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PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Recurrent Prostate Cancer

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment54 people
  • Recruiting US sites1
  • SponsorUniversity of Nebraska
  • RegistryNCT07234981

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Recurrent Prostate Cancer: a one-minute explainerNCT072349811 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age30 Years to no maximum
  • SexMale
  • Healthy volunteersNo

You may be able to join if

  • Prior biopsy proven prostate cancer for which they underwent a radical prostatectomy with curative intent.
  • Evidence of biochemical recurrence as defined by NCCN: Persistent positive PSA post-radical prostatectomy (RP) or an undetectable PSA after RP with a subsequent detectable PSA that increases on ≥2 determinations (PSA recurrence) or increases to PSA >0.1 ng/mL.
  • Targetable PSMA-avid lesion within the prostate bed, pelvic lymph nodes, or both and/or targetable lesion in prostate bed defined on MRI suspicious for local recurrence.
  • If lesions are amenable for biopsy this may be attempted, but biopsy proven recurrence/persistence is not required for trial enrollment.
  • Life expectancy greater than 5 years.
  • Karnofsky performance status ≥ 80 or Eastern Cooperative Oncology Group performance status ≤ 2 within 14 days prior to registration.
  • Age ≥ 30 years.
  • Patient must be able to provide study-specific informed consent prior to study entry.

You cannot join if

  • Evidence of distant metastatic disease outside the pelvic lymph nodes (including osseous pelvic disease).
  • Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse.
  • Relative or absolute contraindications to radiation therapy as determined by the treating physician. These include but are not limited to inflammatory bowel disease, connective tissue disorders (systemic lupus erythematosus, scleroderma, etc.), and genetic disorders that risk increased sensitivity to radiation therapy.

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

  • PSMA-guided Salvage Radiation (Radiation): External beam radiation therapy will consist of 45 Gy delivered in 25 daily fractions, followed by a sequential boost to PET-avid disease to 63-70.2 Gy in an additional 10-14 fractions.

The study

Treatment groups

Na · Single Group · masking: None

De-escalated PSMA-guided salvage radiation (Experimental)

Enrolled patients will receive an MRI and PSMA-PET/CT scan to identify locations of disease. The intervention will involve salvage radiation therapy to the prostate bed, pelvis, and pelvic nodes as indicated by imaging. External beam radiation therapy will consist of 45 Gy delivered in 25 daily fractions, followed by a sequential boost to PET-avid disease to 63-70.2 Gy in an additional 10-14 fractions.

What it involves

Procedures

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

  • CT scans: Part of the study plan
  • MRI: Part of the study plan
  • PET scans: Part of the study plan
  • radiation: Part of the study plan

Goals

What the study measures

Main goals

  • Grade 2+ acute toxicity occurence (4 months)

Other goals

  • Occurrence of biochemical progression-free survival
  • Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
  • Overall Survival
  • Comparison of patient reported outcomes pre-, during follow-up, and post-study using the IPSS (International Prostate Symptom Score)

Planned enrollment: 54 (estimated).

Where

Recruiting US sites

  • University of Nebraska Medical Center, Omaha, Nebraska

Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Sep 20, 2026. Public record; not medical advice.

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