Prostate CancerNCT01045226
Proton Radiation Therapy in Treating Patients With Prostate Cancer
A study testing Proton Beam Radiation Therapy, Quality-of-Life assessment and Questionnaire Administration in people with Prostate Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This clinical trial is studying how well proton radiation therapy works in treating patients with prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Proton Beam Radiation Therapy, Quality-of-Life assessment and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to 17 Mar 2022
- Phase
- Interventional
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed prostate adenocarcinoma within 365 days of registration
- Clinical stages T1a-T2a N0 M0
- For any pelvic lymph node >= 1.5cm, biopsy of the lymph node is mandatory
- Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range 2-6; > 6 cores is strongly recommended; the highest Gleason score in any core reported on the pathology report will be used for determining inclusion
- PSA values < 10 ng/ml within 90 days prior to registration, done either prior to prostate biopsy or at least 21 days after prostate biopsy.
- Alkaline phosphatase within 60 days prior to registration. If alkaline phosphatase is elevated > 2 x the upper limit of institutional normal (UNL), patient must have radiological correlation to assess for metastases
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- Zubrod status 0-1 documented within 60 days of registration
- Prior androgen deprivation is allowed; however, androgen deprivation will not be continued concurrently or as an adjuvant therapy
- Patients must give IRB-approved study-specific informed consent
- Patients must complete all required tests listed within the specified time frames
- Patients must be able to start treatment within 56 days of registration
- Members of all races and ethnic groups are eligible for this trial
Who cannot join
- Clinical stages T2c or greater
- PSA of 10 ng/ml or greater
- Gleason score 7 or higher
- Evidence of distant metastasis
- Evidence of lymph node involvement
- Previous prostate cancer surgery to include: prostatectomy, hyperthermia and cryosurgery
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- Previous pelvic radiation for prostate cancer
- Androgen deprivation therapy prior to radiation is allowed; however, it is not acceptable if continued during radiation or as adjuvant therapy
- Active rectal diverticulitis, Crohn's disease, or ulcerative colitis are not allowed
- Prior systemic chemotherapy for prostate cancer
- History of proximal urethral stricture requiring dilatation
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase II Trial of Proton Radiation Therapy of Using Standard Fractionation for Low-and Low-Intermediate Risk Adenocarcinoma of the Prostate
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This clinical trial is studying how well proton radiation therapy works in treating patients with prostate cancer.
Read the detailed description
Detailed Description
PRIMARY OBJECTIVES:
- Feasibility of proton radiation therapy (RT) using standard fractionation.
SECONDARY OBJECTIVES:
- To determine freedom from failure (FFF) (vs. biochemical/clinical progression-free survival) with standard fractionation.
II. To determine the incidence of grade 2 or greater GU and GI toxicity with this regimen at 6 months, 2 years and 3 years.
III. To assess quality of life issues following completion of radiation therapy at 6 months and at 2 years.
IV. To assess incidence of impotence after the use of proton therapy at 3 years.
- To determine freedom from biochemical failure (BF) at 5 years.
VI. To determine clinical failure: local and/or distant at 5 years. VII. To determine salvage androgen deprivation (SAD) use at 5 years. VIII. To determine progression free survival: using clinical, biochemical and SAD as events at 5 years.
IX. To determine overall survival at 5 years. X. To determine disease-specific survival at 5 years.
XI. Estimate prostate and normal structures movement during RT with the use of scans.
XII. Correlate pathologic and radiologic findings with outcomes at 5 years. XIII. Correlate PSA and free PSA levels with outcomes at 5 years. XIV. Correlate testosterone levels and variation with proton therapy and outcomes at 5 years.
XV. Develop a quality assurance process for proton prostate therapy.
OUTLINE:
Patients undergo proton radiotherapy once daily 5 days a week for approximately 9 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 3 months, every 6 months for 5 years, and then annually thereafter.
- Conditions
- Prostate Cancer
- Being tested
- Proton Beam Radiation Therapy, Quality-of-Life assessment, Questionnaire Administration
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton Beam Radiation TherapyProcedure or surgery
Proton Beam Radiation Therapy
Quality-of-Life assessmentOther
Quality of Life Assessment
Questionnaire AdministrationOther
Questionnaire Administration
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients undergo proton radiotherapy once daily 5 days a week for approximately 9 weeks in the absence of disease progression or unacceptable toxicity. Receives: Procedure: Proton Beam Radiation Therapy; Other: Quality-of-Life assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
As a feasibility precaution patients will be treated and followed for a minimum of 60 days after completion of radiotherapy to determine feasibility
Measured: 5 years
Acute toxicity as assessed by NCI CTC Version 3.0
Measured: 90 days
Secondary outcomes (2)
Late toxicity as assessed by RTOG/EORTC late morbidity scoring system
Measured: 90 days
Biochemical/clinical progression-free survival
Measured: Time from start of radiotherapy to either documented increase in PSA or clinical progression of disease, death due to any cause or last patient contact alive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2010 (estimated)
- Study startAug 2009
- Primary completionDec 2020
- Study completion17 Mar 2022
Why it stopped: participants are no longer being followed up.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045226
- Sponsor's protocol ID
- UPCC 08809
- Other IDs
- NCI-2009-01500
- Status last verified
- Jan 2023
- First submitted
- 5 Jan 2010
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Proton Radiation Therapy of Using Standard Fractionation for Low-and Low-Intermediate Risk Adenocarcinoma of the Prostate
- ClinicalTrials.gov ID
- NCT01045226
- Acronym / sponsor ID
- UPCC 08809
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: participants are no longer being followed up.
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Aug 2009 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- 17 Mar 2022 (actual)
- First posted
- 8 Jan 2010 (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: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This clinical trial is studying how well proton radiation therapy works in treating patients with prostate cancer.
Detailed description
Detailed Description
PRIMARY OBJECTIVES:
- Feasibility of proton radiation therapy (RT) using standard fractionation.
SECONDARY OBJECTIVES:
- To determine freedom from failure (FFF) (vs. biochemical/clinical progression-free survival) with standard fractionation.
II. To determine the incidence of grade 2 or greater GU and GI toxicity with this regimen at 6 months, 2 years and 3 years.
III. To assess quality of life issues following completion of radiation therapy at 6 months and at 2 years.
IV. To assess incidence of impotence after the use of proton therapy at 3 years.
- To determine freedom from biochemical failure (BF) at 5 years.
VI. To determine clinical failure: local and/or distant at 5 years. VII. To determine salvage androgen deprivation (SAD) use at 5 years. VIII. To determine progression free survival: using clinical, biochemical and SAD as events at 5 years.
IX. To determine overall survival at 5 years. X. To determine disease-specific survival at 5 years.
XI. Estimate prostate and normal structures movement during RT with the use of scans.
XII. Correlate pathologic and radiologic findings with outcomes at 5 years. XIII. Correlate PSA and free PSA levels with outcomes at 5 years. XIV. Correlate testosterone levels and variation with proton therapy and outcomes at 5 years.
XV. Develop a quality assurance process for proton prostate therapy.
OUTLINE:
Patients undergo proton radiotherapy once daily 5 days a week for approximately 9 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 3 months, every 6 months for 5 years, and then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Procedure: Proton Beam Radiation Therapy, Other: Quality-of-Life assessment, Other: Questionnaire AdministrationPatients undergo proton radiotherapy once daily 5 days a week for approximately 9 weeks in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically confirmed prostate adenocarcinoma within 365 days of registration
- Clinical stages T1a-T2a N0 M0
- For any pelvic lymph node >= 1.5cm, biopsy of the lymph node is mandatory
- Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range 2-6; > 6 cores is strongly recommended; the highest Gleason score in any core reported on the pathology report will be used for determining inclusion
- PSA values < 10 ng/ml within 90 days prior to registration, done either prior to prostate biopsy or at least 21 days after prostate biopsy.
Key exclusion criteria (11 listed)
- Clinical stages T2c or greater
- PSA of 10 ng/ml or greater
- Gleason score 7 or higher
- Evidence of distant metastasis
- Evidence of lymph node involvement
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 |
|---|---|---|
| Proton Beam Radiation TherapyProton Beam Radiation Therapy | Procedure or surgery | Arm I |
| Quality-of-Life assessmentQuality of Life Assessment | Other | Arm I |
| Questionnaire AdministrationQuestionnaire Administration | Other | Arm I |
Primary outcome
As a feasibility precaution patients will be treated and followed for a minimum of 60 days after completion of radiotherapy to determine feasibility
Time frame: 5 years
Acute toxicity as assessed by NCI CTC Version 3.0
Time frame: 90 days
2 secondary outcomes
Late toxicity as assessed by RTOG/EORTC late morbidity scoring system
Time frame: 90 days
Biochemical/clinical progression-free survival
Time frame: Time from start of radiotherapy to either documented increase in PSA or clinical progression of disease, death due to any cause or last patient contact alive
Results and safety
The study was stopped early (reason given: participants are no longer being followed up.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proton Beam Radiation Therapy, Quality-of-Life assessment and Questionnaire Administration in people with Prostate Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
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 12 inclusion and 11 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: stopped early, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study was stopped early (reason given: participants are no longer being followed up.). Results are not available in the source record.
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?
As a feasibility precaution patients will be treated and followed for a minimum of 60 days after completion of radiotherapy to determine feasibility (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2023.