Clinical trial · Interventional
Neoadjuvant J591 Treatment for Prostate Cancer
A Pilot Study of Neoadjuvant Monoclonal Antibody Humanised (hu) J591 for the Treatment of High and/or Intermediate-Risk Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
10 patients will be enrolled in the initial cohort and will receive two infusions of unlabeled huJ591 on days 1 and 14. 89Zr-J591 will be administered on day 21 (+ 1 day) and a positron emission tomography-computed tomography (PET/CT) will be performed week later on day 28 + 1 (visit 4). Approximately 2 to 3 weeks after the 2nd dose of J591, the patient will undergo radical prostatectomy with or without lymph node dissection (day 31 + 4 days). The final visit for the study will include a postoperative visit two weeks following surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 89Zr-J591 | Drug | — | UNRESOLVED |
| huJ591 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- huJ591 followed by 89Zr-J591
- description
- Subjects will receive two infusions of unlabeled huJ591 on days 1 and 15 (+/- 1 day). 89Zr-J591 will be administered on day 22 (+/- 1 day) and 5-8 days later. PET/CT will be performed followed by repeat imaging of the prostate. Radical prostatectomy with or without lymph node dissection is performed 2 to 4 weeks after the second dose of J591.
- interventionNames
- Drug: huJ591
- Drug: 89Zr-J591
Primary outcomes (1)
- measure
- Induction of inflammatory and/or apoptotic response of prostate cancer cells by reviewing H&E stained slides from pre treatment biopsy and comparing to the post-treatment radical prostatectomy pathology using the Peri-tumoral inflammation 4-point scoring
- timeFrame
- Change from baseline in Peri-tumoral inflammation 4-point scoring at Day 31 post prostatectomy
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
1. Adult male \> 18 years of age
2. Histologically confirmed diagnosis of prostate cancer
3. Intermediate or high risk prostate cancer defined by:
* High risk (any one of the following):
1. Gleason grade \> 8
2. Gleason grade 4+3 with more than 3 cores involved with \> 20% of volume involved
3. Any Gleason with PSA above 20 ng/mL
4. Gleasone \> 4+3 and tumor stage clinical T3 or above
* Intermediate risk prostate cancer defined as:
1. Gleason grade = 7
2. Any Gleason with PSA between 10 and 20 ng/mL
4. Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1
5. Ability to understand and willingness to sign a written informed consent document
6. Prostate biopsy with + PSMA expression in tumor cells by immunohistochemistry
Exclusion Criteria:
1. Serum creatinine \> 3x upper limit of normal (ULN)
2. Bilirubin (total) \> 1.5 x ULN; subjects with Gilbert's syndrome will be allowed if direct bilirubin is within institutional normal limits
3. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT or SGOT) \> 2.5x ULN
4. Other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with study participation
5. On any other new anticancer therapy between screening and prostatectomy
6. Frank metastasis identified during clinical staging
7. Patient ineligible for radical prostatectomy for any other reasonReferences
Publications (0)
Data not yet available