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This phase 2/3 randomized trial evaluates whether dose escalation to the dominant intra-prostatic lesion (DIL) compared to whole gland dose escalation during prostate stereotactic body radiotherapy (SBRT) results in differences in genitourinary (GU) and gastrointestinal (GI) toxicities.
This is a phase 2/3 randomized clinical trial evaluating two dose escalation strategies during prostate stereotactic body radiotherapy (SBRT). A total of 186 patients with prostate adenocarcinoma will be enrolled and randomized in a 1:1 ratio to one of two treatment arms.
In both arms, patients will receive 3625 cGy delivered to the planning target volume (PTV) over 5 fractions. In Arm A, patients will receive a boost to the prostate gland. In Arm B, patients will receive a boost to the dominant intra-prostatic lesion (DIL) identified on pre-treatment magnetic resonance imaging (MRI).
The primary objective is to evaluate chronic genitourinary (GU) and gastrointestinal (GI) toxicities grade 2 or higher from 6 months to 2 years post-treatment using the Common Terminology Criteria for Adverse Events (CTCAE). Secondary objectives include evaluation of acute and chronic GU and GI toxicities using CTCAE, Radiation Therapy Oncology Group (RTOG), and Expanded Prostate Cancer Index Composite (EPIC) domains, as well as biochemical progression-free survival at 5 years.
Participants will be followed for up to 5 years after completion of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: boost to prostate alone | Active Comparator | Participants assigned to Arm A will receive external beam radiation therapy consisting of 3625 cGy to the planning target volume (PTV), plus a boost of 4000 cGy to the clinical target volume (CTV), consisting of the prostate alone without a margin. Treatment will be delivered over 5 fractions with at least 36 hours between fractions via simultaneous integrated boost (SIB). |
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| Arm B: boost to dominant intra-prostatic lesion (DIL) | Experimental | Participants assigned to Arm B will receive external beam radiation therapy consisting of 3625 cGy to the planning target volume (PTV), plus a boost of 4500 cGy to the dominant intra-prostatic lesion (DIL). Treatment will be delivered over 5 fractions with at least 36 hours between fractions via simultaneous integrated boost (SIB). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prostate stereotactic body radiotherapy with whole gland boost | Radiation | External beam radiation therapy delivered via linear accelerator-based SBRT using simultaneous integrated boost |
| Measure | Description | Time Frame |
|---|---|---|
| Grade 2 or Higher Chronic Genitourinary Toxicity | Cumulative incidence of grade 2 or higher chronic genitourinary (GU) toxicities assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | From 6 months post-treatment to 2 years post-treatment |
| Grade 2 or Higher Chronic Gastrointestinal Toxicity | Cumulative incidence of grade 2 or higher chronic gastrointestinal (GI) toxicities assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | From 6 months post-treatment to 2 years post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical Progression-Free Survival | Time from initiation of study treatment to biochemical disease progression or death from any cause. | From initiation of study treatment to 5 years post-treatment |
| Acute Gastrointestinal Toxicity |
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Inclusion Criteria:
Exclusion Criteria:
This study includes only male participants because it is limited to patients with prostate adenocarcinoma
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Krishna Gottipati, MS | Contact | 4025593518 | krgottipati@unmc.edu | |
| IIT Office Gottipati | Contact | 4025590963 | IITOFFICE@unmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael Baine, MD, PhD | University of Nebraska medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred & Pamela Buffet Cancer Center | Omaha | Nebraska | 68198 | United States |
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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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| Prostate stereotactic body radiotherapy with DIL boost | Radiation | External beam radiation therapy delivered via linear accelerator-based SBRT using simultaneous integrated boost to the dominant intra-prostatic lesion. |
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Cumulative incidence of acute gastrointestinal (GI) toxicities assessed using CTCAE, Radiation Therapy Oncology Group (RTOG), and Expanded Prostate Cancer Index Composite (EPIC) domains.
| From end of treatment to 6 months post-treatment |
| Acute Genitourinary Toxicity | Cumulative incidence of acute genitourinary (GU) toxicities assessed using CTCAE, RTOG, and EPIC domains. | From end of treatment to 6 months post-treatment |
| Chronic Gastrointestinal Toxicity | Incidence of chronic gastrointestinal (GI) toxicities assessed using CTCAE, RTOG, and EPIC domains. | From 6 months post-treatment to 5 years post-treatment |
| Chronic Genitourinary Toxicity | Incidence of chronic genitourinary (GU) toxicities assessed using CTCAE, RTOG, and EPIC domains. | From 6 months post-treatment to 5 years post-treatment |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |