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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01417676
Acronym
Propel
Enrollment
87
Registered
2011-08-16
Start date
2011-04-30
Completion date
2019-05-31
Last updated
2020-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

prostate cancer, locally advanced, lymph node positive, radiation therapy, morbidity, early morbidity, late morbidity

Brief summary

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.

Interventions

RADIATIONRadiation: pelvic lymph nodes with boost to prostate

78(74)Gy/39(37) fractions to prostate, 56(55)GY /39(37) fractions to pelvic lymph nodes, 5 fractions per week.

Sponsors

Rigshospitalet, Denmark
CollaboratorOTHER
Herlev Hospital
CollaboratorOTHER
Odense University Hospital
CollaboratorOTHER
Vejle Hospital
CollaboratorOTHER
Aalborg University Hospital
CollaboratorOTHER
Danish Center for Interventional Research in Radiation Oncology (CIRRO)
CollaboratorOTHER
University of Aarhus
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Patients are allocated for lymph node irradiation, either up front combined with prostate irradiation or lymph node irradiation after primary lymph adenectomy after combined with prostate irradiation.

Eligibility

Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of late gastro-intestinal toxicity ≥ grade 2.3 years and beyondbased on CTCAE v.4.0 og in-house questionnaire.

Secondary

MeasureTime frameDescription
survival10 years—
recurrence10 years—
Incidence of late genito-urinary toxicity ≥ grade 2.3 years and beyondBased on CTCAE vers. 4.0 and in-house questionnaire

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026