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Radiation Therapy

Prostate SBRT for Prostate Cancer

Phase 1

Waitlist Available

Led By Deborah E Citrin, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 (Karnofsky greater than or equal to 60%)

Patients must have histologically confirmed locally recurrent adenocarcinoma of the prostate after prior radiation (external beam radiation therapy (EBRT) or brachytherapy)

Must not have

Pre-existing and ongoing radiation-related grade 3 bowel or bladder toxicity

Inflammatory bowel disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 weeks after end of treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the maximum tolerated dose and side effects of stereotactic body radiation therapy in people with a local recurrence of prostate cancer after radiation.

Who is the study for?

This trial is for men over 18 with recurrent prostate cancer after radiation, no distant metastatic disease, and an ECOG performance status of ≤2. They must understand the study and consent to participate. Exclusions include HIV patients on certain treatments, liver issues, high PSA without clear scans, prior prostatectomy, severe medical or psychiatric conditions affecting the study outcome.

What is being tested?

The trial tests SBRT's maximum tolerated dose in treating locally recurrent prostate cancer post-radiation. It involves a PET/CT scan using 18F-DCFPyL injection and MRI scans for planning treatment. Participants undergo five SBRT sessions over two weeks with follow-ups including physical exams and questionnaires.

What are the potential side effects?

Potential side effects from SBRT may include skin irritation at the treatment site, fatigue, urinary issues such as increased frequency or discomfort during urination, bowel changes like diarrhea or rectal bleeding, and erectile dysfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself but might not be able to do heavy physical work.

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My prostate cancer came back after radiation treatment.

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I am 18 years old or older.

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My PSA levels rose by at least 2 ng/dL after radiation therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe bowel or bladder issues from past radiation.

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I have inflammatory bowel disease.

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I have active Lupus or active scleroderma.

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I have severe claustrophobia that doesn't improve with anxiety medication.

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I am HIV positive and on medication that increases sensitivity to radiation.

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I have had surgery to remove my prostate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 weeks after end of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 weeks after end of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 weeks after end of treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Maximum Tolerated Dose (MTD)

Secondary study objectives

Biochemical Progression Free Survival (bPFS)

Changes of American Urologic Association (AUA) Symptom Index Quality of Life (QOL) Scores During and After Treatment

Changes of Expanded Prostate Cancer Index Composite (EPIC-26) Quality of Life (QOL) Scores During and After Treatment

+4 more

Other study objectives

Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort 2, Level 2, Arm 2 - Prostate and Tumor IrradiationExperimental Treatment3 Interventions

Arm 2: Prostate and tumor irradiation Arm 2 - 30 gray (Gy) planning target volume (PTV) to Prostate and 42.5 Gy to Tumor PTV Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy; and a reduced dose will be delivered to the entire prostate. Brachytherapy: Participants with locally recurrent prostate cancer after treatment with brachytherapy +/- external beam radiation therapy (EBRT). These participants must have had brachytherapy as part of their treatment.

Group II: Cohort 2, Level 1, Arm 2 - Prostate and Tumor IrradiationExperimental Treatment3 Interventions

Arm 2: Prostate and tumor irradiation Cohort 2, Level 1, Arm 2 - 30 gray (Gy) PTV to Prostate and 40 Gy to Tumor planning target volume (PTV) Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy; and a reduced dose will be delivered to the entire prostate. Brachytherapy: Participants with locally recurrent prostate cancer after treatment with brachytherapy +/- external beam radiation therapy (EBRT). These participants must have had brachytherapy as part of their treatment.

Group III: Cohort 1, Level 2, Arm 1 - Tumor IrradiationExperimental Treatment2 Interventions

Arm 1: Tumor irradiation. Cohort 1, Level 2, Arm 1 - 42.5 gray (Gy) to Tumor planning target volume (PTV) Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy; and a reduced dose will be delivered to the entire prostate. External beam radiation therapy (EBRT): Participants with locally recurrent prostate cancer after treatment with EBRT. These participants cannot have had permanent brachytherapy as part of their treatment.

Group IV: Cohort 1, Level 1, Arm 1: Tumor IrradiationExperimental Treatment2 Interventions

Arm 1: Tumor irradiation. Cohort 1, Level 1, Arm 1 - 40 gray (Gy) to Tumor planning target volume (PTV) Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy. External beam radiation therapy (EBRT): Participants with locally recurrent prostate cancer after treatment with EBRT. These participants cannot have had permanent brachytherapy as part of their treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

18F-DCFPyL

2019

Completed Phase 3

~600

0 / 10Eligibility criteria met