Health TrialsbyHealthPanel

Whole Versus Partial Gland Boost During Prostate SBRT

ConditionsProstate CancerProstate Adenocarcinoma
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexMale
Age19+
SponsorUniversity of Nebraska

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prostate stereotactic body radiotherapy with whole gland boost

    Radiation

    External beam radiation therapy delivered via linear accelerator-based SBRT using simultaneous integrated boost

  • 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.

Treatment groups

186 Participants
are divided into 2 treatment groups
Group A: Arm A: boost to prostate aloneActive comparator 1 intervention
Group B: Arm B: boost to dominant intra-prostatic lesion (DIL)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
From 6 months post-treatment to 2 years post-treatment
2

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

Time frame
From 6 months post-treatment to 2 years post-treatment

Secondary outcomes

1

Biochemical Progression-Free Survival

Time from initiation of study treatment to biochemical disease progression or death from any cause.

Time frame
From initiation of study treatment to 5 years post-treatment
2

Acute Gastrointestinal Toxicity

Cumulative incidence of acute gastrointestinal (GI) toxicities assessed using CTCAE, Radiation Therapy Oncology Group (RTOG), and Expanded Prostate Cancer Index Composite (EPIC) domains.

Time frame
From end of treatment to 6 months post-treatment
3

Acute Genitourinary Toxicity

Cumulative incidence of acute genitourinary (GU) toxicities assessed using CTCAE, RTOG, and EPIC domains.

Time frame
From end of treatment to 6 months post-treatment
4

Chronic Gastrointestinal Toxicity

Incidence of chronic gastrointestinal (GI) toxicities assessed using CTCAE, RTOG, and EPIC domains.

Time frame
From 6 months post-treatment to 5 years post-treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Nebraska

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: