Clinical trial · Interventional
High-Dose Rate Brachytherapy and Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer
Phase I Trial of High Dose Rate Brachytherapy Combined With Stereotactic Body Radiation Therapy for Intermediate Risk Prostate Cancer Patients
NCT01655836CI-TRIAL-00094971active not recruitingPhase 1ClinicalTrials.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 first technology is called high dose rate brachytherapy. Brachytherapy is sometimes called internal radiation therapy. High dose rate brachytherapy is a procedure that involves temporarily placing radioactive material inside the patient's body for about 10-20 minutes. Then, the remainder of the radiation treatment will be given over a 3 week period using stereotactic body radiation therapy (SBRT). SBRT is a novel treatment modality that involves the delivery of very high individual doses of radiation to tumors with high precision. This allows the doctor to deliver the same amount of radiation in a much shorter time. The purpose of this study is to determine the safety of brachytherapy when combined with hypofractionated SBRT.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Prostate | Prostate Adenocarcinoma | ALIAS | 0.90 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Recurrent Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brachytherapy | Radiation | — | UNRESOLVED |
| Quality-of-life assessment | Procedure | — | UNRESOLVED |
| Questionnaire administration | Other | — | UNRESOLVED |
| Stereotactic Body Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (HDR brachytherapy, SBRT)
- description
- Patients undergo HDR brachytherapy on day 0 followed by SBRT on days 15-30
- interventionNames
- Radiation: Brachytherapy
- Radiation: Stereotactic Body Radiation Therapy
- Procedure: Quality-of-life assessment
- Other: Questionnaire administration
Primary outcomes (1)
- measure
- Dose limiting toxicities (DLT) graded according to the National Cancer Institute, Common Toxicity Criteria (NCI, CTC), v 4.0
- timeFrame
- Up to 3 months
- description
- Data analysis of phase I studies is descriptive. All estimates of dose-specific rates (e.g., response and toxicity) will be presented with corresponding confidence intervals using the exact method.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adenocarcinoma of the prostate with intermediate risk disease T2b-T2c or Gleason score 7 or prostate specific antigen (PSA) 10-20 ng/ml, without metastatic disease * To rule out metastatic disease, patients must have the following tests: * Bone scan within 60 days prior to registration * Computed tomography (CT) of abdomen/pelvis within 60 days prior to registration * Karnofsky performance status \> 70 * Age \> 18 * PSA blood test within 60 days prior to registration * Prostate biopsy within 180 days prior to registration * Within 60 days prior to registration, hematologic minimal values: * Absolute neutrophil count \> 1,500/mm\^3 * Hemoglobin \> 8.0 g/dl * Platelet count \> 100,000/mm\^3 * Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter * No history of previous pelvic irradiation Exclusion Criteria: * History of urological surgery or procedures predisposing to GU complications after radiation, i.e., anastomoses, stricture repair, etc. (will be determined by radiation oncologist) * History of prior pelvic irradiation * Documented distant metastatic disease * Prior radical prostatectomy or cryosurgery for prostate cancer
References
Publications (26)
- BACKGROUNDAdkison JB, McHaffie DR, Bentzen SM, Patel RR, Khuntia D, Petereit DG, Hong TS, Tome W, Ritter MA. Phase I trial of pelvic nodal dose escalation with hypofractionated IMRT for high-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2012 Jan 1;82(1):184-90. doi: 10.1016/j.ijrobp.2010.09.018. Epub 2010 Dec 14. PMID 21163590
- BACKGROUNDAl-Mamgani A, van Putten WL, Heemsbergen WD, van Leenders GJ, Slot A, Dielwart MF, Incrocci L, Lebesque JV. Update of Dutch multicenter dose-escalation trial of radiotherapy for localized prostate cancer. Int J Radiat Oncol Biol Phys. 2008 Nov 15;72(4):980-8. doi: 10.1016/j.ijrobp.2008.02.073. Epub 2008 May 19. PMID 18495377
- BACKGROUNDBoike TP, Lotan Y, Cho LC, Brindle J, DeRose P, Xie XJ, Yan J, Foster R, Pistenmaa D, Perkins A, Cooley S, Timmerman R. Phase I dose-escalation study of stereotactic body radiation therapy for low- and intermediate-risk prostate cancer. J Clin Oncol. 2011 May 20;29(15):2020-6. doi: 10.1200/JCO.2010.31.4377. Epub 2011 Apr 4. PMID 21464418
- BACKGROUNDBrenner DJ, Martinez AA, Edmundson GK, Mitchell C, Thames HD, Armour EP. Direct evidence that prostate tumors show high sensitivity to fractionation (low alpha/beta ratio), similar to late-responding normal tissue. Int J Radiat Oncol Biol Phys. 2002 Jan 1;52(1):6-13. doi: 10.1016/s0360-3016(01)02664-5. PMID 11777617
- BACKGROUNDD'Amico AV, Whittington R, Malkowicz SB, Schultz D, Blank K, Broderick GA, Tomaszewski JE, Renshaw AA, Kaplan I, Beard CJ, Wein A. Biochemical outcome after radical prostatectomy, external beam radiation therapy, or interstitial radiation therapy for clinically localized prostate cancer. JAMA. 1998 Sep 16;280(11):969-74. doi: 10.1001/jama.280.11.969. PMID 9749478
- BACKGROUNDDearnaley DP, Sydes MR, Graham JD, Aird EG, Bottomley D, Cowan RA, Huddart RA, Jose CC, Matthews JH, Millar J, Moore AR, Morgan RC, Russell JM, Scrase CD, Stephens RJ, Syndikus I, Parmar MK; RT01 collaborators. Escalated-dose versus standard-dose conformal radiotherapy in prostate cancer: first results from the MRC RT01 randomised controlled trial. Lancet Oncol. 2007 Jun;8(6):475-87. doi: 10.1016/S1470-2045(07)70143-2.