Clinical trial · Interventional
Pd-103 Dose De-Escalation for Early Stage Prostate Cancer: A Prospective Randomized Trial
NCT00247312CI-TRIAL-00019810completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasm | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pd-103 | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 125Gy prescription dose Pd-103
- description
- 125Gy prescription dose Pd-103
- interventionNames
- Radiation: Pd-103
- type
- ACTIVE_COMPARATOR
- label
- 110 Gy prescription dose Pd-103
- description
- 110 Gy prescription dose Pd-103
- interventionNames
- Radiation: Pd-103
Primary outcomes (2)
- measure
- PSA determinations will be obtained 3 months following implantation and then every 6 months.
- timeFrame
- every 6 months after inital PSA done at 3 months.
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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.
References
Publications (19)
- BACKGROUNDMerrick 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
- BACKGROUNDMerrick 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 14624895
- BACKGROUNDWallner 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
- BACKGROUNDStock 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 9588923
- BACKGROUNDStock 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 15062175
- BACKGROUNDKollmeier 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 14529768
- BACKGROUNDPotters 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.