Prostate CancerNCT00573833
Internal Radiation Therapy in Treating Patients With Prostate Cancer
A study testing questionnaire administration, quality-of-life assessment and brachytherapy in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. PURPOSE: This clinical trial is studying the side effects and how well internal radiation therapy works in treating patients with prostate cancer. Read more about this study
- Who is it for?
- Ages 18 to 120 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- questionnaire administration, quality-of-life assessment and brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 120 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Intermediate-risk adenocarcinoma of the prostate, defined by 1of the following criteria:
- PSA 10-20 ng/mL
- Gleason score ≥ 7
- Stage ≥ T2b AND < T3
- Less than 20% risk of seminal vesicle involvement or lymph node involved based upon the Kattan nomogram (pre-treatment risk with IMRT)
- Prostate size < 60 cc by MRI or CT imaging
- International Prostate Symptom Score Index ≤ 15
Who cannot join
- Evidence of definitive extracapsular extension/seminal vesicle invasion or pelvic adenopathy by MRI (endorectal coil) and DRE (digital rectal examination)
- Suspected extracapsular disease will not be considered an exclusion criteria
- PSA > 20 ng/mL
- Presence of distant metastases
- PATIENT CHARACTERISTICS:
- WBC ≥ 3,500/mm³
Show all 23Show fewer
- Platelet count ≥ 75,000/mm³
- Hemoglobin ≥ 10 g/dL
- Creatinine ≤ 1.5 mg/dL
- Liver function tests ≤ 1.5 times normal
- INR ≤ 2.5
- Able to complete quality of life questionnaires
- Able to give informed consent
- No active perineal infections
- No history of urethral stricture
- No prior history of pelvic malignancy
- No prior history of lymphoma disease, ulcerative colitis, or anal fissures
- No contraindications to general anesthesia
- No pacemaker
- PRIOR CONCURRENT THERAPY:
- No prior transurethral resection of the prostate
- No prior pelvic radiotherapy
- No prior treatment for prostate cancer except for hormone therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Pilot Study of High Dose Rate Brachytherapy as Definitive Management for Intermediate Risk Prostate Cancer
RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells.
PURPOSE: This clinical trial is studying the side effects and how well internal radiation therapy works in treating patients with prostate cancer.
Read the detailed description
OBJECTIVES:
Primary
- To assess the feasibility of high-dose rate (HDR) brachytherapy (without the use of external-beam radiotherapy) as definitive treatment for patients with intermediate-risk prostate cancer.
- To assess acceptable toxicity, defined as treatment related toxicity (urinary and rectal), no worse than that seen by patients treated with conventional therapy (grade 3 urinary toxicity < 10% and grade 3 rectal toxicity < 10%).
Secondary
- To achieve adequate dosimetric coverage of the prostate comparable to current standards.
- To assess the effect of treatment on sexual function.
OUTLINE: Patients undergo 4 high-dose rate brachytherapy treatments over 2 days.
Patients complete bladder, bowel, sexual function, and quality of life questionnaires, including the International Index of Erectile Function (IIEF) questionnaire, the International Prostate Symptom Score Index (IPSS), and the MSKCC Prostate Quality of Life questionnaire at baseline and then at every follow-up visit.
After completion of study treatment, patients are followed every 3 months for 1 year.
- Conditions
- Prostate Cancer
- Being tested
- questionnaire administration, quality-of-life assessment, brachytherapy
- Keywords
- adenocarcinoma of the prostate, 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.
questionnaire administrationOther
quality-of-life assessmentProcedure or surgery
brachytherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| HDR Brachytherapy | Experimental | 9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days Receives: Other: questionnaire administration; Procedure: quality-of-life assessment; Radiation: brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With an Acceptable Level of Severe Toxicity as Defined at < Grade 3 CTC Toxicity
Feasibility will be defined as an acceptable level of severe toxicity (both acute and late effects), and adequate dosimetric coverage. Severe toxicity will be defined as > or = grade 3 NCI CTC toxicity
Measured: At scheduled 3 month intervals for one year
Number of Patients With an Acceptable Level of Treatment Related Urinary and Rectal Toxicity as Defined at < Grade 3 CTC Toxicity
urinary and rectal toxicity-see the adverse event tables
Measured: Within 90 days of treatment (early toxicities) or after 90 days (late toxicities)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2007 (estimated)
- Study startNov 2007
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Josh Yamada, MD, Principal investigator, Memorial Sloan Kettering Cancer CenterMichael J. Zelefsky, MD, Principal investigator, Memorial Sloan Kettering Cancer CenterSherri M. Donat, MD, Principal investigator, Memorial Sloan Kettering Cancer CenterMarco Zaider, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00573833
- Sponsor's protocol ID
- 07-120
- Other IDs
- MSKCC-07120
- Status last verified
- Sep 2017
- First submitted
- 13 Dec 2007
- Last updated
- 20 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of High Dose Rate Brachytherapy as Definitive Management for Intermediate Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT00573833
- Acronym / sponsor ID
- 07-120
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2007
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 14 Dec 2007 (estimated)
- Results
- Posted 20 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells.
PURPOSE: This clinical trial is studying the side effects and how well internal radiation therapy works in treating patients with prostate cancer.
Detailed description
OBJECTIVES:
Primary
- To assess the feasibility of high-dose rate (HDR) brachytherapy (without the use of external-beam radiotherapy) as definitive treatment for patients with intermediate-risk prostate cancer.
- To assess acceptable toxicity, defined as treatment related toxicity (urinary and rectal), no worse than that seen by patients treated with conventional therapy (grade 3 urinary toxicity < 10% and grade 3 rectal toxicity < 10%).
Secondary
- To achieve adequate dosimetric coverage of the prostate comparable to current standards.
- To assess the effect of treatment on sexual function.
OUTLINE: Patients undergo 4 high-dose rate brachytherapy treatments over 2 days.
Patients complete bladder, bowel, sexual function, and quality of life questionnaires, including the International Index of Erectile Function (IIEF) questionnaire, the International Prostate Symptom Score Index (IPSS), and the MSKCC Prostate Quality of Life questionnaire at baseline and then at every follow-up visit.
After completion of study treatment, patients are followed every 3 months for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HDR Brachytherapy | Experimental | Other: questionnaire administration, Procedure: quality-of-life assessment, Radiation: brachytherapy9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Intermediate-risk adenocarcinoma of the prostate, defined by 1of the following criteria:
- Less than 20% risk of seminal vesicle involvement or lymph node involved based upon the Kattan nomogram (pre-treatment risk with IMRT)
- Prostate size < 60 cc by MRI or CT imaging
- International Prostate Symptom Score Index ≤ 15
Key exclusion criteria (23 listed)
- Evidence of definitive extracapsular extension/seminal vesicle invasion or pelvic adenopathy by MRI (endorectal coil) and DRE (digital rectal examination)
- PSA > 20 ng/mL
- Presence of distant metastases
- WBC ≥ 3,500/mm³
- Platelet count ≥ 75,000/mm³
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 |
|---|---|---|
| questionnaire administration | Other | HDR Brachytherapy |
| quality-of-life assessment | Procedure or surgery | HDR Brachytherapy |
| brachytherapy | Radiation | HDR Brachytherapy |
Primary outcome
Number of Patients With an Acceptable Level of Severe Toxicity as Defined at < Grade 3 CTC Toxicity
Time frame: At scheduled 3 month intervals for one year
Feasibility will be defined as an acceptable level of severe toxicity (both acute and late effects), and adequate dosimetric coverage. Severe toxicity will be defined as > or = grade 3 NCI CTC toxicity
Number of Patients With an Acceptable Level of Treatment Related Urinary and Rectal Toxicity as Defined at < Grade 3 CTC Toxicity
Time frame: Within 90 days of treatment (early toxicities) or after 90 days (late toxicities)
urinary and rectal toxicity-see the adverse event tables
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Josh Yamada, MD principal investigator
Memorial Sloan Kettering Cancer Center
Michael J. Zelefsky, MD principal investigator
Memorial Sloan Kettering Cancer Center
Sherri M. Donat, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionnaire administration, quality-of-life assessment and brachytherapy in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center 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 7 inclusion and 23 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 20 Oct 2017. 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?
Yes. Results are posted in the registry (first posted 20 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients With an Acceptable Level of Severe Toxicity as Defined at < Grade 3 CTC Toxicity (time frame: At scheduled 3 month intervals for one year). 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 20 Oct 2017.