy-Prostate.) The quality of life measures will be summarized using descriptive statistics at each time point collected as n, mean, SD, median, minimum, and maximum. The FACT-P score ranges from0 to 156, with higher scores indicating better quality of life. |
| Secondary | Evaluate local progression-free survival (i.e., failure-free survival excluding biochemical failure). | From randomization up to 5 years | Evaluate progression-free survival (i.e., failure-free survival excluding biochemical failure). Progression-free survival will be estimated with the Kaplan-Meier method and will be compared between treatment arms with the log-rank test. The 5-year survival rates will be estimated with a 95% confidence interval. Time to local failure is defined as time since randomization to disease progression within the intact prostate. Regional, metastases, and deaths are treated as competing events. |
| Secondary | Evaluate locoregional progression-free survival (i.e., failure-free survival excluding biochemical failure). | From randomization up to 5 years | Evaluate progression-free survival (i.e., failure-free survival excluding biochemical failure). Progression-free survival will be estimated with the Kaplan-Meier method and will be compared between treatment arms with the log-rank test. The 5-year survival rates will be estimated with a 95% confidence interval. Time to locoregional failure is defined as time since randomization to disease progression within the pelvis and pelvic lymph nodes. Metastases and deaths are treated as competing events. |
| Secondary | Evaluate 5-year overall survival | From randomization up to 5 years | Overall survival will be estimated with the Kaplan-Meier method and will be compared between treatment arms with the log-rank test. The 5-year survival rates will be estimated with a 95% confidence interval. Overall survival is defined as the time since the date of randomization to the date of death or last follow-up. |
| Secondary | Evaluate 5-year cancer-specific survival | From randomization up to 5 years | Cumulative incidence methods will be used to estimate 5-year rates (with 95% CI) of LC, LRC, and DM while accounting for death as a competing event. Cancer-specific survival is defined as time since the date of randomization to the date of death due to cancer diagnosis or treatment or last follow-up. Deaths due to other causes are treated as competing events. |
| Secondary | Evaluate 5-year metastasis-free survival. | From randomization up to 5 years | Time to distant metastasis is defined as time since date of randomization to distant metastases in para-aortic lymph nodes and distant organs or last follow-up. Locoregional failures and deaths are treated as competing events. |
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/NCT07237269
GET https://conductscience.org/api/trials/v1/NCT07237269/registered