Prostatic NeoplasmsPhase 3NCT00692107
Radiotherapy for Prostate Cancer: Conventional Dose Versus High Dose
A Phase 3 study testing Gray in people with Prostatic Neoplasms, run by The Netherlands Cancer Institute at 4 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- Gray
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 669 participants
- Where
- 4 sitesNetherlands
- Study dates
- Jun 1997to Dec 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- distant metastases
- positive regional lymph nodes proven by surgical or cytological sampling
- on anticoagulants
- previous prostatectomy
- previous pelvic irradiation
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
The Netherlands Cancer Institute
Amsterdam, 1066CX
Zeeuws Radiotherapeutic Institute
Flushing, 4382 EE
Radiotherapeutic Institute Friesland
Leeuwarden, 8934 AD
Daniel Den Hoed Cancer Center
Rotterdam, 3075 EA
About this study
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
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;
Read the 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.
- Conditions
- Prostatic Neoplasms
- Being tested
- Gray
- Keywords
- Radiotherapy, Dose
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GrayRadiation
68 Gy vs. 78 Gy
GrayRadiation
68 Gy vs. 78 Gy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 68 Gy Receives: Radiation: Gray |
| 2 | Experimental | 78 Gy Receives: Radiation: Gray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from failure
Secondary outcomes (3)
Toxicity
Overall survival
Freedom from clinical failure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startJun 1997
- Primary completionMay 2005
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 669 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center, Dutch Cancer Society
- Investigators
- Joos V Lebesque, MD, PhD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692107
- Sponsor's protocol ID
- CKVO 96-10
- Status last verified
- Jun 2008
- First submitted
- 25 Aug 2005
- Last updated
- 6 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15752881Peeters 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.
PubMed 15939547Kim 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.
PubMed 36884035Heemsbergen 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.
PubMed 24246414
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00692107
- Acronym / sponsor ID
- CKVO 96-10
- Conditions
- Prostatic Neoplasms
- Keywords
- Radiotherapy, Dose
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 669 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- Erasmus Medical Center, Dutch Cancer Society
- Study start
- Jun 1997
- Primary completion
- May 2005 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 6 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Radiation: Gray68 Gy |
| 2 | Experimental | Radiation: Gray78 Gy |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- distant metastases
- positive regional lymph nodes proven by surgical or cytological sampling
- on anticoagulants
- previous prostatectomy
- previous pelvic irradiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gray68 Gy vs. 78 Gy | Radiation | 1 |
| Gray68 Gy vs. 78 Gy | Radiation | 2 |
Primary outcome
Freedom from failure
3 secondary outcomes
Toxicity
Overall survival
Freedom from clinical failure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2008.
- Results publication: PubMed 15752881Peeters 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 publication: PubMed 15939547Peeters 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.
- Derived from this study: PubMed 36884035Kim 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.
- Derived from this study: PubMed 24246414Heemsbergen 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.
Related trials for Prostatic Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joos V Lebesque, MD, PhD principal investigator
The Netherlands Cancer Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gray in people with Prostatic Neoplasms, run by The Netherlands Cancer Institute at 4 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from failure. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00692107, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2008.