Prostate CancerPhase 2NCT00714753
Internal Radiation Therapy With or Without External-Beam Radiation Therapy in Treating Patients With Localized Prostate Cancer
A Phase 2 study testing brachytherapy, hypofractionated radiation therapy and image-guided radiation therapy in people with Prostate Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. 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. 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?
- brachytherapy, hypofractionated radiation therapy and image-guided radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Dec 2013
- Phase
- Phase 2
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate, meeting one of the following criteria:
- Low-risk disease (T1-T2a, Gleason score ≤ 6, and PSA < 10 ng/mL)
- Low intermediate-risk disease (T1-T2c, Gleason score ≤ 6, and PSA < 20 ng/mL OR T1-T2a, Gleason score 7, and PSA < 10 ng/mL)
- No known nodal (N0 or NX) or distant (M0 or MX) metastases
- No pubic arch interference, as defined by either of the following:
- Maximum transrectal ultrasound-determined anterior-posterior (z-axis) dimension < 4.3 cm
- No more than 25% prostate volume blocked (by pubic arch) on CT scan simulation at A10°I beam's eye view
- Prostate planimetry volume ≤ 60 cc as determined by step-section transrectal ultrasound
- American Urological Association voiding symptom index ≤ 12
- Peak uroflow rate (Q_max) ≥ 12 cc/second
- Post-void ultrasound bladder residual volume ≤ 100 cc
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-1
- Life expectancy ≥ 5 years
- WBC > 2,000/μL
- Platelet count > 100,000/μL
- PT < 1.5 times upper limit of normal
- No diabetes mellitus associated with vascular ulcers or wound-healing problems
- No blood dyscrasias
- No inflammatory bowel disease
- No connective tissue disorder
- No other prior or concurrent invasive malignancy (except nonmelanoma skin cancer) or lymphomatous or hematological malignancy (except chronic lymphocytic leukemia/lymphoma) unless patient has been continually disease-free for ≥ 5 years
- No medical or psychiatric condition that would preclude giving informed consent or complying with study treatment
- Able to undergo anesthesia
PRIOR CONCURRENT THERAPY:
- No prior transurethral resection of the prostate
- No prior prostatic cryoablation or high-intensity focused ultrasound
- No prior prostatectomy
- No prior prostatic enucleation
- No prior pelvic external beam radiotherapy
- No prior radionuclide prostate brachytherapy
- No prior hemi- or total hip arthroplasty
- Neoadjuvant androgen suppression therapy allowed provided it was initiated 2-6 months prior to study entry and its total duration is ≤ 6 months
- No concurrent anticoagulation therapy, including heparin or coumadin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Evaluation of High Dose-Rate Brachytherapy ± Image-Guided Intensity Modulated Hypofractionated External Radiotherapy for Localized Prostate Cancer
RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. 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 phase II trial is studying the side effects of internal radiation therapy when given with or without external-beam radiation therapy and to see how well it works in treating patients with localized prostate cancer.
Read the detailed description
OBJECTIVES:
Primary
- Evaluate the tolerability of 2 radiotherapeutic regimens (high dose-rate brachytherapy [HDR] with or without image-guided intensity-modulated hypofractionated external beam radiotherapy [EBRT]), as measured by the Common Terminology Criteria for Adverse Events (CTCAE v3.0), in patients with localized prostate cancer.
Secondary
- Identify any associations between dose-volume parameters for organs at risk and the rate and severity of genitourinary or gastrointestinal adverse events.
- Evaluate patient preference with regard to selection of a second treatment (a second HDR brachytherapy session or an EBRT session).
- Evaluate patient-reported health-related quality of life (HRQOL) as measured by validated HRQOL instruments for 5 years.
- Describe the probability of freedom from biochemical and clinical failure.
- Describe the probability of freedom from salvage androgen suppression.
OUTLINE: Patients undergo high dose-rate (HDR) brachytherapy (2 fractions ≥ 5 hours apart). Beginning 2-4 weeks after completion of the first HDR brachytherapy session, patients undergo either a second session of HDR brachytherapy (2 fractions ≥ 5 hours apart) OR image-guided intensity-modulated hypofractionated external beam radiotherapy once daily 5 days a week for 3 weeks.
Quality of life is assessed at baseline, prior to the second treatment session, at 1 and 6 months after completion of treatment, every 6 months for 3 years, and then annually for 2 years.
After completion of study treatment, patients are followed at 1 and 6 months, every 6 months for 3 years, and then annually for 2 years.
- Conditions
- Prostate Cancer
- Being tested
- brachytherapy, hypofractionated radiation therapy, image-guided radiation therapy, intensity-modulated radiation therapy
- Keywords
- stage I prostate cancer, stage II prostate cancer, adenocarcinoma of the prostate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brachytherapyRadiation
hypofractionated radiation therapyRadiation
image-guided radiation therapyRadiation
intensity-modulated radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Protocol treatment consists of either two high dose-rate (HDR) brachytherapy implantation sessions or one HDR brachytherapy session followed by external beam radiotherapy (EBRT). Each HDR session consists of two 9.5Gy fractions. After the first HDR session of two fractions, patients express a preference for: (1) a second HDR brachytherapy implantation session, or (2) EBRT. The second HDR session or EBRT will begin 2-4 weeks after the first HDR brachytherapy session. Receives: Radiation: brachytherapy; Radiation: hypofractionated radiation therapy; Radiation: image-guided radiation therapy; Radiation: intensity-modulated radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Tolerance (Genitourinary [GU] or Gastrointestinal [GI] Adverse Events)
Separately evaluate the tolerance of 2 radiotherapeutic regimens (HDR alone and HDR followed by hypofractionated EBRT) using the Common Terminology Criteria for Adverse Events (CTCAE v3.0). The specific adverse events (AEs) are early (i.e., within 270 days of treatment completion) grade >3 genitourinary (GU) and/or gastrointestinal (GI) AEs, late grade 2 GU and GI AEs, and late grade ≥3 GU and GI AEs.
Measured: From baseline to 3 years after registration
Secondary outcomes (5)
Association Between Dose-volume Limitations for Organs at Risk and Rate and Severity of GU or GI Adverse Events
Dose-volume limitations for organs at risk will be analyzed byassociating GU or GI AEs (both rate and severity) with dosimetric parameters using simple correlational methods. These parameters will include (1) bladder V80, V60, V50, and Dmax; (2) penile bulb median dose; (3) rectum V80, V60, V50 and Dmax; and (4) urethra V120, V110, V100, and Dmax.
Measured: From baseline to 5 years after registration
Patient Preference for a Second Treatment (a Second High Dose-rate Brachytherapy Session or an External Beam Radiotherapy Session)
Patient preference for second treatment (group 1 or group 2) will be assessed using a Treatment Preference Questionnaire (Appendix IX) developed specifically for this study. Qualitative and quantitative analyses will be performed on patient responses to the questions posed after choosing their second treatment in an exploratory fashion.
Measured: From baseline until the end of the first treatment
Changes in Health-related Quality of Life Scores
A pretest-posttest design will be employed to detect changes in HRQOL scores over time. The HRQOL scores will be calculated per assessment, as appropriate. Each construct will be standardized to a range of 0-100 so that comparison across constructs is facilitated. Sets of difference scores will be computed: 1) differences between baseline and treatment completion (at 1 month post treatment follow up), and 2) differences between treatment completion and all post-treatment follow-up examinations for up to five years after finishing the protocol treatment (see Section 4.1 for specific HRQOL instruments to be completed at follow-up visits). The first analysis will allow for determination of the short-term impact of treatment on HRQOL, while the second will investigate the long-term treatment effect. Student's t-test methodology will be applied to the differences at end of treatment (1 month post treatment follow up) and at each follow-up.
Measured: From baseline to 5 years after registration
Freedom From Biochemical and Clinical Failure
Freedom from biochemical and clinical failure, will be analyzed using Kaplan-Meier procedures. Estimates will be drawn from the Kaplan-Meier curves for the probability of freedom from biochemical and clinical failure.
Measured: From baseline to 5 years after registration
Freedom From Salvage Androgen Suppression Treatment
Estimates will be drawn from the Kaplan-Meier curves for the probability of freedom from salvage androgen suppression therapy.
Measured: From baseline to 5 years after registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startAug 2008
- Primary completionDec 2013
- Study completionDec 2013
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 Mayo ClinicThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Thomas M. Pisansky, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00714753
- Sponsor's protocol ID
- CDR0000600446
- Other IDs
- P30CA015083, MC0652, 08-001451
- Status last verified
- Aug 2018
- First submitted
- 11 Jul 2008
- Last updated
- 7 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of High Dose-Rate Brachytherapy ± Image-Guided Intensity Modulated Hypofractionated External Radiotherapy for Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT00714753
- Acronym / sponsor ID
- CDR0000600446
- Conditions
- Prostate Cancer
- Keywords
- stage I prostate cancer, stage II prostate cancer, adenocarcinoma of the prostate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 14 Jul 2008 (estimated)
- Results
- Posted 12 Sep 2018
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 uses radioactive material placed directly into or near a tumor to kill tumor cells. 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 phase II trial is studying the side effects of internal radiation therapy when given with or without external-beam radiation therapy and to see how well it works in treating patients with localized prostate cancer.
Detailed description
OBJECTIVES:
Primary
- Evaluate the tolerability of 2 radiotherapeutic regimens (high dose-rate brachytherapy [HDR] with or without image-guided intensity-modulated hypofractionated external beam radiotherapy [EBRT]), as measured by the Common Terminology Criteria for Adverse Events (CTCAE v3.0), in patients with localized prostate cancer.
Secondary
- Identify any associations between dose-volume parameters for organs at risk and the rate and severity of genitourinary or gastrointestinal adverse events.
- Evaluate patient preference with regard to selection of a second treatment (a second HDR brachytherapy session or an EBRT session).
- Evaluate patient-reported health-related quality of life (HRQOL) as measured by validated HRQOL instruments for 5 years.
- Describe the probability of freedom from biochemical and clinical failure.
- Describe the probability of freedom from salvage androgen suppression.
OUTLINE: Patients undergo high dose-rate (HDR) brachytherapy (2 fractions ≥ 5 hours apart). Beginning 2-4 weeks after completion of the first HDR brachytherapy session, patients undergo either a second session of HDR brachytherapy (2 fractions ≥ 5 hours apart) OR image-guided intensity-modulated hypofractionated external beam radiotherapy once daily 5 days a week for 3 weeks.
Quality of life is assessed at baseline, prior to the second treatment session, at 1 and 6 months after completion of treatment, every 6 months for 3 years, and then annually for 2 years.
After completion of study treatment, patients are followed at 1 and 6 months, every 6 months for 3 years, and then annually for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Radiation: brachytherapy, Radiation: hypofractionated radiation therapy, Radiation: image-guided radiation therapy, Radiation: intensity-modulated radiation therapyProtocol treatment consists of either two high dose-rate (HDR) brachytherapy implantation sessions or one HDR brachytherapy session followed by external beam radiotherapy (EBRT). Each HDR session consists of two 9.5Gy fractions. After the first HDR session of two fractions, patients express a preference for: (1) a second HDR brachytherapy implantation session, or (2) EBRT. The second HDR session or EBRT will begin 2-4 weeks after the first HDR brachytherapy session. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| brachytherapy | Radiation | Intervention Group |
| hypofractionated radiation therapy | Radiation | Intervention Group |
| image-guided radiation therapy | Radiation | Intervention Group |
| intensity-modulated radiation therapy | Radiation | Intervention Group |
Primary outcome
Treatment Tolerance (Genitourinary [GU] or Gastrointestinal [GI] Adverse Events)
Time frame: From baseline to 3 years after registration
Separately evaluate the tolerance of 2 radiotherapeutic regimens (HDR alone and HDR followed by hypofractionated EBRT) using the Common Terminology Criteria for Adverse Events (CTCAE v3.0). The specific adverse events (AEs) are early (i.e., within 270 days of treatment completion) grade >3 genitourinary (GU) and/or gastrointestinal (GI) AEs, late grade 2 GU and GI AEs, and late grade ≥3 GU and GI AEs.
5 secondary outcomes
Association Between Dose-volume Limitations for Organs at Risk and Rate and Severity of GU or GI Adverse Events
Time frame: From baseline to 5 years after registration
Patient Preference for a Second Treatment (a Second High Dose-rate Brachytherapy Session or an External Beam Radiotherapy Session)
Time frame: From baseline until the end of the first treatment
Changes in Health-related Quality of Life Scores
Time frame: From baseline to 5 years after registration
Freedom From Biochemical and Clinical Failure
Time frame: From baseline to 5 years after registration
Freedom From Salvage Androgen Suppression Treatment
Time frame: From baseline to 5 years after registration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Thomas M. Pisansky, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing brachytherapy, hypofractionated radiation therapy and image-guided radiation therapy in people with Prostate Cancer, run by Mayo Clinic 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?
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 7 Aug 2019. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Sep 2018). 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?
Treatment Tolerance (Genitourinary [GU] or Gastrointestinal [GI] Adverse Events) (time frame: From baseline to 3 years after registration). 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 7 Aug 2019; AzTrials last refreshed its copy on 1 Nov 2026.