Prostate Adenocarcinoma, Prostate Cancer
Conditions
Keywords
Prostate SBRT, Stereotactic Body Radiotherapy, Dose Escalation, Dominant Intraprostatic Lesion, DIL, Radiation Therapy, Genitourinary Toxicity, Gastrointestinal Toxicity, CTCAE, RTOG, EPIC
Brief summary
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.
Detailed description
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.
Interventions
RADIATIONProstate stereotactic body radiotherapy with whole gland boost
External beam radiation therapy delivered via linear accelerator-based SBRT using simultaneous integrated boost
RADIATIONProstate stereotactic body radiotherapy with DIL boost
External beam radiation therapy delivered via linear accelerator-based SBRT using simultaneous integrated boost to the dominant intra-prostatic lesion.
Sponsors
University of Nebraska
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults ≥19 years of age 2. Patients with a diagnosis of prostate adenocarcinoma for which stereotactic body radiotherapy (SBRT) to the prostate ± proximal seminal vesicles is being offered 3. Prostate gland volume \<100 cc prior to initiation of androgen deprivation therapy (ADT), as reported at time of biopsy or by imaging (e.g., ultrasound, MRI, or CT) 4. PI-RADS 4 or 5 lesion seen on pre-treatment MRI 5. IPSS/AUA symptom score less than 16
Exclusion criteria
1. Prior treatment for prostate cancer 2. Prior solid cancer diagnosis within the last 5 years 3. Any history of anal or rectal cancer 4. Any history of invasive carcinoma of the bladder 5. History of prior circumferential resection of the rectum (such as LAR or APR)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Grade 2 or Higher Chronic Genitourinary Toxicity | From 6 months post-treatment to 2 years post-treatment | Cumulative incidence of grade 2 or higher chronic genitourinary (GU) toxicities assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 |
| Grade 2 or Higher Chronic Gastrointestinal Toxicity | From 6 months post-treatment to 2 years post-treatment | Cumulative incidence of grade 2 or higher chronic gastrointestinal (GI) toxicities assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical Progression-Free Survival | From initiation of study treatment to 5 years post-treatment | Time from initiation of study treatment to biochemical disease progression or death from any cause. |
| Acute Gastrointestinal Toxicity | From end of treatment to 6 months post-treatment | Cumulative incidence of acute gastrointestinal (GI) toxicities assessed using CTCAE, Radiation Therapy Oncology Group (RTOG), and Expanded Prostate Cancer Index Composite (EPIC) domains. |
| Acute Genitourinary Toxicity | From end of treatment to 6 months post-treatment | Cumulative incidence of acute genitourinary (GU) toxicities assessed using CTCAE, RTOG, and EPIC domains. |
| Chronic Gastrointestinal Toxicity | From 6 months post-treatment to 5 years post-treatment | Incidence of chronic gastrointestinal (GI) toxicities assessed using CTCAE, RTOG, and EPIC domains. |
| Chronic Genitourinary Toxicity | From 6 months post-treatment to 5 years post-treatment | Incidence of chronic genitourinary (GU) toxicities assessed using CTCAE, RTOG, and EPIC domains. |
Countries
United States
Contacts
CONTACTKrishna Gottipati, MS
CONTACTIIT Office Gottipati
PRINCIPAL_INVESTIGATORMichael Baine, MD, PhD
University of Nebraska medicine
Outcome results
None listed