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Radiation

Reduced-Dose SABR for Prostate Cancer (POTEN-C Trial)

Phase 2

Recruiting

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

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

Must have

Gleason summary score should be less than or equal to 7

Age ≥ 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 months

Awards & highlights

POTEN-C Trial Summary

This trial is testing whether reducing the dose to or 'sparing' neurovascular structures during SABR for localized prostate cancer will improve retention of sexual potency, while retaining excellent oncologic control and other secondary health-related quality of life (HRQOL) endpoints.

Who is the study for?

Men over 18 with localized prostate cancer, good performance status, and a desire to retain sexual function. They must have a PSA ≤20 ng/ml, prostate volume ≤80 grams without severe urinary symptoms or prior treatments for prostate cancer. Participants need an adequate testosterone level and no evidence of metastatic disease.Check my eligibility

What is being tested?

The trial is testing whether sparing neurovascular structures during stereotactic ablative body radiotherapy (SAbR) for localized prostate cancer helps maintain erectile function better than standard SAbR, while still providing effective cancer control.See study design

What are the potential side effects?

Potential side effects include acute and chronic urinary and gastrointestinal issues related to the radiation therapy. Sexual potency may be affected despite the nerve-sparing approach.

POTEN-C Trial Eligibility Criteria

Inclusion Criteria

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

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My prostate cancer has a Gleason score of 7 or less.

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I am 18 years old or older.

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My prostate is estimated to be 80 grams or less in size.

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My prostate cancer is in the early stages and has not spread.

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I can take care of myself and am up and about more than 50% of my waking hours.

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My urinary symptoms are mild without needing strong medication.

POTEN-C Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To compare the decline in patient health-related quality of life.

Secondary outcome measures

Acute & Chronic Genitourinary (GU) and Gastrointestinal (GI) toxicity

Biochemical progression free survival.

Evaluate simplified 'practical' secondary HRQOL sexual potency endpoints.

+3 more

POTEN-C Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SAbR WITH Neurovascular sparingExperimental Treatment1 Intervention

GTV represents MR defined dominant radiographic disease, if identifiable. CTV encompasses the full prostate. At physician's discretion, the insertion of the seminal vesicle upon the prostate on slices containing prostate may be included. PTV1_30Gy represents a 3mm expansion on the CTV, excluding the neurovascular structures on the side to be spared (left or right). PTV1 will receive 6 Gy per fraction for 5 fractions (30 Gy). PTV2_SAbR40Gy OR PTV2_SAbR45Gy will be generated by subtracting a 5mm expansion around the neurovascular elements to be spared (at least one side, left or right) from PTV1. These neurovascular structures consist of the neurovascular bundle, penile bulb, and internal pudendal arteries (see 4.1.5.2.16). PTV2 will receive 8-9 Gy per fraction for 5 fractions (40-45 Gy).

Group II: SAbR WITHOUT Neurovascular sparingActive Control1 Intervention

GTV represents MR defined dominant radiographic disease, if identifiable. CTV encompasses the full prostate. At physician's discretion, the insertion of the seminal vesicle upon the prostate on slices containing prostate may be included. PTV1_30Gy will not be used or created on this arm PTV2_SAbR40Gy OR PTV2_SAbR45Gy will be generated by a 3mm expansion on the CTV. PTV2_SAbR will receive 8-9 Gy per fraction for 5 fractions (40-45 Gy).

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,047 Previous Clinical Trials

1,053,679 Total Patients Enrolled

17 Trials studying Prostate Cancer

2,160 Patients Enrolled for Prostate Cancer

Boston Scientific CorporationIndustry Sponsor

719 Previous Clinical Trials

932,950 Total Patients Enrolled

4 Trials studying Prostate Cancer

748 Patients Enrolled for Prostate Cancer

Media Library

30Gy (Gray) planning target volume (PTV) (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT03525262 — Phase 2

Prostate Cancer Research Study Groups: SAbR WITH Neurovascular sparing, SAbR WITHOUT Neurovascular sparing

Prostate Cancer Clinical Trial 2023: 30Gy (Gray) planning target volume (PTV) Highlights & Side Effects. Trial Name: NCT03525262 — Phase 2

30Gy (Gray) planning target volume (PTV) (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03525262 — Phase 2

Frequently Asked Questions

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

How many individuals can join this research project?

"Yes, the information on clinicaltrials.gov indicates that this clinical trial is currently recruiting participants. The clinical trial was initially posted on 4/24/2018 and was last edited on 6/28/2022. The study is searching for 120 patients across 7 sites."

Answered by AI

Are there different sites where this research is taking place within the city?

"If you are considering participating in this trial, know that there 7 recruitment sites. They are situated in Stony Brook, Cleveland, Ann Arbor and 4 other locations. Selecting the site closest to your residence will reduce travel-related costs."

Answered by AI

What are we trying to learn from this research?

"The sponsor of this clinical trial, Boston Scientific Corporation, intends to measure the primary outcome—a patient's decline in health-related quality of life—over a 24-month period. Additionally, this study will track biochemical failure RTOG-ASTRO definition (also known as Phoenix definition), time to distant recurrence, and evalute simplified 'practical' secondary HRQOL sexual potency endpoints as secondary outcomes."

Answered by AI

What is the maximum dosage of gray matter that has been approved by the FDA?

"Since this is a Phase 2 trial, there is only some data supporting safety for the 30Gy (Gray) planning target volume (PTV). This received a score of 2."

Answered by AI

Are there any available openings for people who want to participate in this clinical trial?

"That is correct, the trial information available on clinicaltrials.gov specifies that recruitment is still underway. This experiment was initially advertised on April 24th, 2018 and has been updated as recently as June 28th, 2022. The researchers running this study are looking to enroll 120 individuals from 7 distinct locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prostate Oncologic Therapy While Ensuring Neurovascular Conservation (POTEN-C)

Neil Desai 2018. "Prostate Oncologic Therapy While Ensuring Neurovascular Conservation (POTEN-C)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03525262.

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