Phase II Study on PSA Response-Based Treatment and Nodal Coverage for Early Salvage Radiotherapy in Prostate Cancer

Sponsor: University of Texas Southwestern Medical Center

Sponsor score: 40

ClinicalTrials ID:NCT07313241

Provider View

This study is testing a new approach to radiotherapy for prostate cancer patients who have had surgery but still show signs of cancer. It aims to see if adjusting treatment based on PSA levels can be as effective as traditional methods, while reducing unnecessary side effects.

Patient Parameters

Program Overview

This Phase II study is exploring a new method of delivering radiotherapy to prostate cancer patients who have undergone surgery but still have rising PSA levels, indicating potential cancer recurrence. All participants will receive a type of radiotherapy called hypo-fractionated stereotactic radiotherapy to the prostate area. After 5 weeks, their PSA levels will be checked. If the PSA levels have dropped significantly, patients will be monitored without further immediate treatment. If not, they will receive additional radiotherapy to the pelvic area and a 4-month course of hormone therapy. The study aims to find out if this tailored approach can keep cancer from progressing for two years, as effectively as traditional methods that use more extensive treatment for all patients.

Description

After prostate surgery, some men experience a rise in PSA levels, suggesting that cancer might still be present even if it can't be seen on scans. The usual treatment involves radiotherapy and hormone therapy, which can have side effects. This study is testing a new strategy where radiotherapy is given in a focused way to the prostate area. After 5 weeks, if PSA levels drop below 0.05 ng/mL or decrease by 0.2 ng/mL from before treatment, patients will be observed without further immediate treatment. If PSA levels don't drop enough, patients will receive additional radiotherapy to the pelvic area and 4 months of hormone therapy. The main goal is to see if this approach can keep cancer from progressing for two years, as effectively as traditional methods. The study will also look at side effects related to hormones, urinary, and bowel functions, as well as any gastrointestinal or urinary issues reported by doctors. This approach could reduce unnecessary side effects for those who respond well to initial treatment, while providing more intensive treatment for those who need it.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 years or older with confirmed prostate cancer treated with surgery within the last 10 years, and a PSA level of 0.05 ng/mL or higher after surgery.
  • Surgery must have been done at least 4 months before joining the study, with no cancer found in lymph nodes.
  • Good overall health with an ECOG performance status of 0 to 2.
  • No clear signs of cancer spread to other areas, based on scans done within 90 days before joining the study. If PSA is 0.2 ng/mL or higher, a PET scan with a special imaging agent is required. If PSA is below 0.2 ng/mL, a PET scan or a CT/MRI scan is needed.
  • Men who are sexually active must agree to use effective birth control during the study and for 60 days after.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Previous hormone therapy for more than 3 months or anti-androgen therapy for more than 30 days. If shorter, a 30-day break is needed with testosterone levels back to normal.
  • Currently on testosterone replacement therapy and unwilling to stop.
  • Previous radiotherapy to the pelvic area.
  • Uncontrolled health issues like ongoing infections, heart problems, or psychiatric conditions that could affect participation.
  • History of bladder or urethral issues needing treatment.
  • Other cancers that could interfere with this study.
  • Active inflammatory bowel disease needing ongoing treatment.

Locations

FACILITYZIPCITYSTATE
UT Southwestern Medical Center-Dallas75390DallasTexas

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