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NCT07237269
Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer
Phase 2 trial testing Androgen Deprivation Therapy (ADT) in Prostate Cancer in 140 participants. Currently enrolling.
3 April 2033
Quick facts
| Lead sponsor | University of Nebraska |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 140 |
| Start date | 3 April 2026 |
| Primary completion | 3 April 2033 |
| Estimated completion | 3 April 2033 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Androgen Deprivation Therapy (ADT) — full drug profile →
- Abiraterone (ABIRATERONE) — full drug profile →
- Prednisone (prednisone) — full drug profile →
- Radiation Therapy
Conditions studied
- Prostate Cancer — all drugs for Prostate Cancer →
Sponsor
University of Nebraska
Who can join
30 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The advent of PSMA-PET has improved sensitivity and specificity in staging prostate cancer, particularly in intermediate- and high-risk disease. This has created uncertainty in the management of patients with PSMA-positive but conventionally negative pelvic lymphadenopathy (i.e., \<1 cm in smallest diameter). This study evaluates outcomes of enhanced androgen deprivation therapy (ADT) with abiraterone and prednisone compared to standard ADT, both in combination with radiation therapy, in patients with prostate cancer and PSMA-positive but conventionally negative pelvic lymphadenopathy. A total of 140 eligible participants will be randomized to receive either enhanced ADT with abiraterone and prednisone or standard ADT, both with concurrent radiation therapy. Participants will be followed for 5 years after completion of ADT to assess outcomes. The primary objective is to determine whether enhanced ADT improves 5-year failure-free survival compared to standard ADT. Secondary objectives include evaluation of toxicity, quality of life, biochemical progression-free survival, cancer-specific survival, overall survival, and metastasis-free survival. Exploratory objectives include evaluation of tumor growth and regression rates using PSA values and assessment of the relationship between treatment outcomes and blood-based heme oxygenase-1 (HO-1) levels.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07237269
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Related trials
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Trials testing the same drug.
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- NCT07313241 — Phase II Trial of PSA Response-based Androgen Deprivation Therapy and Nodal Coverage for Prostate Cancer Early Salvage R · Phase 2 · recruiting
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Other recruiting trials for Prostate Cancer
Currently open trials in the same condition.
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- NCT07426094 — PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate · Phase 2, PHASE3 · recruiting
- NCT07145177 — 177Lu-PSMA-617 With Liver Directed Therapy in Metastatic Castration Resistant Prostate Cancer · Phase 1 · recruiting
Other University of Nebraska trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07237269 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Nebraska
- Last refreshed: 15 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07237269.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing