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Not yet recruiting NCT07574489

Whole Versus Partial Gland Boost During Prostate SBRT

Phase II / Phase III Interventional Prostate Cancer Prostate Adenocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Prostate stereotactic body radiotherapy with whole gland boost, Prostate stereotactic body radiotherapy with DIL boost.
Who it may be relevant to
Registry conditions: Prostate Cancer, Prostate Adenocarcinoma. Basic parameters: from 19 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Whole Versus Partial Gland Boost During Prostate SBRT (Gland Boost)

Overview

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

  • Radiation Prostate stereotactic body radiotherapy with whole gland boost
    External beam radiation therapy delivered via linear accelerator-based SBRT using simultaneous integrated boost
  • Radiation Prostate 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.

Primary outcome measures

  • Grade 2 or Higher Chronic Genitourinary Toxicity [Time frame: From 6 months post-treatment to 2 years post-treatment]
  • Grade 2 or Higher Chronic Gastrointestinal Toxicity [Time frame: From 6 months post-treatment to 2 years post-treatment]
Secondary outcome measures (5)
  • Biochemical Progression-Free Survival [Time frame: From initiation of study treatment to 5 years post-treatment]
  • Acute Gastrointestinal Toxicity [Time frame: From end of treatment to 6 months post-treatment]
  • Acute Genitourinary Toxicity [Time frame: From end of treatment to 6 months post-treatment]
  • Chronic Gastrointestinal Toxicity [Time frame: From 6 months post-treatment to 5 years post-treatment]
  • Chronic Genitourinary Toxicity [Time frame: From 6 months post-treatment to 5 years post-treatment]

Eligibility criteria

Inclusion criteria

  • Adults ≥19 years of age
  • Patients with a diagnosis of prostate adenocarcinoma for which stereotactic body radiotherapy (SBRT) to the prostate ± proximal seminal vesicles is being offered
  • 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)
  • PI-RADS 4 or 5 lesion seen on pre-treatment MRI
  • IPSS/AUA symptom score less than 16

Exclusion criteria

  • Prior treatment for prostate cancer
  • Prior solid cancer diagnosis within the last 5 years
  • Any history of anal or rectal cancer
  • Any history of invasive carcinoma of the bladder
  • History of prior circumferential resection of the rectum (such as LAR or APR)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Fred & Pamela Buffet Cancer Center — Omaha

Identifiers

NCT: NCT07574489 · Gland Boost

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗