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Pelvic Lymph Node Irradiation With Simultaneous Integrated Boost to Prostate for High Risk Prostate Cancer Patients: A Phase I/II Study


Phase 1/Phase 2
18 Years
75 Years
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Pelvic Lymph Node Irradiation With Simultaneous Integrated Boost to Prostate for High Risk Prostate Cancer Patients: A Phase I/II Study


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of late gastro-intestinal toxicity ≥ grade 2.

Outcome Description:

based on CTCAE v.4.0 og in-house questionnaire.

Outcome Time Frame:

3 years and beyond

Safety Issue:

Yes

Principal Investigator

Lise N Bentzen, MD., Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Aarhus University Hospital, Daproca, CIRRO

Authority:

Denmark: Ethics Committee

Study ID:

CIRRO IP080210

NCT ID:

NCT01417676

Start Date:

April 2011

Completion Date:

December 2021

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • locally advanced
  • lymph node positive
  • radiation therapy
  • morbidity
  • early morbidity
  • late morbidity
  • Prostatic Neoplasms

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