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Radiotherapy for Prostate Cancer: Conventional Dose Versus High Dose

NCT ID: NCT00692107

Last Updated: 2008-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

669 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-06-30

Study Completion Date

2007-12-31

Brief Summary

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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

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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.

Conditions

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Prostatic Neoplasms

Keywords

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Radiotherapy Dose

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

68 Gy

Group Type ACTIVE_COMPARATOR

Gray

Intervention Type RADIATION

68 Gy vs. 78 Gy

2

78 Gy

Group Type EXPERIMENTAL

Gray

Intervention Type RADIATION

68 Gy vs. 78 Gy

Interventions

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Gray

68 Gy vs. 78 Gy

Intervention Type RADIATION

Gray

68 Gy vs. 78 Gy

Intervention Type RADIATION

Eligibility Criteria

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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
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Erasmus Medical Center

OTHER

Sponsor Role collaborator

Dutch Cancer Society

OTHER

Sponsor Role collaborator

The Netherlands Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Erasmus Medical Center / The Netherlands Cancer Institute

Principal Investigators

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Joos V Lebesque, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Netherlands Cancer Institute

Locations

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The Netherlands Cancer Institute

Amsterdam, , Netherlands

Site Status

Zeeuws Radiotherapeutic Institute

Flushing, , Netherlands

Site Status

Radiotherapeutic Institute Friesland

Leeuwarden, , Netherlands

Site Status

Daniel Den Hoed Cancer Center

Rotterdam, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type RESULT
PMID: 15752881 (View on PubMed)

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.

Reference Type RESULT
PMID: 15939547 (View on PubMed)

Kim S, Kong JH, Lee Y, Lee JY, Kang TW, Kong TH, Kim MH, You SH. Dose-escalated radiotherapy for clinically localized and locally advanced prostate cancer. Cochrane Database Syst Rev. 2023 Mar 8;3(3):CD012817. doi: 10.1002/14651858.CD012817.pub2.

Reference Type DERIVED
PMID: 36884035 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24246414 (View on PubMed)

Other Identifiers

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CKVO 96-10

Identifier Type: -

Identifier Source: org_study_id