NCT00247312

Brief Summary

The purpose of this study is to determine the most appropriate radiation implant dose for palladium-103 monotherapy. Radiation dose is related to potential cure. From previously published studies, it appears that the prescribed radiation dose can be reduced by 14-20% without any difference in potential cure (in this study, the dose is being decreased 10%). Although most patients tolerate brachytherapy well, complications to appear to be related to radiation exposure to normal structures (i.e. urethra, rectum and proximal penis). By reducing the prescribed dose, it is conceivable that fewer patients will experience side effects and complications.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
319

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2005

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 1, 2005

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

November 17, 2015

Status Verified

November 1, 2015

Enrollment Period

10.1 years

First QC Date

October 28, 2005

Last Update Submit

November 16, 2015

Conditions

Prostatic Neoplasm

Keywords

Prostate cancerbrachytherapypalladium 103I-125

Outcome Measures

Primary Outcomes (2)

  • PSA determinations will be obtained 3 months following implantation and then every 6 months.

    PSA determinations will be obtained 3 months following implantation and then every 6 months.

    every 6 months after inital PSA done at 3 months.

  • Androgen deprivation therapy will not be initiated unless the PSA exceeds 10 ng/mL or distant metastases are detected.

    Androgen deprivation therapy will not be initiated unless the PSA exceeds 10 ng/mL or distant metastases are detected.

    depends on outcome

Secondary Outcomes (4)

  • Following brachytherapy, I-PSS will be obtained on months 1, 3, 6, 12, 18, 24, 36, 48, 60.

    months 1, 3, 6, 12, 18, 24, 36, 48, 60.

  • Following brachytherapy, R-FAS will be obtained on months 12, 36 and 60.

    months 12, 36 and 60.

  • Following brachytherapy, IIEF will be obtained on months 12, 36 and 60.

    months 12, 36 and 60.

  • Post implant quality of life evaluations will be forwarded to Dr. G. Merrick as appropriate.

    as needed

Study Arms (2)

125Gy prescription dose Pd-103

ACTIVE COMPARATOR

125Gy prescription dose Pd-103

Radiation: Pd-103

110 Gy prescription dose Pd-103

ACTIVE COMPARATOR

110 Gy prescription dose Pd-103

Radiation: Pd-103

Interventions

Pd-103RADIATION
110 Gy prescription dose Pd-103125Gy prescription dose Pd-103

Eligibility Criteria

Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Low risk patients: Gleason score less than or equal to 6, PSA less than or equal to 10 ng/mL and clinical stage T1b-T2b (2002 AJCC.
  • An enzymatic prostatic acid phosphatase must be obtained prior to implantation.
  • No pelvic external beam radiation therapy for either prostate cancer or other malignancies.
  • Androgen deprivation therapy less than 4 month duration for size reduction is allowable.
  • No surgical staging for prostate cancer.
  • A minimum of 5 year life expectancy.
  • No other invasive cancer diagnosis other than non-melanoma skin cancer within the last 5 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Radiation Oncology 174 Department of Veterans Affairs

Seattle, Washington, 98108-1597, United States

Location

Schiffler Cancer Center

Wheeling, West Virginia, 26003, United States

Location

Related Publications (19)

  • Merrick GS, Wallner KE, Butler WM. Permanent interstitial brachytherapy for the management of carcinoma of the prostate gland. J Urol. 2003 May;169(5):1643-52. doi: 10.1097/01.ju.0000035544.25483.61.

    PMID: 12686802BACKGROUND

  • Merrick GS, Wallner KE, Butler WM. Minimizing prostate brachytherapy-related morbidity. Urology. 2003 Nov;62(5):786-92. doi: 10.1016/s0090-4295(03)00558-2. No abstract available.

    PMID: 14624895BACKGROUND

  • Wallner K, Merrick G, True L, Sutlief S, Cavanagh W, Butler W. 125I versus 103Pd for low-risk prostate cancer: preliminary PSA outcomes from a prospective randomized multicenter trial. Int J Radiat Oncol Biol Phys. 2003 Dec 1;57(5):1297-303. doi: 10.1016/s0360-3016(03)01448-2.

    PMID: 14630265BACKGROUND

  • Stock RG, Stone NN, Tabert A, Iannuzzi C, DeWyngaert JK. A dose-response study for I-125 prostate implants. Int J Radiat Oncol Biol Phys. 1998 Apr 1;41(1):101-8. doi: 10.1016/s0360-3016(98)00006-6.

    PMID: 9588923BACKGROUND

  • Stock RG, Stone NN, Dahlal M, Lo YC. What is the optimal dose for 125I prostate implants? A dose-response analysis of biochemical control, posttreatment prostate biopsies, and long-term urinary symptoms. Brachytherapy. 2002;1(2):83-9. doi: 10.1016/s1538-4721(02)00017-x.

    PMID: 15062175BACKGROUND

  • Kollmeier MA, Stock RG, Stone N. Biochemical outcomes after prostate brachytherapy with 5-year minimal follow-up: importance of patient selection and implant quality. Int J Radiat Oncol Biol Phys. 2003 Nov 1;57(3):645-53. doi: 10.1016/s0360-3016(03)00627-8.

    PMID: 14529768BACKGROUND

  • Potters L, Cao Y, Calugaru E, Torre T, Fearn P, Wang XH. A comprehensive review of CT-based dosimetry parameters and biochemical control in patients treated with permanent prostate brachytherapy. Int J Radiat Oncol Biol Phys. 2001 Jul 1;50(3):605-14. doi: 10.1016/s0360-3016(01)01473-0.

    PMID: 11395226BACKGROUND

  • Merrick GS, Butler WM. Modified uniform seed loading for prostate brachytherapy: rationale, design, and evaluation. Tech Urol. 2000 Jun;6(2):78-84.

    PMID: 10798804BACKGROUND

  • Merrick GS, Butler WM, Dorsey AT, Lief JH. Potential role of various dosimetric quality indicators in prostate brachytherapy. Int J Radiat Oncol Biol Phys. 1999 Jun 1;44(3):717-24. doi: 10.1016/s0360-3016(99)00067-x.

    PMID: 10348304BACKGROUND

  • Merrick GS, Butler WM, Dorsey AT, Lief JH. Effect of prostate size and isotope selection on dosimetric quality following permanent seed implantation. Tech Urol. 2001 Sep;7(3):233-40.

    PMID: 11575521BACKGROUND

  • Merrick GS, Butler WM, Dorsey AT, Lief JH, Totterd, Coram RJ. Influence of prophylactic dexamethasone on edema following prostate brachytherapy. Tech Urol. 2000 Jun;6(2):117-22.

    PMID: 10798812BACKGROUND

  • Merrick GS, Butler WM, Wallner KE, Galbreath RW, Adamovich E. Permanent interstitial brachytherapy in younger patients with clinically organ-confined prostate cancer. Urology. 2004 Oct;64(4):754-9. doi: 10.1016/j.urology.2004.04.054.

    PMID: 15491715BACKGROUND

  • Merrick GS, Butler WM, Wallner KE, Galbreath RW, Lief JH. Long-term urinary quality of life after permanent prostate brachytherapy. Int J Radiat Oncol Biol Phys. 2003 Jun 1;56(2):454-61. doi: 10.1016/s0360-3016(02)04600-x.

    PMID: 12738320BACKGROUND

  • Merrick GS, Butler WM, Tollenaar BG, Galbreath RW, Lief JH. The dosimetry of prostate brachytherapy-induced urethral strictures. Int J Radiat Oncol Biol Phys. 2002 Feb 1;52(2):461-8. doi: 10.1016/s0360-3016(01)01811-9.

    PMID: 11872293BACKGROUND

  • Merrick GS, Butler WM, Wallner KE, Lief JH, Anderson RL, Smeiles BJ, Galbreath RW, Benson ML. The importance of radiation doses to the penile bulb vs. crura in the development of postbrachytherapy erectile dysfunction. Int J Radiat Oncol Biol Phys. 2002 Nov 15;54(4):1055-62. doi: 10.1016/s0360-3016(02)03031-6.

    PMID: 12419431BACKGROUND

  • Herrmann RG, Bohnert HJ, Kowallik KV, Schmitt JM. Size, conformation and purity of chloroplast DNA of some higher plants. Biochim Biophys Acta. 1975 Jan 20;378(2):305-17. doi: 10.1016/0005-2787(75)90118-5.

    PMID: 1092350BACKGROUND

  • Snyder KM, Stock RG, Hong SM, Lo YC, Stone NN. Defining the risk of developing grade 2 proctitis following 125I prostate brachytherapy using a rectal dose-volume histogram analysis. Int J Radiat Oncol Biol Phys. 2001 Jun 1;50(2):335-41. doi: 10.1016/s0360-3016(01)01442-0.

    PMID: 11380219BACKGROUND

  • Merrick GS, Butler WM, Wallner KE, Hines AL, Allen Z. Late rectal function after prostate brachytherapy. Int J Radiat Oncol Biol Phys. 2003 Sep 1;57(1):42-8. doi: 10.1016/s0360-3016(03)00501-7.

    PMID: 12909214BACKGROUND

  • Consensus statement: guidelines for PSA following radiation therapy. American Society for Therapeutic Radiology and Oncology Consensus Panel. Int J Radiat Oncol Biol Phys. 1997 Mar 15;37(5):1035-41. No abstract available.

    PMID: 9169810BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Palladium-103

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Gregory S. Merrick, MD

    Schiffler Cancer Center, Wheeling, WV

    PRINCIPAL INVESTIGATOR

  • Kent E. Wallner, MD

    Department of Veterans Affairs, Seattle, WA

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director

Study Record Dates

First Submitted

October 28, 2005

First Posted

November 1, 2005

Study Start

October 1, 2005

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

November 17, 2015

Record last verified: 2015-11

Locations

US(2)