Number of Participants With Acute Grade ≥3 GI and GU Adverse Events
| Group | Value (Participants) |
|---|---|
| Adaptive Stereotactic Body Radiotherapy (SBRT) | 1 |
Trial · Interventional
Active, not recruitingNot applicableResults postedRegistry dataThis trial does not test a peptide that PepBank tracks.
United States
1 trial · 1 ongoing · 1 with posted results
Adaptive Stereotactic Body Radiation Therapy to the Prostate and Pelvic Nodes With Simultaneous Integrated Boost to the MR-detected Nodule for Patients With High-risk and Unfavorable Intermediate-risk Prostate Cancer
NCT0562836318 Jan 2023 to est. 25 Jul 2030
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This trial is a prospective clinical trial designed to demonstrate the safety and feasibility of whole-pelvis adaptive prostate stereotactic body radiation therapy (SBRT) with a tumor boost to the magnetic resonance (MR)-detected sites of disease. The hypothesis is that this treatment approach will be safe and feasible with \<15% of patients experiencing an acute CTCAEv5 grade ≥3 genitourinary (GU) or gastrointestinal (GI) adverse event.
Experimental
Adaptive stereotactic body radiotherapy (SBRT)
* Treatment consists of adaptive dose-escalated stereotactic body radiotherapy (SBRT) to the pelvic nodes to 25 Gy in 5 once or twice weekly fractions with simultaneous integrated boosts (SIB) to the prostate and proximal seminal vesicles to 36.25 Gy in 5 fractions (full seminal vesicles if involved), to the prostate to 40 Gy in 5 fractions, and to the involved MR-detected nodule(s) to up to 50 Gy in 5 fractions. * Androgen deprivation therapy (ADT) will be administered to study patients according to institutional standard. Unfavorable Intermediate-risk Disease: Patients should receive a minimum of 4 months of ADT. Patients can receive longer duration of ADT at the discretion of the treating physician. High-risk disease: Patients should receive a minimum of 1 year of ADT. Patients can receive up to 2 years of ADT at the discretion of the treating physician.
Outcomes the sponsor listed as primary.
Number of Participants With Acute Grade ≥3 GI and GU Adverse Events
Time frame · From start of radiotherapy through 90 days after start of radiotherapy
Changes in Patient-reported Quality of Life as Measured by EPIC-26
Time frame · At screening, end of radiotherapy (week 5), 3 months after start of radiotherapy, and every 3 months until month 24
-The EPIC-26 is used to assess health related quality of life among persons with prostate cancer. It contains 5 domains of urinary incontinence, urinary irritability/obstructive, bowel, sexual, and hormonal. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life.
Changes in Global Function as Measured by EQ-5D-5L
Time frame · At screening, end of radiotherapy (week 5), 3 months after start of radiotherapy, and every 3 months until month 24
-The EQ-5D-5L is a commonly used and reliable questionnaire used to assess patient perception of their current health state. Patients are asked about their levels of difficulty with mobility, self-care, and usual activities, and about their pain/discomfort and anxiety/depression levels on a 5-point scale where the response "I have no problems" = 1 and "I am unable/have extreme" = 5.
Number of Participants With Acute Grade ≥3 Adverse Events at Least Possibly Related to Radiotherapy
Time frame · From start of radiotherapy through 90 days after start of radiotherapy
Number of Participants With Acute <Grade 3 GI and GU Adverse Events
Time frame · From start of radiotherapy through 90 days after start of radiotherapy
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Participants) |
|---|---|
| Adaptive Stereotactic Body Radiotherapy (SBRT) | 1 |
| Group | Value |
|---|
| Group | Value |
|---|
| Group | Value (Participants) |
|---|---|
| Adaptive Stereotactic Body Radiotherapy (SBRT) | 1 |
| Group | Value (Participants) |
|---|---|
| Adaptive Stereotactic Body Radiotherapy (SBRT) | 24 |
| Group | Value |
|---|
| Group | Value |
|---|
| Group | Value |
|---|
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Adaptive Stereotactic Body Radiotherapy (SBRT)* Treatment consists of adaptive dose-escalated stereotactic body radiotherapy (SBRT) to the pelvic nodes to 25 Gy in 5 once or twice weekly fractions with simultaneous integrated boosts (SIB) to the prostate and proximal seminal vesicles to 36.25 Gy in 5 fractions (full seminal vesicles if involved), to the prostate to 40 Gy in 5 fractions, and to the involved MR-detected nodule(s) to up to 50 Gy in 5 fractions. * Androgen deprivation therapy (ADT) will be administered to study patients according to institutional standard. Unfavorable Intermediate-risk Disease: Patients should receive a minimum of 4 months of ADT. Patients can receive longer duration of ADT at the discretion of the treating physician. High-risk disease: Patients should receive a minimum of 1 year of ADT. Patients can receive up to 2 years of ADT at the discretion of the treating physician. | 1 / 25 | 2 / 25 | 24 / 25 |
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