DAPROCA Pelvic Lymph Node Irradiation to Prostate for High Risk Prostate Cancer: Phase I/II Study (Propel)

University of Aarhus

Status: Completed

Conditions: Prostate Cancer

Treatments: Radiation: Radiation: pelvic lymph nodes with boost to prostate

Study type: Interventional

Funder types: Other

Identifiers

NCT01417676

CIRRO IP080210

Details and patient eligibility

About

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.

Enrollment: 87 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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87 participants in 1 patient group

Radiation

Experimental group

Treatment:

Radiation: Radiation: pelvic lymph nodes with boost to prostate