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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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A randomized controlled open-label trial in patients with high risk prostate cancer. Eligible and consenting patients will be randomly allocated to receive stereotactic body radiotherapy (SBRT) boost to prostate or conventional radiotherapy boost to prostate in 1:1 ratio. Prostate radiotherapy boost will be administered after standard pelvic radiotherapy. Subjects will be followed for 24 months post radiation treatment for Quality of Life assessment and toxicity.
In this study we investigate stereotactic body radiotherapy (SBRT) as a boost radiotherapy treatment, following pelvic radiotherapy, in patients with high risk prostate cancer (PrCa) treated with Androgen Deprivation Therapy (ADT). One hundred patients with localized high risk PrCa will receive ADT for a total of 3 years. Three months after initiation of ADT all patients will receive pelvic (lymph node and prostate) treatment of 45Gy in 25 fractions (5 days per week). Then patients will be randomized to receive either The conventional radiotherapy (CRT) of 33 - 35 Gy in 16 fractions (5 days per week - over 22 days) (comparator arm) or SBRT boost treatment of 19.5 - 21 Gy in three fractions (1 treatment per week - over 22days) (experimental arm). SBRT boost treatment will be delivered with either cyberknife or VMAT technique.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | Conventional Radiotherapy (CRT) Prostate Boost Pelvic Radiation LHRH agonist |
|
| Arm 2 | Experimental | Stereotactic Body Radiotherapy (SBRT) Prostate Boost Pelvic Radiation LHRH agonist |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LHRH agonist | Drug | Standard LHRH agonist for 3 years |
|
| Measure | Description | Time Frame |
|---|---|---|
| Short Term Quality of Life (QoL) | To compare early QoL (up to 6 months post RT) in patients with high risk adenocarcinoma of the prostate treated with ADT and RT in the form of pelvic nodal irradiation and prostate boost with standard fractionation, or pelvic nodal irradiation and prostate boost with SBRT using Cyberknife or VMAT. QoL, defined as bowel and bladder function and bother after PrCa treatment, will be measured prior to and at regular intervals after completion of radiotherapy using the established Prostate QoL (The Expanded Prostate cancer Index Composite (EPIC-26 instrument)). Higher EPIC score represent a better outcome | up to 6 months post radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Long Term Quality of Life (QoL) | long term QoL QoL, defined as bowel and bladder function and bother after PrCa treatment, will be measured prior to and at regular intervals up to 24 months month after completion of radiotherapy using the established Prostate QoL (The Expanded Prostate cancer Index Composite (EPIC-26 instrument)). Higher EPIC score represent a better outcome | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Theos Tsakiridis, Senior Principle Investigator, MD, FRCPC | Contact | 905-387-9495 | theos.tsakiridis@hhsc.ca | |
| Naghmeh Isfahanian, Junior Principle Investigator, MD, FRCPC | Contact | 289-707-4883 | isfahanian@hhsc.ca , naghmeh_isf@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Juravinski Cancer Centre | Recruiting | Hamilton | Ontario | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40287937 | Derived | Gouveia A, Mesci A, Isfahanian N, Dayes I, Quan K, Goldberg M, Schnarr KL, Lukka H, Cuthbert D, Hallock A, Douvi G, Wright J, Swaminath A, Chow T, Diamond K, Hajdok G, Maharaj L, Ewusie J, Tsakiridis T. Primary Analysis of (NCT03380806) a Phase II Randomized Trial of Stereotactic Body Radiotherapy Boost Versus Conventional Fractionation External Beam Radiotherapy Boost in Unfavorable-Intermediate and High-Risk Prostate Cancer. Prostate. 2025 Jul;85(10):977-985. doi: 10.1002/pros.24905. Epub 2025 Apr 27. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| C493311 | luprolide acetate gel depot |
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Pelvic Radiation | Radiation | Pelvic Radiation |
|
| Stereotactic Body Radiotherapy (SBRT) | Radiation | SBRT: 19.5 - 21 Gy in three fractions (1 treatment per week - over 22days) |
|
| Conventional Radiotherapy (CRT) Prostate Boost | Radiation | CRT: 33 - 35 Gy in 16 fractions (5 days per week - over 22 days) |
|
| Urinary function assessment | short and long term quality of urinary function (The International Prostate Symptom Score (IPSS)). Total IPSS is between 1-35 / lower score shows better function. | 24 months |
| Late Toxicity | Grade 2-4 treatment related late (12-24 months), bladder and bowel related toxicity evaluated by the Expanded Common Toxicity Criteria of the National Cancer Institute of Canada (NCI) | 12-24 months |
| Walker Family Cancer Centre ,Niagara Health - St. Catharines Site | Recruiting | St. Catharines | Ontario | Canada |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |