A Phase 2 interventional study of brachytherapy and hypofractionated radiation therapy in Prostate Cancer, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to male participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2019-08-07.
Sponsored by Mayo Clinic · Phase 2, Interventional, and Treatment
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.
OBJECTIVES:
Primary
Secondary
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.
6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.
This study's enrollment of 5 is below the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Mayo Clinic is the lead sponsor of 3,263 studies on the registry; 670 are open to participants now.
Of its 450 completed or terminated interventional studies of FDA-regulated products, 318 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate, meeting one of the following criteria:
No pubic arch interference, as defined by either of the following:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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.
Radiation: brachytherapy · Radiation: hypofractionated radiation therapy · Radiation: image-guided radiation therapy · Radiation: intensity-modulated radiation therapy
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.
Time frame: From baseline to 3 years after registration
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.
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)
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
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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline to 5 years after registration
| Milestone | Arm 1 (HDR ± EBRT) |
|---|---|
| Started | 5 |
| Hdr brachytherapy | 5 |
| External beam radiotherapy (ebrt) | 1 |
| Completed | 5 |
| Not completed | 0 |
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.
| events | Arm 1 (HDR ± EBRT) |
|---|---|
| Treatment Tolerance (Genitourinary [GU] or Gastrointestinal [GI] Adverse Events) | 3 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Estimates will be drawn from the Kaplan-Meier curves for the probability of freedom from salvage androgen suppression therapy.
No measurements were reported for this outcome.
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1 (HDR ± EBRT) | 0/5 (0%) | 0/5 (0%) | 5/5 (100%) |
| Event | Arm 1 (HDR ± EBRT) |
|---|---|
| DiarrheaGastrointestinal disorders | 5/5 |
| Urethral painRenal and urinary disorders | 4/5 |
| Urinary frequencyRenal and urinary disorders | 4/5 |
| Erectile dysfunctionReproductive system and breast disorders | 4/5 |
| CystitisRenal and urinary disorders | 3/5 |
| Urinary incontinenceRenal and urinary disorders | 3/5 |
| Urinary retentionRenal and urinary disorders | 3/5 |
| Prostatic painReproductive system and breast disorders | 3/5 |
| Bladder hemorrhageRenal and urinary disorders | 2/5 |
| Urethral hemorrhageRenal and urinary disorders | 2/5 |
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(years) | Arm 1 (HDR ± EBRT) |
|---|---|
| Median | 69.0 (65.0 to 72.0) |
| Sex: Female, Male(Participants) | Arm 1 (HDR ± EBRT) |
|---|---|
| Female | 0 |
| Male | 5 |
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