Radiotherapy for Prostate Cancer

Overseen By IIT Office Gottipati

Age: 18+

Sex: Male

Trial Phase: Phase 2 & 3

Sponsor: University of Nebraska

Disqualifiers: Prior prostate cancer treatment, solid cancer, anal cancer, rectal cancer, bladder carcinoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

Michael Baine, MD, PhD

Principal Investigator

University of Nebraska medicine

Are You a Good Fit for This Trial?

Inclusion Criteria

I am 19 years old or older.

4. PI-RADS 4 or 5 lesion seen on pre-treatment MRI

My prostate gland is smaller than 100 cc before starting hormone therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive stereotactic body radiotherapy (SBRT) with dose escalation over 5 fractions

2 weeks

5 visits (in-person)

Follow-up

Participants are monitored for chronic genitourinary and gastrointestinal toxicities and biochemical progression-free survival

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Prostate stereotactic body radiotherapy with DIL boost
• Prostate stereotactic body radiotherapy with whole gland boost

How Is the Trial Designed?

Group I: Arm B Experimental Treatment 1 Intervention

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).

Group II: Arm A Active Control 1 Intervention

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).

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+