Stereotactic Body Radiation Therapy for Recurrent Prostate Cancer (DASBRT-RPC Trial)

Phase 2

Recruiting

Research Sponsored by University of Rochester

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new radiation technique for prostate cancer after surgery that delivers higher doses more quickly, with the help of AI.

Who is the study for?

This trial is for men who've had prostate cancer surgery but now have signs it's back. They need two PSA tests showing a level over 0.02 ng/dl, taken at least 30 days apart. Men with bowel inflammation, recent GI or urinary issues, high PSA levels (>10 ng/dl), spread of cancer beyond the pelvis, or previous pelvic radiation can't join.

What is being tested?

The study is testing a new way to do radiation called Daily-adaptive Stereotactic Body Radiation Therapy (SBRT) using AI and Ethos Plan Adaptive technology. It aims to treat recurrent prostate cancer after surgery more precisely in fewer sessions than traditional methods.

What are the potential side effects?

While not detailed here, SBRT side effects may include fatigue, skin reactions in the treated area, frequent urination with possible discomfort or burning sensation during urination, loose stools or diarrhea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])

The primary objective of the full enrollment Phase II component is to report biochemical recurrence free survival (bPFS).

Secondary study objectives

Distant metastasis free survival

Long term side effects

Need for long term anti-testosterone therapy

Other study objectives

Planning parameters and techniques

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: 2- Pelvic nodal with or without a prostate bed recurrenceExperimental Treatment1 Intervention

Patients who have a radiologic recurrence of prostate cancer in the pelvic node region

Group II: 1 - Prostate bed only recurrenceExperimental Treatment1 Intervention

Patients with confirmed radiologic recurrence of their prostate cancer in the defined region of the previous prostate surgery - commonly referred to as the prostate surgical bed.

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