Implant and External Radiation for Prostate Cancer With or Without Hormonal Therapy: A Prospective Randomized Trial

NCT00243646 | Terminated Phase 3 DMC

• 1 other identifier: 05-8-4
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 3

Brief Summary

Determine the role of androgen deprivation therapy in high risk patients receiving 45 Gy of pelvic radiotherapy plus a Pd-103 boost and the impact of the duration of ADT in hormonally-manipulated patients.

Conditions

Prostate Cancer

Keywords

Radiation therapy; Brachytherapy; Prostatic neoplasm

Outcome Measures

Primary Outcomes (3)

• PSA 3 and 6 months following implantation then every 6 months.

  PSA 3 and 6 months following implantation then every 6 months.

  3 and 6 months following implantation then every 6 months

• Serum testosterone levels at 3 and 6 months in hormonally manipulated patients.

  Serum testosterone levels at 3 and 6 months in hormonally manipulated patients

  3 and 6 months

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

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

  as needed

Secondary Outcomes (3)

• EPIC on 6 and 12 months and then annually.

  6 and 12 months and then annually.

• Hormonally manipulated patients will obtain a DEXA scan.

  as needed

• For documented osteoporosis, Zometa (4 mg IV over 15 minutes) every 3 months is recommended.

  every 3 months is recommended.

Study Arms (2)

no hormones

ACTIVE COMPARATOR

All patients will receive a 5-week course of external beam radiation therapy to the pelvis and a Pd-103 brachytherapy implant with no hormones

Radiation: External beam radiation

9 months of hormone therapy

ACTIVE COMPARATOR

All patients will receive a 5-week course of external beam radiation therapy to the pelvis and a Pd-103 brachytherapy implant with a 9 month course of hormone therapy

Radiation: External beam radiation; Drug: Lupron; Drug: Casodex

Interventions

External beam radiation RADIATION

All patients will receive a 5-week course of external beam radiation therapy to the pelvis and a Pd-103 brachytherapy implant

9 months of hormone therapy; no hormones

Lupron DRUG

9 months of an LHRH agonist and 4 months of an anti-androgen) is optimal for securing long-term biochemical control (a stable, non-rising PSA).

9 months of hormone therapy

Casodex DRUG

9 months of an LHRH agonist and 4 months of an anti-androgen) is optimal for securing long-term biochemical control (a stable, non-rising PSA).

9 months of hormone therapy

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• High risk patients - Two to three of the following: PSA 10-30 ng/mL, Gleason score greater than or equal to 6, clinical stage greater than or equal to T2c (2002 ACJJ).
• CT of the abdomen and pelvis and bone scan without evidence of metastases.
• An enzymatic prostatic acid phosphatase must be obtained prior to randomization.
• A serum testosterone must be obtained prior to initiation of androgen deprivation therapy.
• No prior pelvic external beam radiation therapy for prostate cancer or other malignancies.
• No prior androgen deprivation therapy.
• Minimum 5 year life expectancy.
• No other invasive cancer diagnosis other than non-melanoma skin cancer within the last 5 years.

Sponsors & Collaborators

• Schiffler Cancer Center: lead
• Kent E. Wallner, M.D.: collaborator
• Sylvester, John, M.D.: collaborator

Study Sites (3)

Seattle Prostate Institute

Seattle, Washington, 98104, United States

Location

Groupe Health Cooperative, Veterans Adminstration Hospital and University of Washington

Seattle, Washington, 98108, United States

Location

Schiffler Cancer Center

Wheeling, West Virginia, 26003, United States

Location

Related Publications (15)

• 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: 12686802 BACKGROUND

• Bolla M, Collette L, Blank L, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C, Mattelaer J, Lopez Torecilla J, Pfeffer JR, Lino Cutajar C, Zurlo A, Pierart M. Long-term results with immediate androgen suppression and external irradiation in patients with locally advanced prostate cancer (an EORTC study): a phase III randomised trial. Lancet. 2002 Jul 13;360(9327):103-6. doi: 10.1016/s0140-6736(02)09408-4.

  PMID: 12126818 BACKGROUND

• Pilepich MV, Caplan R, Byhardt RW, Lawton CA, Gallagher MJ, Mesic JB, Hanks GE, Coughlin CT, Porter A, Shipley WU, Grignon D. Phase III trial of androgen suppression using goserelin in unfavorable-prognosis carcinoma of the prostate treated with definitive radiotherapy: report of Radiation Therapy Oncology Group Protocol 85-31. J Clin Oncol. 1997 Mar;15(3):1013-21. doi: 10.1200/JCO.1997.15.3.1013.

  PMID: 9060541 BACKGROUND

• Roach M 3rd, DeSilvio M, Lawton C, Uhl V, Machtay M, Seider MJ, Rotman M, Jones C, Asbell SO, Valicenti RK, Han S, Thomas CR Jr, Shipley WS; Radiation Therapy Oncology Group 9413. Phase III trial comparing whole-pelvic versus prostate-only radiotherapy and neoadjuvant versus adjuvant combined androgen suppression: Radiation Therapy Oncology Group 9413. J Clin Oncol. 2003 May 15;21(10):1904-11. doi: 10.1200/JCO.2003.05.004.

  PMID: 12743142 BACKGROUND

• D'Amico AV, Manola J, Loffredo M, Renshaw AA, DellaCroce A, Kantoff PW. 6-month androgen suppression plus radiation therapy vs radiation therapy alone for patients with clinically localized prostate cancer: a randomized controlled trial. JAMA. 2004 Aug 18;292(7):821-7. doi: 10.1001/jama.292.7.821.

  PMID: 15315996 BACKGROUND

• Crook J, Ludgate C, Malone S, Lim J, Perry G, Eapen L, Bowen J, Robertson S, Lockwood G. Report of a multicenter Canadian phase III randomized trial of 3 months vs. 8 months neoadjuvant androgen deprivation before standard-dose radiotherapy for clinically localized prostate cancer. Int J Radiat Oncol Biol Phys. 2004 Sep 1;60(1):15-23. doi: 10.1016/j.ijrobp.2004.02.022.

  PMID: 15337535 BACKGROUND

• Merrick GS, Butler WM, Galbreath RW, Lief JH, Adamovich E. Does hormonal manipulation in conjunction with permanent interstitial brachytherapy, with or without supplemental external beam irradiation, improve the biochemical outcome for men with intermediate or high-risk prostate cancer? BJU Int. 2003 Jan;91(1):23-9. doi: 10.1046/j.1464-410x.2003.04024.x.

  PMID: 12614244 BACKGROUND

• Merrick GS, Butler WM, Wallner KE, Galbreath RW, Lief JH, Allen Z, Adamovich E. Impact of supplemental external beam radiotherapy and/or androgen deprivation therapy on biochemical outcome after permanent prostate brachytherapy. Int J Radiat Oncol Biol Phys. 2005 Jan 1;61(1):32-43. doi: 10.1016/j.ijrobp.2004.05.003.

  PMID: 15629591 BACKGROUND

• Lee LN, Stock RG, Stone NN. Role of hormonal therapy in the management of intermediate- to high-risk prostate cancer treated with permanent radioactive seed implantation. Int J Radiat Oncol Biol Phys. 2002 Feb 1;52(2):444-52. doi: 10.1016/s0360-3016(01)02598-6.

  PMID: 11872291 BACKGROUND

• Stock RG, Cahlon O, Cesaretti JA, Kollmeier MA, Stone NN. Combined modality treatment in the management of high-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2004 Aug 1;59(5):1352-9. doi: 10.1016/j.ijrobp.2004.01.023.

  PMID: 15275720 BACKGROUND

• Sylvester J, Blasko JC, Grimm PD, Meier R, Goy B, Colburn G, Cavanagh W. Neoadjuvant Androgen Ablation Combined with External-Beam Radiation Therapy and Permanent Interstitial Brachytherapy Boost in Localized Prostate Cancer. Mol Urol. 1999;3(3):231-236.

  PMID: 10851328 BACKGROUND

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

  PMID: 10798804 BACKGROUND

• 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: 9169810 BACKGROUND

• 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: 14630265 BACKGROUND

• Wei JT, Dunn RL, Litwin MS, Sandler HM, Sanda MG. Development and validation of the expanded prostate cancer index composite (EPIC) for comprehensive assessment of health-related quality of life in men with prostate cancer. Urology. 2000 Dec 20;56(6):899-905. doi: 10.1016/s0090-4295(00)00858-x.

  PMID: 11113727 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Leuprolide; bicalutamide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Gregory S Merrick, MD

  Schiffler Cancer Center, Wheeling, WV

  PRINCIPAL INVESTIGATOR

• Kent E. Wallner, MD

  Group Health Cooperative, Veterans Administration Hospital, and University of Washington

  STUDY CHAIR

• John Sylvester, MD

  Seattle Prostate Institute Seattle, WA 98104

  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 20, 2005
• First Posted: October 24, 2005
• Study Start: August 1, 2004
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: April 14, 2016

Record last verified: 2016-04

Locations

US (3)