Radiotherapy for Prostate Cancer: Conventional Dose Versus High Dose
Primary Purpose
Prostatic Neoplasms
Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Gray
Gray
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Neoplasms focused on measuring Radiotherapy, Dose
Eligibility 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
Sites / Locations
- The Netherlands Cancer Institute
- Radiotherapeutic Institute Friesland
- Daniel Den Hoed Cancer Center
- Zeeuws Radiotherapeutic Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
68 Gy
78 Gy
Outcomes
Primary Outcome Measures
Freedom from failure
Secondary Outcome Measures
Toxicity
Overall survival
Freedom from clinical failure
Full Information
NCT ID
NCT00692107
First Posted
August 25, 2005
Last Updated
June 5, 2008
Sponsor
The Netherlands Cancer Institute
Collaborators
Erasmus Medical Center, Dutch Cancer Society
1. Study Identification
Unique Protocol Identification Number
NCT00692107
Brief Title
Radiotherapy for Prostate Cancer: Conventional Dose Versus High Dose
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 Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
June 1997 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
The Netherlands Cancer Institute
Collaborators
Erasmus Medical Center, Dutch Cancer Society
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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;
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
Radiotherapy, Dose
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
669 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
68 Gy
Arm Title
2
Arm Type
Experimental
Arm Description
78 Gy
Intervention Type
Radiation
Intervention Name(s)
Gray
Intervention Description
68 Gy vs. 78 Gy
Intervention Type
Radiation
Intervention Name(s)
Gray
Intervention Description
68 Gy vs. 78 Gy
Primary Outcome Measure Information:
Title
Freedom from failure
Secondary Outcome Measure Information:
Title
Toxicity
Title
Overall survival
Title
Freedom from clinical failure
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joos V Lebesque, MD, PhD
Organizational Affiliation
The Netherlands Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Netherlands Cancer Institute
City
Amsterdam
ZIP/Postal Code
1066CX
Country
Netherlands
Facility Name
Radiotherapeutic Institute Friesland
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
Daniel Den Hoed Cancer Center
City
Rotterdam
ZIP/Postal Code
3075 EA
Country
Netherlands
Facility Name
Zeeuws Radiotherapeutic Institute
City
Vlissingen
ZIP/Postal Code
4382 EE
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
15752881
Citation
Peeters ST, Heemsbergen WD, van Putten WL, Slot A, Tabak H, Mens JW, Lebesque JV, Koper PC. Acute and late complications after radiotherapy for prostate cancer: results of a multicenter randomized trial comparing 68 Gy to 78 Gy. Int J Radiat Oncol Biol Phys. 2005 Mar 15;61(4):1019-34. doi: 10.1016/j.ijrobp.2004.07.715.
Results Reference
result
PubMed Identifier
15939547
Citation
Peeters ST, Hoogeman MS, Heemsbergen WD, Slot A, Tabak H, Koper PC, Lebesque JV. Volume and hormonal effects for acute side effects of rectum and bladder during conformal radiotherapy for prostate cancer. Int J Radiat Oncol Biol Phys. 2005 Nov 15;63(4):1142-52. doi: 10.1016/j.ijrobp.2005.03.060. Epub 2005 Jun 4.
Results Reference
result
PubMed Identifier
24246414
Citation
Heemsbergen WD, Al-Mamgani A, Slot A, Dielwart MF, Lebesque JV. Long-term results of the Dutch randomized prostate cancer trial: impact of dose-escalation on local, biochemical, clinical failure, and survival. Radiother Oncol. 2014 Jan;110(1):104-9. doi: 10.1016/j.radonc.2013.09.026. Epub 2013 Nov 15.
Results Reference
derived
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Radiotherapy for Prostate Cancer: Conventional Dose Versus High Dose
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