Clinical trial · Interventional
Radiotherapy for Oligometastatic Prostate Cancer
Phase II Stereotactic Body Radiotherapy (SBRT) and Stereotactic Hypofractionated Radiotherapy (SHRT) for Oligometastatic Prostate Cancer
NCT01859221CI-TRIAL-00060858completedN/AClinicalTrials.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 phase II study is to evaluate the outcomes of patients treated with an investigational radiation regimen using stereotactic radiotherapy for oligometastatic prostate cancer and to establish efficacy (producing a desired result or effect) and safety in this setting.
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 |
|---|---|---|---|
| Oligometastatic Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Castration Resistant
- description
- There are two different prognostic categories, hormones receptive and castration resistant, that have differing historical disease progression rates. We have therefore stratified the trial so that we can independently monitor the hypothesized improvement provided by radiation therapy in these two groups. Both groups will receive the same radiation modality which is interventional stereotactic radiation with two possible schedules of SBRT and SHRT.
- interventionNames
- Radiation: Stereotactic radiation
- type
- EXPERIMENTAL
- label
- Hormone Receptive
- description
- There are two different prognostic categories, hormones receptive and castration resistant, that have differing historical disease progression rates. We have therefore stratified the trial so that we can independently monitor the hypothesized improvement provided by radiation therapy in these two groups. Both groups will receive the same radiation modality which is interventional stereotactic radiation with two possible schedules of SBRT and SHRT.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with metastatic cancer of the prostate, * Patients may have received prior surgery, * Prior radiation therapy, androgen deprivation therapy (ADT), immunotherapy, bone metastasis directed therapy, or chemotherapy for prostate cancer. Exclusion Criteria: * End-stage heart disease, * End-stage liver disease, * End-stage renal disease, * End stage pulmonary disease * Current brain or central nervous system metastasis.
References
Publications (28)
- BACKGROUNDBrawley OW. Prostate cancer epidemiology in the United States. World J Urol. 2012 Apr;30(2):195-200. doi: 10.1007/s00345-012-0824-2. Epub 2012 Apr 5. PMID 22476558
- BACKGROUNDSiegel R, Naishadham D, Jemal A. Cancer statistics, 2012. CA Cancer J Clin. 2012 Jan-Feb;62(1):10-29. doi: 10.3322/caac.20138. Epub 2012 Jan 4. PMID 22237781
- BACKGROUNDHsiao W, Moses KA, Goodman M, Jani AB, Rossi PJ, Master VA. Stage IV prostate cancer: survival differences in clinical T4, nodal and metastatic disease. J Urol. 2010 Aug;184(2):512-8. doi: 10.1016/j.juro.2010.04.010. Epub 2010 Jun 17. PMID 20620410
- BACKGROUNDScosyrev E, Messing EM, Mohile S, Golijanin D, Wu G. Prostate cancer in the elderly: frequency of advanced disease at presentation and disease-specific mortality. Cancer. 2012 Jun 15;118(12):3062-70. doi: 10.1002/cncr.26392. Epub 2011 Oct 17. PMID 22006014
- BACKGROUNDJames ND, Sydes MR, Mason MD, Clarke NW, Anderson J, Dearnaley DP, Dwyer J, Jovic G, Ritchie AW, Russell JM, Sanders K, Thalmann GN, Bertelli G, Birtle AJ, O'Sullivan JM, Protheroe A, Sheehan D, Srihari N, Parmar MK; STAMPEDE investigators. Celecoxib plus hormone therapy versus hormone therapy alone for hormone-sensitive prostate cancer: first results from the STAMPEDE multiarm, multistage, randomised controlled trial. Lancet Oncol. 2012 May;13(5):549-58. doi: 10.1016/S1470-2045(12)70088-8. Epub 2012 Mar 26. PMID 22452894
- BACKGROUNDWidmark A, Klepp O, Solberg A, Damber JE, Angelsen A, Fransson P, Lund JA, Tasdemir I, Hoyer M, Wiklund F, Fossa SD; Scandinavian Prostate Cancer Group Study 7; Swedish Association for Urological Oncology 3. Endocrine treatment, with or without radiotherapy, in locally advanced prostate cancer (SPCG-7/SFUO-3): an open randomised phase III trial. Lancet. 2009 Jan 24;373(9660):301-8. doi: 10.1016/S0140-6736(08)61815-2. Epub 2008 Dec 16. PMID 19091394