Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
12 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-11-07
Study Completion Date
2027-12-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
It is a phase I study of radical hypofractionation delivering one single fraction of SBRT in patients with low- and favorable intermediate-risk prostate cancer that will undergo placement of the SpaceOAR hydrogel prior to treatment.
Our hypothesis is that treatments can be safely delivered in one single fraction using SBRT provided the separation between the prostate and rectum is increased using the hydrogel
Our hypothesis is that treatments can be safely delivered in one single fraction using SBRT provided the separation between the prostate and rectum is increased using the hydrogel
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Two Fraction Prostate SBRT With DIL SIB
NCT05864196
Prostate Cancer
RECRUITING
PHASE1
Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer
NCT01540994
Prostatic Neoplasm
COMPLETED
NA
Stereotactic Body Radiotherapy (SBRT) With Concurrent Boost for Low- and Intermediate-Risk Prostate Cancer
NCT01409473
Prostate Cancer
WITHDRAWN
PHASE2
Radical Radiotherapy by External Beam Radiation Versus Radical Radiotherapy With Temporary Iridium Implant Plus External Beam Radiation in Carcinoma of the Prostate
NCT00548600
Prostate Cancer
COMPLETED
PHASE3
Focal Therapy With Stereotactic Body Radiation Therapy (SBRT) for Patients With a Single Prostate Tumor
NCT05616650
Prostatic Neoplasms
Prostate Cancer
Prostate Adenocarcinoma
RECRUITING
PHASE2
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
There is a pre-treatment visit to the radiation oncology department. A gel is injected between the prostate and the rectum. This procedure is done with the use of a transrectal ultrasound, similarly to the prostate biopsy the patient had. A local anesthetic will be applied to numb the skin and to the underneath tissue where the injection will be performed. The procedure itself will take approximately 20 minutes and after a short observation time, the patient returns home.
The next visit (approximately after 7 days after the insertion of the gel), a CT scan and MRI-scan will be done. Prior to the scans, a urinary catheter will be inserted in the bladder through the penis, and removed once the scans are done. Using these images, the doctor and the team involved will perform an individualized planning study to establish the safest way the radiation will enter your body. When the treatment plan is ready, patient is called to receive the single treatment.
A urinary catheter again will be inserted in the bladder and the patient will be directed to the room where your treatment will be delivered. The treatment should last approximately 30 minutes. After the treatment, the urinary catheter will be removed.
The next visit (approximately after 7 days after the insertion of the gel), a CT scan and MRI-scan will be done. Prior to the scans, a urinary catheter will be inserted in the bladder through the penis, and removed once the scans are done. Using these images, the doctor and the team involved will perform an individualized planning study to establish the safest way the radiation will enter your body. When the treatment plan is ready, patient is called to receive the single treatment.
A urinary catheter again will be inserted in the bladder and the patient will be directed to the room where your treatment will be delivered. The treatment should last approximately 30 minutes. After the treatment, the urinary catheter will be removed.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Prostate Cancer
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Single Fraction SBRT in the treatment of prostate cancer
Prior to treatment, a hydrogel spacer will be inserted between the recutm and prostate. A urinary catheter will also be inserted in the bladder. A single dose of 19Gy will be delivered with an IMRT technique. The treatment should last approximately 30 minutes. After the treatment, the urinary catheter will be removed.
Group Type
EXPERIMENTAL
Stereotactic Body Radiation Therapy (SBRT)
Intervention Type
RADIATION
Shorter radiation therapy means that a higher dose will be offered. To limit side effects of exposure to a high dose, a medical device protecting the rectum will be used. The medical device to be used is called SpaceOAR hydrogel (device). The SpaceOAR hydrogel creates space between the rectum and the prostate, making it much less likely that the rectum is exposed to radiation. It is injected into place prior to the start of radiation treatment using a needle. Patients may be awake or asleep under local anesthesia for the procedure. SpaceOAR hydrogel is not painful, it remains stable during radiation therapy and then is gradually absorbed by the body over the course of approximately six months, once radiation therapy has been completed.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Stereotactic Body Radiation Therapy (SBRT)
Shorter radiation therapy means that a higher dose will be offered. To limit side effects of exposure to a high dose, a medical device protecting the rectum will be used. The medical device to be used is called SpaceOAR hydrogel (device). The SpaceOAR hydrogel creates space between the rectum and the prostate, making it much less likely that the rectum is exposed to radiation. It is injected into place prior to the start of radiation treatment using a needle. Patients may be awake or asleep under local anesthesia for the procedure. SpaceOAR hydrogel is not painful, it remains stable during radiation therapy and then is gradually absorbed by the body over the course of approximately six months, once radiation therapy has been completed.
Intervention Type
RADIATION
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Space OAR Gel
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Histologically proven adenocarcinoma of the prostate. Tl-2b (AJCC 7th edition) Gleason score 6 or 7 (3+4)) or Gleason 7(4+3) and recent PSA \< 10 (less than 30 days; must obtained \>90 days from stopping dutasteride or \>30 days from stopping finasteride)
Recent PSA under 15 ng/dL (less than 30 days; must obtained \>90 days from stopping dutasteride or \>30 days from stopping finasteride) OR Gleason 7(4+3) and recent PSA \< 10 (less than 30 days; must obtained \>90 days from stopping dutasteride or \>30 days from stopping finasteride)
International Prostate Symptom Score \<16 Prostate gland volume\< 80cc
Zubrod Performance Status 0-1 within 60 days prior to registration
Age \>: 18
Patient must be able to provide study-specific informed consent prior to study entry.
Recent PSA under 15 ng/dL (less than 30 days; must obtained \>90 days from stopping dutasteride or \>30 days from stopping finasteride) OR Gleason 7(4+3) and recent PSA \< 10 (less than 30 days; must obtained \>90 days from stopping dutasteride or \>30 days from stopping finasteride)
International Prostate Symptom Score \<16 Prostate gland volume\< 80cc
Zubrod Performance Status 0-1 within 60 days prior to registration
Age \>: 18
Patient must be able to provide study-specific informed consent prior to study entry.
Exclusion Criteria
Patients who opt to receive another treatment modality, such as surgery, or undergo active surveillance.
Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. All patients with in situ carcinoma are eligible for this study (for example, carcinoma in situ of the oral cavity) except patients with carcinoma of the bladder (including in situ bladder cancer or superficial bladder cancer).
Evidence of distant metastases
Regional lymph node involvement
Previous radical surgery (prostatectomy), cryosurgery, or HIFU for prostate cancer Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy Previous hormonal therapy, such as LHRH agonists or antagonists, anti-androgens, estrogens, or surgical castration (orchiectomy)
Use of finasteride within 30 days prior to registration. PSA should not be obtained prior to 30 days after stopping finasteride.
Use of dutasteride within 90 days prior to registration. PSA should not be obtained prior to 90 days after stopping dutasteride.
Previous or concurrent cytotoxic chemotherapy for prostate cancer Severe, active co-morbidity, defined as follows:
Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
Transmural myocardial infarction within the last 6 months
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol. (Patients on Coumadin or other blood thinning agents are eligible for this study.)
Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. All patients with in situ carcinoma are eligible for this study (for example, carcinoma in situ of the oral cavity) except patients with carcinoma of the bladder (including in situ bladder cancer or superficial bladder cancer).
Evidence of distant metastases
Regional lymph node involvement
Previous radical surgery (prostatectomy), cryosurgery, or HIFU for prostate cancer Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy Previous hormonal therapy, such as LHRH agonists or antagonists, anti-androgens, estrogens, or surgical castration (orchiectomy)
Use of finasteride within 30 days prior to registration. PSA should not be obtained prior to 30 days after stopping finasteride.
Use of dutasteride within 90 days prior to registration. PSA should not be obtained prior to 90 days after stopping dutasteride.
Previous or concurrent cytotoxic chemotherapy for prostate cancer Severe, active co-morbidity, defined as follows:
Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
Transmural myocardial infarction within the last 6 months
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol. (Patients on Coumadin or other blood thinning agents are eligible for this study.)
Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
Minimum Eligible Age
18 Years
Eligible Sex
MALE
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boston Scientific Corporation
INDUSTRY
Sponsor Role
collaborator
Fabio Cury
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Fabio Cury
Principal Investigator
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Fabio Cury, MD
Role: PRINCIPAL_INVESTIGATOR
McGill University Health Centre- Cedars Cancer Centre
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
McGill University Health Centre-Cedars Cancer Centre
Montreal, Quebec, Canada
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
Canada
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
King CR, Fowler JF. A simple analytic derivation suggests that prostate cancer alpha/beta ratio is low. Int J Radiat Oncol Biol Phys. 2001 Sep 1;51(1):213-4. doi: 10.1016/s0360-3016(01)01651-0. No abstract available.
Reference Type
BACKGROUND
Fowler JF, Ritter MA, Chappell RJ, Brenner DJ. What hypofractionated protocols should be tested for prostate cancer? Int J Radiat Oncol Biol Phys. 2003 Jul 15;56(4):1093-104. doi: 10.1016/s0360-3016(03)00132-9.
Reference Type
BACKGROUND
King CR, Brooks JD, Gill H, Presti JC Jr. Long-term outcomes from a prospective trial of stereotactic body radiotherapy for low-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2012 Feb 1;82(2):877-82. doi: 10.1016/j.ijrobp.2010.11.054. Epub 2011 Feb 6.
Reference Type
BACKGROUND
Katz AJ, Santoro M, Ashley R, Diblasio F, Witten M. Stereotactic body radiotherapy for organ-confined prostate cancer. BMC Urol. 2010 Feb 1;10:1. doi: 10.1186/1471-2490-10-1.
Reference Type
BACKGROUND
Fuller DB, Naitoh J, Lee C, Hardy S, Jin H. Virtual HDR CyberKnife treatment for localized prostatic carcinoma: dosimetry comparison with HDR brachytherapy and preliminary clinical observations. Int J Radiat Oncol Biol Phys. 2008 Apr 1;70(5):1588-97. doi: 10.1016/j.ijrobp.2007.11.067.
Reference Type
BACKGROUND
Faria S, Ruo R, Cury F, Duclos M, Souhami L. Acute and late toxicity in high-risk prostate cancer patients treated with androgen suppression and hypofractionated pelvic radiation therapy. Pract Radiat Oncol. 2017 Jul-Aug;7(4):264-269. doi: 10.1016/j.prro.2017.01.003. Epub 2017 Jan 20.
Reference Type
BACKGROUND
Faria SL, Neto OB, Cury F, Shenouda G, Russel R, Souhami L. Moderate hypofractionated external beam radiotherapy alone for intermediate risk prostate cancer: long term outcomes. Can J Urol. 2016 Apr;23(2):8209-14.
Reference Type
BACKGROUND
Patel N, Faria S, Cury F, David M, Duclos M, Shenouda G, Ruo R, Souhami L. Hypofractionated radiation therapy (66 Gy in 22 fractions at 3 Gy per fraction) for favorable-risk prostate cancer: long-term outcomes. Int J Radiat Oncol Biol Phys. 2013 Jul 1;86(3):534-9. doi: 10.1016/j.ijrobp.2013.02.010. Epub 2013 Apr 15.
Reference Type
BACKGROUND
Rene N, Faria S, Cury F, David M, Duclos M, Shenouda G, Souhami L. Hypofractionated radiotherapy for favorable risk prostate cancer. Int J Radiat Oncol Biol Phys. 2010 Jul 1;77(3):805-10. doi: 10.1016/j.ijrobp.2009.05.047.
Reference Type
BACKGROUND
Catton CN, Lukka H, Gu CS, Martin JM, Supiot S, Chung PWM, Bauman GS, Bahary JP, Ahmed S, Cheung P, Tai KH, Wu JS, Parliament MB, Tsakiridis T, Corbett TB, Tang C, Dayes IS, Warde P, Craig TK, Julian JA, Levine MN. Randomized Trial of a Hypofractionated Radiation Regimen for the Treatment of Localized Prostate Cancer. J Clin Oncol. 2017 Jun 10;35(17):1884-1890. doi: 10.1200/JCO.2016.71.7397. Epub 2017 Mar 15.
Reference Type
BACKGROUND
Lee WR, Dignam JJ, Amin MB, Bruner DW, Low D, Swanson GP, Shah AB, D'Souza DP, Michalski JM, Dayes IS, Seaward SA, Hall WA, Nguyen PL, Pisansky TM, Faria SL, Chen Y, Koontz BF, Paulus R, Sandler HM. Randomized Phase III Noninferiority Study Comparing Two Radiotherapy Fractionation Schedules in Patients With Low-Risk Prostate Cancer. J Clin Oncol. 2016 Jul 10;34(20):2325-32. doi: 10.1200/JCO.2016.67.0448. Epub 2016 Apr 4.
Reference Type
BACKGROUND
Dearnaley D, Syndikus I, Mossop H, Khoo V, Birtle A, Bloomfield D, Graham J, Kirkbride P, Logue J, Malik Z, Money-Kyrle J, O'Sullivan JM, Panades M, Parker C, Patterson H, Scrase C, Staffurth J, Stockdale A, Tremlett J, Bidmead M, Mayles H, Naismith O, South C, Gao A, Cruickshank C, Hassan S, Pugh J, Griffin C, Hall E; CHHiP Investigators. Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-year outcomes of the randomised, non-inferiority, phase 3 CHHiP trial. Lancet Oncol. 2016 Aug;17(8):1047-1060. doi: 10.1016/S1470-2045(16)30102-4. Epub 2016 Jun 20.
Reference Type
BACKGROUND
Tang CI, Loblaw DA, Cheung P, Holden L, Morton G, Basran PS, Tirona R, Cardoso M, Pang G, Gardner S, Cesta A. Phase I/II study of a five-fraction hypofractionated accelerated radiotherapy treatment for low-risk localised prostate cancer: early results of pHART3. Clin Oncol (R Coll Radiol). 2008 Dec;20(10):729-37. doi: 10.1016/j.clon.2008.08.006. Epub 2008 Oct 5.
Reference Type
BACKGROUND
McBride SM, Wong DS, Dombrowski JJ, Harkins B, Tapella P, Hanscom HN, Collins SP, Kaplan ID. Hypofractionated stereotactic body radiotherapy in low-risk prostate adenocarcinoma: preliminary results of a multi-institutional phase 1 feasibility trial. Cancer. 2012 Aug 1;118(15):3681-90. doi: 10.1002/cncr.26699. Epub 2011 Dec 13.
Reference Type
BACKGROUND
Madsen BL, Hsi RA, Pham HT, Fowler JF, Esagui L, Corman J. Stereotactic hypofractionated accurate radiotherapy of the prostate (SHARP), 33.5 Gy in five fractions for localized disease: first clinical trial results. Int J Radiat Oncol Biol Phys. 2007 Mar 15;67(4):1099-105. doi: 10.1016/j.ijrobp.2006.10.050.
Reference Type
BACKGROUND
Loblaw A, Cheung P, D'Alimonte L, Deabreu A, Mamedov A, Zhang L, Tang C, Quon H, Jain S, Pang G, Nam R. Prostate stereotactic ablative body radiotherapy using a standard linear accelerator: toxicity, biochemical, and pathological outcomes. Radiother Oncol. 2013 May;107(2):153-8. doi: 10.1016/j.radonc.2013.03.022. Epub 2013 May 3.
Reference Type
BACKGROUND
Lin YW, Lin LC, Lin KL. The early result of whole pelvic radiotherapy and stereotactic body radiotherapy boost for high-risk localized prostate cancer. Front Oncol. 2014 Oct 31;4:278. doi: 10.3389/fonc.2014.00278. eCollection 2014.
Reference Type
BACKGROUND
Ju AW, Wang H, Oermann EK, Sherer BA, Uhm S, Chen VJ, Pendharkar AV, Hanscom HN, Kim JS, Lei S, Suy S, Lynch JH, Dritschilo A, Collins SP. Hypofractionated stereotactic body radiation therapy as monotherapy for intermediate-risk prostate cancer. Radiat Oncol. 2013 Jan 31;8:30. doi: 10.1186/1748-717X-8-30.
Reference Type
BACKGROUND
King CR, Freeman D, Kaplan I, Fuller D, Bolzicco G, Collins S, Meier R, Wang J, Kupelian P, Steinberg M, Katz A. Stereotactic body radiotherapy for localized prostate cancer: pooled analysis from a multi-institutional consortium of prospective phase II trials. Radiother Oncol. 2013 Nov;109(2):217-21. doi: 10.1016/j.radonc.2013.08.030. Epub 2013 Sep 20.
Reference Type
BACKGROUND
Friedland JL, Freeman DE, Masterson-McGary ME, Spellberg DM. Stereotactic body radiotherapy: an emerging treatment approach for localized prostate cancer. Technol Cancer Res Treat. 2009 Oct;8(5):387-92. doi: 10.1177/153303460900800509.
Reference Type
BACKGROUND
Chen LN, Suy S, Uhm S, Oermann EK, Ju AW, Chen V, Hanscom HN, Laing S, Kim JS, Lei S, Batipps GP, Kowalczyk K, Bandi G, Pahira J, McGeagh KG, Collins BT, Krishnan P, Dawson NA, Taylor KL, Dritschilo A, Lynch JH, Collins SP. Stereotactic body radiation therapy (SBRT) for clinically localized prostate cancer: the Georgetown University experience. Radiat Oncol. 2013 Mar 13;8:58. doi: 10.1186/1748-717X-8-58.
Reference Type
BACKGROUND
Bolzicco G, Favretto MS, Scremin E, Tambone C, Tasca A, Guglielmi R. Image-guided stereotactic body radiation therapy for clinically localized prostate cancer: preliminary clinical results. Technol Cancer Res Treat. 2010 Oct;9(5):473-7. doi: 10.1177/153303461000900505.
Reference Type
BACKGROUND
Katz AJ, Kang J. Stereotactic body radiotherapy as treatment for organ confined low- and intermediate-risk prostate carcinoma, a 7-year study. Front Oncol. 2014 Sep 2;4:240. doi: 10.3389/fonc.2014.00240. eCollection 2014.
Reference Type
BACKGROUND
Davis J, Sharma S, Shumway R, Perry D, Bydder S, Simpson CK, D'Ambrosio D. Stereotactic Body Radiotherapy for Clinically Localized Prostate Cancer: Toxicity and Biochemical Disease-Free Outcomes from a Multi-Institutional Patient Registry. Cureus. 2015 Dec 4;7(12):e395. doi: 10.7759/cureus.395.
Reference Type
BACKGROUND
Katz A, Formenti SC, Kang J. Predicting Biochemical Disease-Free Survival after Prostate Stereotactic Body Radiotherapy: Risk-Stratification and Patterns of Failure. Front Oncol. 2016 Jul 8;6:168. doi: 10.3389/fonc.2016.00168. eCollection 2016.
Reference Type
BACKGROUND
Kim DN, Straka C, Cho LC, Lotan Y, Yan J, Kavanagh B, Raben D, Cooley S, Brindle J, Xie XJ, Pistenmaa D, Timmerman R. Early and multiple PSA bounces can occur following high-dose prostate stereotactic body radiation therapy: Subset analysis of a phase 1/2 trial. Pract Radiat Oncol. 2017 Jan-Feb;7(1):e43-e49. doi: 10.1016/j.prro.2016.06.010. Epub 2016 Jun 24.
Reference Type
BACKGROUND
Quon HC, Musunuru HB, Cheung P, Pang G, Mamedov A, D'Alimonte L, Deabreu A, Zhang L, Loblaw A. Dose-Escalated Stereotactic Body Radiation Therapy for Prostate Cancer: Quality-of-Life Comparison of Two Prospective Trials. Front Oncol. 2016 Aug 29;6:185. doi: 10.3389/fonc.2016.00185. eCollection 2016.
Reference Type
BACKGROUND
Avkshtol V, Dong Y, Hayes SB, Hallman MA, Price RA, Sobczak ML, Horwitz EM, Zaorsky NG. A comparison of robotic arm versus gantry linear accelerator stereotactic body radiation therapy for prostate cancer. Res Rep Urol. 2016 Aug 18;8:145-58. doi: 10.2147/RRU.S58262. eCollection 2016.
Reference Type
BACKGROUND
Prada PJ, Cardenal J, Blanco AG, Anchuelo J, Ferri M, Fernandez G, Arrojo E, Vazquez A, Pacheco M, Fernandez J. High-dose-rate interstitial brachytherapy as monotherapy in one fraction for the treatment of favorable stage prostate cancer: Toxicity and long-term biochemical results. Radiother Oncol. 2016 Jun;119(3):411-6. doi: 10.1016/j.radonc.2016.04.006. Epub 2016 Apr 22.
Reference Type
BACKGROUND
Jawad MS, Dilworth JT, Gustafson GS, Ye H, Wallace M, Martinez A, Chen PY, Krauss DJ. Outcomes Associated With 3 Treatment Schedules of High-Dose-Rate Brachytherapy Monotherapy for Favorable-Risk Prostate Cancer. Int J Radiat Oncol Biol Phys. 2016 Mar 15;94(4):657-66. doi: 10.1016/j.ijrobp.2015.10.011. Epub 2015 Nov 10.
Reference Type
BACKGROUND
Hoskin P, Rojas A, Lowe G, Bryant L, Ostler P, Hughes R, Milner J, Cladd H. High-dose-rate brachytherapy alone for localized prostate cancer in patients at moderate or high risk of biochemical recurrence. Int J Radiat Oncol Biol Phys. 2012 Mar 15;82(4):1376-84. doi: 10.1016/j.ijrobp.2011.04.031. Epub 2011 Jun 15.
Reference Type
BACKGROUND
Ghilezan M, Martinez A, Gustason G, Krauss D, Antonucci JV, Chen P, Fontanesi J, Wallace M, Ye H, Casey A, Sebastian E, Kim L, Limbacher A. High-dose-rate brachytherapy as monotherapy delivered in two fractions within one day for favorable/intermediate-risk prostate cancer: preliminary toxicity data. Int J Radiat Oncol Biol Phys. 2012 Jul 1;83(3):927-32. doi: 10.1016/j.ijrobp.2011.05.001. Epub 2011 Dec 23.
Reference Type
BACKGROUND
Morton G, Chung HT, McGuffin M, Helou J, D'Alimonte L, Ravi A, Cheung P, Szumacher E, Liu S, Al-Hanaqta M, Zhang L, Mamedov A, Loblaw A. Prostate high dose-rate brachytherapy as monotherapy for low and intermediate risk prostate cancer: Early toxicity and quality-of life results from a randomized phase II clinical trial of one fraction of 19Gy or two fractions of 13.5Gy. Radiother Oncol. 2017 Jan;122(1):87-92. doi: 10.1016/j.radonc.2016.10.019. Epub 2016 Nov 4.
Reference Type
BACKGROUND
Anwar M, Weinberg V, Seymour Z, Hsu IJ, Roach M 3rd, Gottschalk AR. Outcomes of hypofractionated stereotactic body radiotherapy boost for intermediate and high-risk prostate cancer. Radiat Oncol. 2016 Jan 21;11:8. doi: 10.1186/s13014-016-0585-y.
Reference Type
BACKGROUND
Hamstra DA, Mariados N, Sylvester J, Shah D, Karsh L, Hudes R, Beyer D, Kurtzman S, Bogart J, Hsi RA, Kos M, Ellis R, Logsdon M, Zimberg S, Forsythe K, Zhang H, Soffen E, Francke P, Mantz C, Rossi P, DeWeese T, Daignault-Newton S, Fischer-Valuck BW, Chundury A, Gay H, Bosch W, Michalski J. Continued Benefit to Rectal Separation for Prostate Radiation Therapy: Final Results of a Phase III Trial. Int J Radiat Oncol Biol Phys. 2017 Apr 1;97(5):976-985. doi: 10.1016/j.ijrobp.2016.12.024. Epub 2016 Dec 23.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019-4650
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
SBRT vs. Conventional Fractionation With HDR Boost for Prostate Cancer
NCT04861415
RECRUITING
NA
Post-Prostatectomy Linac-Based Ultrahypofractionated Radiotherapy for Patients With Localized Prostate Cancer
NCT04067570
ACTIVE_NOT_RECRUITING
NA
Prostate Boost Irradiation With Stereotactic Body RT (SBRT)
NCT03380806
UNKNOWN
PHASE2
Phase II Randomized Trial of 2 Versus 5 Fraction Prostate Stereotactic Ablative Radiotherapy for Intermediate Risk Prostate Cancer
NCT06835725
RECRUITING
PHASE2
5 Fractions of Pelvic SABR With Intra Prostatic SABR Boost:
NCT04245670
UNKNOWN
NA
Improving Sexual Quality of Life - Randomized Trial of Two vs Five MRI Guided SABR Treatments for Prostate Cancer
NCT05600400
RECRUITING
NA
Hypofractionated Stereotactic Body Radiation Therapy as a Boost to the Prostate
NCT01508390
ACTIVE_NOT_RECRUITING
NA
Phase I Study MR-guided SBRT to PCa
NCT03935308
WITHDRAWN
NA
Stereotactic Body Radiation Therapy in Treating Patients With Localized Prostate Cancer That Have Undergone Surgery
NCT03541850
ACTIVE_NOT_RECRUITING
PHASE2
Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer
NCT00547339
COMPLETED
PHASE1/PHASE2
PRORAD-5 PROstate RADiation in 5 Fractions: Phase Ib Five Fraction Radiotherapy for Patients With Advanced Prostate Cancer
NCT06369246
RECRUITING
PHASE1
Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy
NCT03253744
COMPLETED
PHASE1
Feasibility Trial Of Image Guided External Beam Radiotherapy With Or Without High Dose Rate Brachytherapy Boost In Men With Intermediate-Risk Prostate Cancer
NCT01982786
COMPLETED
NA
MRI-guided Stereotactic Body Radiotherapy (SBRT) With Simultaneous Integrated Boost for Prostate Cancer
NCT03664193
COMPLETED
NA
Hypofractionated Stereotactic Body Radiation Therapy for Patients With Prostate Cancer That Was Removed by Surgery
NCT02446366
UNKNOWN
NA
Proton-Based Stereotactic Ablative Body Radiotherapy for Prostate Cancer
NCT03159676
ACTIVE_NOT_RECRUITING
Using Rectal Hydrogel Spacer for Salvage SABR in Prostate Cancer
NCT05597852
RECRUITING
NA
24 Gy in One Fraction Urethral-sparing "HDR Like" SBRT for Prostate Cancer
NCT05936736
RECRUITING
NA
Hypofractionated Stereotactic Boost in Prostate Cancer
NCT01596816
COMPLETED
PHASE2
MRI Guided SBRT for Localized Prostate Cancer
NCT03778112
ACTIVE_NOT_RECRUITING
NA
Focal Salvage HDR Brachytherapy for the Treatment of Prostate Cancer
NCT01583920
ACTIVE_NOT_RECRUITING
NA
Rectal Spacers in Prostate Cancer Patients Undergoing Radiation Therapy
NCT06599476
ACTIVE_NOT_RECRUITING
NA
Adaptive MR-guided SBRT for Localized Prostate Cancer
NCT04571762
NOT_YET_RECRUITING
NA
Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer
NCT00941915
COMPLETED
NA
Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer Being Treated With Stereotactic Body Radiotherapy
NCT04905069
ACTIVE_NOT_RECRUITING
NA