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Internal Radiation Therapy With or Without External-Beam Radiation Therapy in Treating Patients With Localized Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00714753
Recruitment Status : Completed
First Posted : July 14, 2008
Results First Posted : September 12, 2018
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Radiation: brachytherapy
Radiation: hypofractionated radiation therapy
Radiation: image-guided radiation therapy
Radiation: intensity-modulated radiation therapy
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1 (HDR ± EBRT)
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 5
HDR Brachytherapy 5
External Beam Radiotherapy (EBRT) 1
Completed 5
Not Completed 0
Arm/Group Title Arm 1 (HDR ± EBRT)
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
All enrolled patients who were eligible and began treatment. Only 1 patient was registered to the HDR+EBRT arm. Due to protected health information, listing only 1 patient's results is contraindicated.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 5 participants
69.0
(65.0 to 72.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
0
   0.0%
Male
5
 100.0%
1.Primary Outcome
Title Treatment Tolerance (Genitourinary [GU] or Gastrointestinal [GI] Adverse Events)
Hide Description 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.
Time Frame From baseline to 3 years after registration
Hide Outcome Measure Data
Hide Analysis Population Description
All patients registered to a dose escalation Phase I group were analyzed for this endpoint. Only 1 patient was registered to the HDR+EBRT arm. Due to protected health information, listing only 1 patient's results is contraindicated.
Arm/Group Title Arm 1 (HDR ± EBRT)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: events
3
2.Secondary Outcome
Title Association Between Dose-volume Limitations for Organs at Risk and Rate and Severity of GU or GI Adverse Events
Hide Description 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.
Time Frame From baseline to 5 years after registration
Hide Outcome Measure Data
Hide Analysis Population Description
No patients registered to a dose escalation Phase I group were analyzed for this endpoint. With only 5 patients, the study team deemed that the information would be unsuitable.
Arm/Group Title Arm 1 (HDR ± EBRT)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Patient Preference for a Second Treatment (a Second High Dose-rate Brachytherapy Session or an External Beam Radiotherapy Session)
Hide Description 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.
Time Frame From baseline until the end of the first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
None of the enrolled patients were analyzed for this endpoint due to too few patients.
Arm/Group Title Arm 1 (HDR ± EBRT)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Changes in Health-related Quality of Life Scores
Hide Description 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.
Time Frame From baseline to 5 years after registration
Hide Outcome Measure Data
Hide Analysis Population Description
None of the enrolled patients were analyzed for this endpoint due to too few patients.
Arm/Group Title Arm 1 (HDR ± EBRT)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Freedom From Biochemical and Clinical Failure
Hide Description 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.
Time Frame From baseline to 5 years after registration
Hide Outcome Measure Data
Hide Analysis Population Description
With only 5 patients, the study team deemed that the information would be unsuitable.
Arm/Group Title Arm 1 (HDR ± EBRT)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Freedom From Salvage Androgen Suppression Treatment
Hide Description Estimates will be drawn from the Kaplan-Meier curves for the probability of freedom from salvage androgen suppression therapy.
Time Frame From baseline to 5 years after registration
Hide Outcome Measure Data
Hide Analysis Population Description
With only 5 patients, the study team deemed that this information would be unsuitable.
Arm/Group Title Arm 1 (HDR ± EBRT)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events were assessed within 7 days of High Dose-Rate Radiation (HDR) and External beam radiation therapy (EBRT), and at one month after completion of therapy, 6 months after registration, then every 6 months x 5 (through year 3), then every 12 months for years 4-5, then off study. Up to 5 years.
Adverse Event Reporting Description CTCAE term & grade: The descriptions & grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation & scientific analysis & is a single MedDRA Lowest Level Term (LLT). Only 1 patient was registered to the HDR+EBRT arm. Due to protected health information, listing only 1 patient's results is contraindicated.
 
Arm/Group Title Arm 1 (HDR ± EBRT)
Hide Arm/Group Description 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.
All-Cause Mortality
Arm 1 (HDR ± EBRT)
Affected / at Risk (%)
Total   0/5 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 (HDR ± EBRT)
Affected / at Risk (%) # Events
Total   0/5 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1 (HDR ± EBRT)
Affected / at Risk (%) # Events
Total   5/5 (100.00%)    
Gastrointestinal disorders   
Anal hemorrhage  1  1/5 (20.00%)  1
Diarrhea  1  5/5 (100.00%)  9
Flatulence  1  1/5 (20.00%)  1
General disorders   
Fatigue  1  1/5 (20.00%)  1
Infections and infestations   
Abdominal infection  1  1/5 (20.00%)  1
Bladder infection  1  1/5 (20.00%)  1
Renal and urinary disorders   
Bladder hemorrhage  1  2/5 (40.00%)  2
Bladder pain  1  1/5 (20.00%)  1
Bladder stenosis  1  1/5 (20.00%)  1
Cystitis  1  3/5 (60.00%)  3
Urethral hemorrhage  1  2/5 (40.00%)  2
Urethral pain  1  4/5 (80.00%)  6
Urinary frequency  1  4/5 (80.00%)  12
Urinary incontinence  1  3/5 (60.00%)  5
Urinary retention  1  3/5 (60.00%)  5
Urogenital disorder  1  1/5 (20.00%)  1
Reproductive system and breast disorders   
Erectile dysfunction  1  4/5 (80.00%)  5
Perineal pain  1  1/5 (20.00%)  1
Prostatic hemorrhage  1  2/5 (40.00%)  2
Prostatic pain  1  3/5 (60.00%)  3
1
Term from vocabulary, MedDRA 10
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Thomas M. Pisansky, M.D.
Organization: Mayo Clinic
EMail: Pisansky.Thomas@mayo.edu
Layout table for additonal information
Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00714753     History of Changes
Other Study ID Numbers: CDR0000600446
P30CA015083 ( U.S. NIH Grant/Contract )
MC0652 ( Other Identifier: Mayo Clinic Cancer Center )
08-001451 ( Other Identifier: Mayo Clinic IRB )
First Submitted: July 11, 2008
First Posted: July 14, 2008
Results First Submitted: May 3, 2018
Results First Posted: September 12, 2018
Last Update Posted: August 7, 2019