Prostate CancerPhase 3NCT00002703
Radiation Therapy in Treating Patients With Stage I or Stage II Prostate Cancer
A Phase 3 study testing high-LET heavy ion therapy and low-LET photon therapy in people with Prostate Cancer, run by Proton Radiation Oncology Group at 2 sites in United States.
Trial summary
RATIONALE: Radiation therapy uses high energy x-rays to damage tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of conventional radiation therapy with high-dose radiation therapy in treating men with stage I or stage II prostate cancer. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- high-LET heavy ion therapy and low-LET photon therapy
- Type of treatment
- Surgery or procedure
- How many people
- 390 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 1996to Sep 2005
- 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
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Primary tumor confined to prostate TNM clinical Stages T1b-c or T2a-b No T1a No T1b-c tumor with Gleason grade 1-2/5 No Gleason grade 1-2/5 and PSA less than 4 ng/mL Nodes negative on imaging (Nx) or by surgical sampling (N0) PSA no greater than 15 ng/mL Treatment must begin within 28 days after randomization
PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 70%-100% Life expectancy: Greater than 10 years Other: No major medical or psychiatric illness that precludes protocol entry No prior or concurrent second malignancy within 5 years except basal cell skin cancer
PRIOR CONCURRENT THERAPY: No prior treatment for prostate cancer
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Loma Linda University Medical Center
Loma Linda, California, 92354
About this study
Official title: A PHASE III TRIAL EMPLOYING CONFORMAL PHOTONS WITH PROTON BOOST IN EARLY STAGE PROSTATE CANCER: CONVENTIONAL DOSE COMPARED TO HIGH DOSE IRRADIATION
RATIONALE: Radiation therapy uses high energy x-rays to damage tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of conventional radiation therapy with high-dose radiation therapy in treating men with stage I or stage II prostate cancer.
Read the detailed description
OBJECTIVES: I. Determine whether high-dose radiotherapy using conformal photons with a proton boost produces a 20% increase in the proportion of Stage I/II prostate cancer free from local failure and biochemical relapse at 5 years when compared to results of conventional-dose radiotherapy. II. Determine whether high-dose radiotherapy produces a 33% reduction in the cumulative incidence of a rising PSA (second hormone failure) following hormone therapy given at the time of first PSA/clinical failure when compared with conventional-dose radiotherapy. IV. Assess the relative rectal, bladder, and sexual morbidity of conformal photon doses of 70.2 and 79.2 Gy in these patients. V. Collect, in a prospective manner, paraffin biopsy blocks for subsequent analysis of emerging molecular pathologic predictors of outcome in three patients.
OUTLINE: Randomized study. Arm I: Radiotherapy. Boost to the prostate using high-LET protons followed by irradiation of the prostate, periprostatic tissues, and seminal vesicles using conformal photons with energies greater than 6 MV. Conventional dose. Arm II: Radiotherapy. As in Arm I. High dose.
PROJECTED ACCRUAL: There will be 390 patients accrued into this study over 3 years. An additional 3.5 years will be required for follow-up.
- Conditions
- Prostate Cancer
- Being tested
- high-LET heavy ion therapy, low-LET photon therapy
- Keywords
- adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-LET heavy ion therapyRadiation
low-LET photon therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2004 (estimated)
- Study startJan 1996
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Proton Radiation Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Anthony L. Zietman, MD, Study chair, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002703
- Sponsor's protocol ID
- CDR0000064503
- Other IDs
- PROG-9509
- Status last verified
- Apr 2012
- First submitted
- 1 Nov 1999
- Last updated
- 6 Nov 2013
- Results posted
- No
Publications
Coen JJ, Zietman AL, Rossi CJ, Grocela JA, Efstathiou JA, Yan Y, Shipley WU. Comparison of high-dose proton radiotherapy and brachytherapy in localized prostate cancer: a case-matched analysis. Int J Radiat Oncol Biol Phys. 2012 Jan 1;82(1):e25-31. doi: 10.1016/j.ijrobp.2011.01.039. Epub 2011 Apr 4.
PubMed 21470787Nguyen PL, Chen RC, Hoffman KE, Trofimov A, Efstathiou JA, Coen JJ, Shipley WU, Zietman AL, Talcott JA. Rectal dose-volume histogram parameters are associated with long-term patient-reported gastrointestinal quality of life after conventional and high-dose radiation for prostate cancer: a subgroup analysis of a randomized trial. Int J Radiat Oncol Biol Phys. 2010 Nov 15;78(4):1081-5. doi: 10.1016/j.ijrobp.2009.09.015. Epub 2010 Mar 6.
PubMed 20207497Zietman AL, Bae K, Slater JD, Shipley WU, Efstathiou JA, Coen JJ, Bush DA, Lunt M, Spiegel DY, Skowronski R, Jabola BR, Rossi CJ. Randomized trial comparing conventional-dose with high-dose conformal radiation therapy in early-stage adenocarcinoma of the prostate: long-term results from proton radiation oncology group/american college of radiology 95-09. J Clin Oncol. 2010 Mar 1;28(7):1106-11. doi: 10.1200/JCO.2009.25.8475. Epub 2010 Feb 1.
PubMed 20124169Rossi CJ, Zietman AL, DeSilvio M, et al.: A randomized trial comparing conventional dose (70.2GyE) and high-dose (79.2GyE) conformal radiation in early stage adenocarcinoma of the prostate: results of an interim analysis of PROG 95-09. [Abstract] American Society of Clinical Oncology 2005 Prostate Cancer Symposium, 17-19 February 2005, Orlando, Florida. A-58, 2005.
Zietman AL, DeSilvio ML, Slater JD, Rossi CJ Jr, Miller DW, Adams JA, Shipley WU. Comparison of conventional-dose vs high-dose conformal radiation therapy in clinically localized adenocarcinoma of the prostate: a randomized controlled trial. JAMA. 2005 Sep 14;294(10):1233-9. doi: 10.1001/jama.294.10.1233.
PubMed 16160131Zietman AL, DeSilvio M, Slater JD, et al.: A randomized trial comparing conventional dose (70.2GyE) and high-dose (79. 2GyE) conformal radiation in early stage adenocarcinoma of the prostate: results of an interim analysis of PROG 95-09. [Abstract] Int J Radiat Oncol Biol Phys 60 (Suppl 1): A-4, S131, 2004.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE III TRIAL EMPLOYING CONFORMAL PHOTONS WITH PROTON BOOST IN EARLY STAGE PROSTATE CANCER: CONVENTIONAL DOSE COMPARED TO HIGH DOSE IRRADIATION
- ClinicalTrials.gov ID
- NCT00002703
- Acronym / sponsor ID
- CDR0000064503
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Proton Radiation Oncology GroupUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 1996
- Study completion
- Sep 2005 (actual)
- First posted
- 1 Sep 2004 (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.
RATIONALE: Radiation therapy uses high energy x-rays to damage tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of conventional radiation therapy with high-dose radiation therapy in treating men with stage I or stage II prostate cancer.
Detailed description
OBJECTIVES: I. Determine whether high-dose radiotherapy using conformal photons with a proton boost produces a 20% increase in the proportion of Stage I/II prostate cancer free from local failure and biochemical relapse at 5 years when compared to results of conventional-dose radiotherapy. II. Determine whether high-dose radiotherapy produces a 33% reduction in the cumulative incidence of a rising PSA (second hormone failure) following hormone therapy given at the time of first PSA/clinical failure when compared with conventional-dose radiotherapy. IV. Assess the relative rectal, bladder, and sexual morbidity of conformal photon doses of 70.2 and 79.2 Gy in these patients. V. Collect, in a prospective manner, paraffin biopsy blocks for subsequent analysis of emerging molecular pathologic predictors of outcome in three patients.
OUTLINE: Randomized study. Arm I: Radiotherapy. Boost to the prostate using high-LET protons followed by irradiation of the prostate, periprostatic tissues, and seminal vesicles using conformal photons with energies greater than 6 MV. Conventional dose. Arm II: Radiotherapy. As in Arm I. High dose.
PROJECTED ACCRUAL: There will be 390 patients accrued into this study over 3 years. An additional 3.5 years will be required for follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| high-LET heavy ion therapy | Radiation | – |
| low-LET photon therapy | Radiation | – |
Primary outcome
Not reported in the source record.
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 Nov 2013.
- Results publication: PubMed 21470787Coen JJ, Zietman AL, Rossi CJ, Grocela JA, Efstathiou JA, Yan Y, Shipley WU. Comparison of high-dose proton radiotherapy and brachytherapy in localized prostate cancer: a case-matched analysis. Int J Radiat Oncol Biol Phys. 2012 Jan 1;82(1):e25-31. doi: 10.1016/j.ijrobp.2011.01.039. Epub 2011 Apr 4.
- Results publication: PubMed 20207497Nguyen PL, Chen RC, Hoffman KE, Trofimov A, Efstathiou JA, Coen JJ, Shipley WU, Zietman AL, Talcott JA. Rectal dose-volume histogram parameters are associated with long-term patient-reported gastrointestinal quality of life after conventional and high-dose radiation for prostate cancer: a subgroup analysis of a randomized trial. Int J Radiat Oncol Biol Phys. 2010 Nov 15;78(4):1081-5. doi: 10.1016/j.ijrobp.2009.09.015. Epub 2010 Mar 6.
- Results publication: PubMed 20124169Zietman AL, Bae K, Slater JD, Shipley WU, Efstathiou JA, Coen JJ, Bush DA, Lunt M, Spiegel DY, Skowronski R, Jabola BR, Rossi CJ. Randomized trial comparing conventional-dose with high-dose conformal radiation therapy in early-stage adenocarcinoma of the prostate: long-term results from proton radiation oncology group/american college of radiology 95-09. J Clin Oncol. 2010 Mar 1;28(7):1106-11. doi: 10.1200/JCO.2009.25.8475. Epub 2010 Feb 1.
- Results publicationRossi CJ, Zietman AL, DeSilvio M, et al.: A randomized trial comparing conventional dose (70.2GyE) and high-dose (79.2GyE) conformal radiation in early stage adenocarcinoma of the prostate: results of an interim analysis of PROG 95-09. [Abstract] American Society of Clinical Oncology 2005 Prostate Cancer Symposium, 17-19 February 2005, Orlando, Florida. A-58, 2005.
- Results publication: PubMed 16160131Zietman AL, DeSilvio ML, Slater JD, Rossi CJ Jr, Miller DW, Adams JA, Shipley WU. Comparison of conventional-dose vs high-dose conformal radiation therapy in clinically localized adenocarcinoma of the prostate: a randomized controlled trial. JAMA. 2005 Sep 14;294(10):1233-9. doi: 10.1001/jama.294.10.1233.
- Results publicationZietman AL, DeSilvio M, Slater JD, et al.: A randomized trial comparing conventional dose (70.2GyE) and high-dose (79. 2GyE) conformal radiation in early stage adenocarcinoma of the prostate: results of an interim analysis of PROG 95-09. [Abstract] Int J Radiat Oncol Biol Phys 60 (Suppl 1): A-4, S131, 2004.
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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.
Anthony L. Zietman, MD study chair
Massachusetts General Hospital
2 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 high-LET heavy ion therapy and low-LET photon therapy in people with Prostate Cancer, run by Proton Radiation Oncology Group at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002703, which also lists 6 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 Nov 2013.