Prostatic Neoplasm Clinical Trial
Official title:
Pd-103 Dose De-Escalation for Early Stage Prostate Cancer: A Prospective Randomized Trial
Verified date | November 2015 |
Source | Schiffler Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 319 |
Est. completion date | November 2015 |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - Exclusion criteria will be limited to patients who do not meet the above eligibility criteria. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United States | Radiation Oncology 174 Department of Veterans Affairs | Seattle | Washington |
United States | Schiffler Cancer Center | Wheeling | West Virginia |
Lead Sponsor | Collaborator |
---|---|
Schiffler Cancer Center |
United States,
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. — View Citation
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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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Merrick GS, Butler WM. Modified uniform seed loading for prostate brachytherapy: rationale, design, and evaluation. Tech Urol. 2000 Jun;6(2):78-84. Review. — View Citation
Merrick GS, Wallner KE, Butler WM. Minimizing prostate brachytherapy-related morbidity. Urology. 2003 Nov;62(5):786-92. Review. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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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. — View Citation
* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | No |
Primary | 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 | No |
Secondary | Following brachytherapy, I-PSS will be obtained on months 1, 3, 6, 12, 18, 24, 36, 48, 60. | 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. | No |
Secondary | Following brachytherapy, R-FAS will be obtained on months 12, 36 and 60. | Following brachytherapy, R-FAS will be obtained on months 12, 36 and 60. | months 12, 36 and 60. | No |
Secondary | Following brachytherapy, IIEF will be obtained on months 12, 36 and 60. | Following brachytherapy, IIEF will be obtained on months 12, 36 and 60. | months 12, 36 and 60. | No |
Secondary | Post implant quality of life evaluations will be forwarded to Dr. G. Merrick as appropriate. | Post implant quality of life evaluations will be forwarded to Dr. G. Merrick as appropriate. | as needed | No |
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