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Radiation

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

Phase 2

Waitlist Available

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

Must not have

MRI evidence of gross disease ≤5mm of BOTH neurovascular bundles

Previous pelvic radiotherapy, chemotherapy, or surgery for prostate cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

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

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My MRI shows disease very close to major nerves and blood vessels.

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I have had treatments like radiotherapy, chemotherapy, or surgery for prostate cancer.

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I am currently on hormone therapy for my cancer.

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My cancer has spread to other parts of my body.

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My cancer has spread to the lymph nodes in my pelvis.

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I had prostate surgery or treatment within the last year.

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I have severe problems with urination.

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I do not have severe health issues like heart problems, infections, or uncontrolled bleeding disorders.

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I can feel the disease in the gland where nerve-sparing might be done.

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My prostate cancer has spread beyond the prostate.

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I have been on hormone therapy for prostate cancer for over 3 months.

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

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

Primary study objectives

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

Secondary study objectives

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

Biochemical progression free survival.

Evaluate simplified 'practical' secondary HRQOL sexual potency endpoints.

+3 more

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

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 / 17Eligibility criteria met