Clinical trial · Interventional
DAPROCA Pelvic Lymph Node Irradiation to Prostate for High Risk Prostate Cancer: Phase I/II Study
Pelvic Lymph Node Irradiation With Simultaneous Integrated Boost to Prostate for High Risk Prostate Cancer Patients: A Phase I/II Study
NCT01417676CI-TRIAL-00045755PropelcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a prospective, open label 1 arm study, multicentre, Phase I/II clinical safety study. The trial is designed to gain initial safety and efficacy data on pelvic lymph node radiation with simultaneous integrated boost to prostate in high risk prostate cancer patients.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation: pelvic lymph nodes with boost to prostate | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiation
- interventionNames
- Radiation: Radiation: pelvic lymph nodes with boost to prostate
Primary outcomes (1)
- measure
- Incidence of late gastro-intestinal toxicity ≥ grade 2.
- timeFrame
- 3 years and beyond
- description
- based on CTCAE v.4.0 og in-house questionnaire.
Secondary outcomes (3)
- measure
- survival
- timeFrame
- 10 years
- measure
- recurrence
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * adenocarcinoma * T3 tumor and either Gleason 8-10 and PSA ≤ 70,or PSA ≥ 30 and PSA ≤ 70, or T1-T3 and PSA ≤ 70 and N1 * no distant metastases Exclusion Criteria: * pelvic co-morbidity such as Crohns disease or ulcerative colitis * uncontrolled heart or lung morbidity * prior radiation treatment of pelvic region * age \> 75 years
References
Publications (0)
Data not yet available
No reference posted for this study.