Low Dose Supplemental External Radiation With Pd-103 Versus Pd-103 Alone for Prostate Cancer

NCT00241384 | Completed Phase 3 DMC

• 1 other identifier: 04-8-10
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 2

Brief Summary

The primary purpose of this study is to evaluate two treatment regimens for prostate cancer, prostate implant with 20 Gy of external beam radiation therapy versus prostate implant with 0 Gy of external beam radiation therapy. Patients diagnosed with intermediate risk prostate cancer between the ages of 40 and 80 who have chosen brachytherapy with or without external beam radiation therapy as their intended treatment will be eligible and will be offered participation.

Conditions

Prostate Cancer

Keywords

Prostatic Cancer; Brachytherapy; Prostatic neoplasm; Radiation therapy

Outcome Measures

Primary Outcomes (3)

• Serial PSA : 6, 12, 18 and 24 months and then yearly.

  Serial PSA : 6, 12, 18 and 24 months and then yearly.

  6, 12, 18 and 24 months and then yearly

• Post treatment biopsies in those with persistently elevated

  Post treatment biopsies in those with persistently elevated

  as needed

• PSA which is suggestive of residual tumor.

  PSA which is suggestive of residual tumor.

  as needed

Study Arms (2)

Pd-103 with 20Gy External Beam

ACTIVE COMPARATOR

Pd-103 with 20Gy External Beam

Procedure: External beam radiation

Pd-103 alone

ACTIVE COMPARATOR

Pd-103 alone

Procedure: Pd-103

Interventions

External beam radiation PROCEDURE

Pd-103 with 20Gy External Beam

Pd-103 PROCEDURE

Pd-103 alone

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with previously untreated prostatic cancer.
• Must have PSA 10-20 ng/ml, Gleason 7 to 9

You may not qualify if:

• Patients with proven regional lymph node involvement will be excluded.

Sponsors & Collaborators

• Schiffler Cancer Center: lead
• Theragenics: collaborator
• University of Washington: collaborator

Study Sites (2)

Veterans Administration Puget Sound Health Care System

Seattle, Washington, 98108-1597, United States

Location

Schiffler Cancer Center

Wheeling, West Virginia, 26003, United States

Location

Related Publications (10)

• Bartolini R, Dattoli G, Giannessi L, Mezi L, Renieri A, Migliorati M, Bruni C, Couprie ME, Garzella D, Orlandi G. Saturation and electron-beam lifetime in a storage ring free-electron laser. Phys Rev E Stat Nonlin Soft Matter Phys. 2004 Mar;69(3 Pt 2):036501. doi: 10.1103/PhysRevE.69.036501. Epub 2004 Mar 4.

  PMID: 15089421 BACKGROUND

• Blasko JC, Grimm PD, Sylvester JE, Badiozamani KR, Hoak D, Cavanagh W. Palladium-103 brachytherapy for prostate carcinoma. Int J Radiat Oncol Biol Phys. 2000 Mar 1;46(4):839-50. doi: 10.1016/s0360-3016(99)00499-x.

  PMID: 10705004 BACKGROUND

• Critz FA, Williams WH, Levinson AK, Benton JB, Holladay CT, Schnell FJ Jr. Simultaneous irradiation for prostate cancer: intermediate results with modern techniques. J Urol. 2000 Sep;164(3 Pt 1):738-41; discussion 741-3. doi: 10.1097/00005392-200009010-00028.

  PMID: 10953137 BACKGROUND

• Merrick GS, Butler WM, Galbreath RW, Lief JH. Five-year biochemical outcome following permanent interstitial brachytherapy for clinical T1-T3 prostate cancer. Int J Radiat Oncol Biol Phys. 2001 Sep 1;51(1):41-8. doi: 10.1016/s0360-3016(01)01594-2.

  PMID: 11516849 BACKGROUND

• Blue E. Letting go of Ben. Nurs Spectr (Wash D C). 1999 Mar 8;9(5):20. No abstract available.

  PMID: 10562177 BACKGROUND

• 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: 11395226 BACKGROUND

• Blasko JC, Ragde H, Schumacher D. Transperineal percutaneous iodine-125 implantatio for prostatic carcinoma using transrectal ultrasound and template guidance. Endo/Hypertherm 1987;3:131-39.

  BACKGROUND

• Wallner K, Merrick G, Butler W, Sheretz T, Sutlief S, Cavanagh W, et al. 20 Gy versus 44 Gy supplemental beam radiation combined with Pd-103 prostate brachytherapy: early results from a prospective randomized multicenter trial (submitted)2004.

  BACKGROUND

• Prestidge BR, Hoak DC, Grimm PD, Ragde H, Cavanagh W, Blasko JC. Posttreatment biopsy results following interstitial brachytherapy in early-stage prostate cancer. Int J Radiat Oncol Biol Phys. 1997 Jan 1;37(1):31-9. doi: 10.1016/s0360-3016(96)00390-2.

  PMID: 9054874 BACKGROUND

• Zietman AL, Tibbs MK, Dallow KC, Smith CT, Althausen AF, Zlotecki RA, Shipley WU. Use of PSA nadir to predict subsequent biochemical outcome following external beam radiation therapy for T1-2 adenocarcinoma of the prostate. Radiother Oncol. 1996 Aug;40(2):159-62. doi: 10.1016/0167-8140(96)01770-7.

  PMID: 8884970 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Palladium-103

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Gregory S Merrick, MD

  Schiffler Cancer Center, Wheeling, WV

  PRINCIPAL INVESTIGATOR

• Kent E Wallner, MD

  University of Washington VA Center

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: October 14, 2005
• First Posted: October 18, 2005
• Study Start: January 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)