Radiotherapy for Prostate Cancer: Conventional Dose Versus High Dose

This study has been completed.
Sponsor:
Collaborators:
Erasmus Medical Center
Dutch Cancer Society
Information provided by:
The Netherlands Cancer Institute
ClinicalTrials.gov Identifier:
NCT00692107
First received: August 25, 2005
Last updated: June 5, 2008
Last verified: June 2008
  Purpose

3-D conformal radiotherapy offers the opportunity to reach higher tumor doses with acceptable complication rates compared to conventional radiotherapy. There are retrospective and preliminary prospective reports of a better local control / disease free survival (including PSA control) using higher tumor doses. A prospective randomised phase III study is required to validate these reports. The purpose of this randomized phase III study is to investigate and compare the tumor control and toxicity in prostate cancer patients treated to 68 Gy and 78 Gy;


Condition Intervention Phase
Prostatic Neoplasms
Radiation: Gray
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Study for Prostate Cancer, Randomizing Between Two Radiation Dose Levels (68 Gy vs. 78 Gy) and Utilizing Three Dimensional Conformal Radiotherapy

Resource links provided by NLM:


Further study details as provided by The Netherlands Cancer Institute:

Primary Outcome Measures:
  • Freedom from failure

Secondary Outcome Measures:
  • Toxicity
  • Overall survival
  • Freedom from clinical failure

Enrollment: 669
Study Start Date: June 1997
Study Completion Date: December 2007
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
68 Gy
Radiation: Gray
68 Gy vs. 78 Gy
Experimental: 2
78 Gy
Radiation: Gray
68 Gy vs. 78 Gy

Detailed Description:

Patients were stratified by hospital, treatment group, age and (neo)adjuvant hormonal therapy. Four treatment groups with specific radiation volumes were defined depending on the estimated risk of tumour involvement of the seminal vesicles (based on T-stage, initial PSA and Gleason Score or Differentiation Grade).The dose was delivered with daily fractions of 2 Gy, five times a week. The total duration of the treatment was 7 weeks for patients treated to 68 Gy and 8 week for 78 Gy.

Objectives:

  • To test in a phase III randomised study the hypothesis that higher radiation doses lead to a higher freedom from failure rate for localized prostate cancer.
  • To test the hypothesis that a higher freedom from failure rate leads to a longer disease-free survival and overall survival.
  • To limit acute and late toxicity with respect to gastro-intestinal and urological toxicity.
  • To evaluate different PSA related endpoints for local failure and distant metastasis.
  • To establish a database of patients treated to escalated doses with Dose Volume Histograms of the normal tissues at risk for each individual patient and common toxicity endpoints.
  • To validate a model to estimate normal tissue complication probabilities (NTCPs) of rectum and bladder, based on the above-mentioned database, and to obtain reliable parameter values for NTCP estimations.
  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • locally confined adenocarcinoma of the prostate
  • all T-stages with a PSA < 60ng/ml, except any T1a tumor and well-differentiated (or Gleason score < 5) T1b-c tumors with PSA-levels ≤ 4 ng/ml
  • Karnofsky Performance Status of 80 or more

Exclusion Criteria:

  • distant metastases
  • positive regional lymph nodes proven by surgical or cytological sampling
  • on anticoagulants
  • previous prostatectomy
  • previous pelvic irradiation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00692107

Locations
Netherlands
The Netherlands Cancer Institute
Amsterdam, Netherlands, 1066CX
Radiotherapeutic Institute Friesland
Leeuwarden, Netherlands, 8934 AD
Daniel Den Hoed Cancer Center
Rotterdam, Netherlands, 3075 EA
Zeeuws Radiotherapeutic Institute
Vlissingen, Netherlands, 4382 EE
Sponsors and Collaborators
The Netherlands Cancer Institute
Erasmus Medical Center
Dutch Cancer Society
Investigators
Principal Investigator: Joos V Lebesque, MD, PhD The Netherlands Cancer Institute
  More Information

Publications:
Responsible Party: Dr. J. Lebesque, Dr. P. Koper, Erasmus Medical Center / The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT00692107     History of Changes
Other Study ID Numbers: CKVO 96-10
Study First Received: August 25, 2005
Last Updated: June 5, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by The Netherlands Cancer Institute:
Radiotherapy
Dose

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 15, 2014