Radiotherapy for Prostate Cancer: Conventional Dose Versus High Dose

Prostatic Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00692107
• Other study ID #: CKVO 96-10
• Status: Completed
• Phase: Phase 3
• First received: August 25, 2005
• Last updated: June 5, 2008
• Start date: June 1997
• Est. completion date: December 2007

Study information

• Verified date: June 2008
• Source: The Netherlands Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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;

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 669
• Est. completion date: December 2007
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Radiation:
• Gray
68 Gy vs. 78 Gy
• Gray
68 Gy vs. 78 Gy

Locations

Country	Name	City	State
Netherlands	The Netherlands Cancer Institute	Amsterdam
Netherlands	Radiotherapeutic Institute Friesland	Leeuwarden
Netherlands	Daniel Den Hoed Cancer Center	Rotterdam
Netherlands	Zeeuws Radiotherapeutic Institute	Vlissingen

Sponsors (3)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute	Dutch Cancer Society, Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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 Ph — View 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):11 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from failure
Secondary	Toxicity
Secondary	Overall survival
Secondary	Freedom from clinical failure