Clinical trial · Interventional
CivaSheet With Radical Prostatectomy & Adjuvant External Beam Radiation
A Phase I Single-Arm Open Label Dose-Escalation Study of CivaSheet With Radical Prostatectomy With or Without Adjuvant External Beam Radiation Therapy in Patients With High Risk Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Decision made by DSMB to terminate study in April 2023.
Summary
Brief summary (as posted)
A phase I single-arm open label dose escalation study to evaluate the maximum tolerated dose (MTD) and safety of Civasheet® with radical prostatectomy (RP) and adjuvant external beam radiation therapy (EBRT) in a 3+3 dose escalation design among participants with high risk prostate cancer (PCa).
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuvant external beam radiation therapy | Radiation | — | UNRESOLVED |
| Civasheet 60 Gy | Radiation | — | UNRESOLVED |
| Civasheet 75 Gy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- group 1 of 60 Gy dose
- description
- The first 3 subsequent patients with high risk prostate cancer will be undergoing radical prostatectomy Interventions: Civasheet 60 Gy + Adjuvant external beam radiation therapy
- interventionNames
- Radiation: Civasheet 60 Gy
- Radiation: Adjuvant external beam radiation therapy
- type
- EXPERIMENTAL
- label
- group 2 of 60 Gy dose
- description
- The second 3 subsequent patients with high risk prostate cancer will be undergoing radical prostatectomy Interventions: Civasheet 60 Gy + Adjuvant external beam radiation therapy
- interventionNames
- Radiation: Civasheet 60 Gy
- Radiation: Adjuvant external beam radiation therapy
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Any subject with National Comprehensive Cancer Network (NCCN) very high or high risk adenocarcinoma of the prostate defined as ≥T3a, Gleason score ≥ 8, or PSA \> 20 who is eligible for RP (open or robotic) with adjuvant EBRT as an initial treatment option. * Any subject with NCCN Intermediate Risk adenocarcinoma of the prostate defined as T2b-T2c, Gleason score 7, or PSA 10-20 who is eligible for RP (open or robotic) with adjuvant EBRT as an initial treatment option and at least one of the following adverse features present in pre-operative imaging: seminal vesicle infiltration (SVI), extracapsular extension (ECE), N1 disease. * Subject must have had a pre-operative MRI or must obtain a pre-operative MRI to be eligible for participation in this study. * Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: * Any subject who has undergone prior radiation to the pelvis. * Subjects presenting with distant metastases. * On any investigational drug(s), androgen deprivation therapy or therapeutic device(s) within 30 days preceding screening. * Currently taking immunosuppressants, or with poorly controlled diabetes (HbA1c \>8).
References
Publications (0)
Data not yet available