search
Back to results

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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
brachytherapy
hypofractionated radiation therapy
image-guided radiation therapy
intensity-modulated radiation therapy
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring stage I prostate cancer, stage II prostate cancer, adenocarcinoma of the prostate

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Group

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
July 11, 2008
Last Updated
July 24, 2019
Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00714753
Brief Title
Internal Radiation Therapy With or Without External-Beam Radiation Therapy in Treating Patients With Localized Prostate Cancer
Official Title
Pilot Evaluation of High Dose-Rate Brachytherapy ± Image-Guided Intensity Modulated Hypofractionated External Radiotherapy for Localized Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
stage I prostate cancer, stage II prostate cancer, adenocarcinoma of the prostate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm 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.
Intervention Type
Radiation
Intervention Name(s)
brachytherapy
Intervention Type
Radiation
Intervention Name(s)
hypofractionated radiation therapy
Intervention Type
Radiation
Intervention Name(s)
image-guided radiation therapy
Intervention Type
Radiation
Intervention Name(s)
intensity-modulated radiation therapy
Primary Outcome Measure Information:
Title
Treatment Tolerance (Genitourinary [GU] or Gastrointestinal [GI] Adverse Events)
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
Secondary Outcome Measure Information:
Title
Association Between Dose-volume Limitations for Organs at Risk and Rate and Severity of GU or GI Adverse Events
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
Title
Patient Preference for a Second Treatment (a Second High Dose-rate Brachytherapy Session or an External Beam Radiotherapy Session)
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
Title
Changes in Health-related Quality of Life Scores
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
Title
Freedom From Biochemical and Clinical Failure
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
Title
Freedom From Salvage Androgen Suppression Treatment
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas M. Pisansky, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs