Radiotherapy for Prostate Cancer: Conventional Dose Versus High Dose

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00692107
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : June 6, 2008
Erasmus Medical Center
Dutch Cancer Society
Information provided by:
The Netherlands Cancer Institute

Brief Summary:
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 or disease Intervention/treatment Phase
Prostatic Neoplasms Radiation: Gray Phase 3

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.


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 669 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 1997
Actual Primary Completion Date : May 2005
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
68 Gy
Radiation: Gray
68 Gy vs. 78 Gy
Experimental: 2
78 Gy
Radiation: Gray
68 Gy vs. 78 Gy

Primary Outcome Measures :
  1. Freedom from failure

Secondary Outcome Measures :
  1. Toxicity
  2. Overall survival
  3. Freedom from clinical failure

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00692107

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
Principal Investigator: Joos V Lebesque, MD, PhD The Netherlands Cancer Institute

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. J. Lebesque, Dr. P. Koper, Erasmus Medical Center / The Netherlands Cancer Institute Identifier: NCT00692107     History of Changes
Other Study ID Numbers: CKVO 96-10
First Posted: June 6, 2008    Key Record Dates
Last Update Posted: June 6, 2008
Last Verified: June 2008

Keywords provided by The Netherlands Cancer Institute:

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