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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00120414 | Other Identifier | University of Michigan |
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This is a single-arm prospective non-randomized, non-blinded trial to assess the safety of neoadjuvant stereotactic body radiation therapy (SBRT) before surgery in high risk prostate cancer patients.
Radiation therapy will be delivered over 5 treatment sessions for approximately 1.5 weeks total.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBRT | Experimental | Stereotactic Body Radiation Therapy (SBRT) will be delivered over 5 treatment sessions for approximately 1.5 weeks total. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiation Therapy | Radiation | Delivered over 5 treatment sessions for approximately 1.5 weeks total. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of Neoadjuvant SBRT | The MTD is defined as the SBRT dose that with radical prostatectomy induces dose-limiting toxicity in 28% of subjects or less. | 6-week post-prostatectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Urinary Incontinence | Urinary incontinence will be scored according to Common Toxicity Criteria for Adverse Events (CTCAE) v.4.0 (Grade 1 = Occasional, Grade 2 = Spontaneous, pads indicated, Grade 3 = Intervention indicated) | up to one year post treatment |
| Incidence of Urinary Stricture |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Spratt, M.D. | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35878714 | Derived | Hammer L, Jiang R, Hearn J, Lashbrook J, Mitchell A, Daignault-Newton S, Dess RT, Jackson WC, Reichert Z, Alumkal JJ, Kaffenberger S, George A, Montgomery J, Salami SS, Morgan TM, Miller D, Wittman D, Hollenbeck B, Mehra R, Davenport MS, Sun Y, Schipper M, Palapattu G, Spratt DE. A Phase I Trial of Neoadjuvant Stereotactic Body Radiotherapy Prior to Radical Prostatectomy for Locally Advanced Prostate Cancer. Int J Radiat Oncol Biol Phys. 2023 Jan 1;115(1):132-141. doi: 10.1016/j.ijrobp.2022.07.016. Epub 2022 Jul 22. |
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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 |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| Radical Prostatectomy | Procedure | Open, laparoscopic, or robotic radical prostatectomy and pelvic lymph node dissection to remove the prostate, seminal vesicles, and pelvic lymph nodes. |
|
Urinary stricture, according to Common Toxicity Criteria for Adverse Events (CTCAE) v.4.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening, Grade 5 = death.) |
| up to one year post treatment |
| Incidence of Urinary Bother | Urinary bother, according to Common Toxicity Criteria for Adverse Events (CTCAE) v.4.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening, Grade 5 = death.) | up to one year post treatment |
| Rectal Toxicity | Rectal Toxicity, according to Common Toxicity Criteria for Adverse Events (CTCAE) v.4.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening, Grade 5 = death.) | up to one year post treatment |
| Number of Patients with Positive Surgical Margins | Surgical specimens will be evaluated by the study pathologist to determine rate of margin positivity. | 4-10 weeks post radiation therapy |
| Number of Patients with Extracapsular Extension | Surgical specimens will be evaluated by the study pathologist to determine rate of extracapsular extension. | 4-10 weeks post radiation therapy |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |