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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 weeks after end of treatment
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD)
Secondary outcome measures
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 outcome measures
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)

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
~350

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,603 Previous Clinical Trials
40,913,258 Total Patients Enrolled
559 Trials studying Prostate Cancer
507,037 Patients Enrolled for Prostate Cancer
Deborah E Citrin, M.D.Principal InvestigatorNational Cancer Institute (NCI)
11 Previous Clinical Trials
753 Total Patients Enrolled
4 Trials studying Prostate Cancer
421 Patients Enrolled for Prostate Cancer

Media Library

Prostate radiation + tumor boost irradiation (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03253744 — Phase 1
Prostate Cancer Research Study Groups: Cohort 2, Level 1, Arm 2 - Prostate and Tumor Irradiation, Cohort 1, Level 1, Arm 1: Tumor Irradiation, Cohort 1, Level 2, Arm 1 - Tumor Irradiation, Cohort 2, Level 2, Arm 2 - Prostate and Tumor Irradiation
Prostate Cancer Clinical Trial 2023: Prostate radiation + tumor boost irradiation Highlights & Side Effects. Trial Name: NCT03253744 — Phase 1
Prostate radiation + tumor boost irradiation (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03253744 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any past experiments that have investigated the efficacy of Tumor Irradiation?

"At present, there are 18 active clinical studies exploring Tumor Irradiation and none of them have progressed to Phase 3. Although the preponderance of these investigations take place in Baltimore, Maryland, research into this topic is conducted in 27 different locations worldwide."

Answered by AI

Is Tumor Irradiation a safe method of treatment for individuals?

"Tumor Irradiation received a score of 1, as there is still limited data available on its safety and efficacy. This evaluation was conducted by our team at Power due to the fact that this trial has not yet progressed beyond Phase 1."

Answered by AI

Is there still capacity for participants in this medical experiment?

"According to clinicaltrials.gov, the current search for participants is ongoing and began on July 5th 2018 with its most recent update being November 24th 2022."

Answered by AI

How many participants are engaging in this experiment?

"Affirmative. According to clinicaltrials.gov, enrollment for this health research is active and ongoing; the trial was first announced on July 5th 2018 with a recent update occurring November 24th 2022. The experiment hopes to involve 46 people at one locale."

Answered by AI

Under what conditions is Tumor Irradiation typically employed?

"Elevated serum prostate specific antigen (PSA) can be managed with tumor irradiation. In addition, this treatment option is also suitable for suspected metastases, positron emission tomography scans, and recurring cases of prostate cancer."

Answered by AI
~3 spots leftby Mar 2025