Clinical trial · Interventional
Whole Versus Partial Gland Boost During Prostate SBRT
Whole Versus Partial Gland Boost During Prostate SBRT (Gland Boost)
NCT07574489CI-TRIAL-00116185not yet recruitingPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prostate stereotactic body radiotherapy with DIL boost | Radiation | — | UNRESOLVED |
| Prostate stereotactic body radiotherapy with whole gland boost | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A: boost to prostate alone
- description
- 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).
- interventionNames
- Radiation: Prostate stereotactic body radiotherapy with whole gland boost
- type
- EXPERIMENTAL
- label
- Arm B: boost to dominant intra-prostatic lesion (DIL)
- description
- 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).
- interventionNames
- Radiation: Prostate stereotactic body radiotherapy with DIL boost
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 19 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.