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SURPASS: Stereotactic Ultra-hypofractionated Radiotherapy for Post-prostatectomy Patients: Adaptive Salvage SBRT

A Phase Ib Single-Arm Study Evaluating Toxicity, Outcomes, and Dosimetry Using Adaptive Stereotactic Body Radiotherapy for the Salvage Treatment of Post-prostatectomy Prostate Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans, CT scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Patients will have a computed tomography (CT) or Magnetic resonance imaging (MRI) simulation visit as part of the standard of care (SOC), which will be used for treatment planning."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether focused radiation called SBRT, adjusted each day, is safe and practical after surgery to remove the prostate. It is for men who need radiation to the area where the prostate was because of signs that cancer may remain or return.

The purpose of the study is to evaluate the safety and feasibility of daily-adaptive post-prostatectomy stereotactic body radiotherapy (SBRT) to the prostate fossa in men undergoing salvage radiotherapy after radical prostatectomy.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older.
  • A tissue test confirmed prostate adenocarcinoma, a type of prostate cancer, and you have had surgery to remove your prostate.
  • You are a candidate for radiation after surgery because of PSA blood test results or cancer features that raise the risk of cancer returning.
  • Qualifying PSA results include PSA that never became undetectable, or PSA that became detectable again and rose on more than 2 tests or rose above 0.1 ng/ml.
  • Qualifying cancer features include cancer at the edge of removed tissue, certain high stage or grade scores, or a medium- or high-risk Decipher gene test result.
  • There is no sign that the cancer has spread to distant parts of the body.
  • You can care for yourself and are up and about for at least half of your waking hours, even if you cannot work.
  • You can complete questionnaires about urinary symptoms and quality of life and give informed consent to join.

Who can't join

  • Your cancer has spread to distant parts of the body.
  • Your cancer is a neuroendocrine or small cell type.
  • You had radiation to the pelvis before, and your radiation doctor believes more radiation would be unsafe.
  • You have inflammatory bowel disease, active scleroderma, lupus, or another rheumatic disease, and your radiation doctor believes radiation would be unsafe. These diseases can affect the bowel, skin, joints, or other body tissues.
  • You have a known mental health or substance use disorder that would keep you from following the study requirements.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Patients at or over 18 years old. 2. Have a histologically confirmed diagnosis of prostate adenocarcinoma status post radical prostatectomy who are candidates for salvage postoperative radiotherapy. This includes patients whose Prostate-Specific Antigen (PSA) does not fall to undetectable levels after prostatectomy or that have undetectable PSA after prostatectomy with a subsequent detectable PSA that increases on \> 2 determinations or increases to PSA \> 0.1 ng/ml. It also includes patients with adverse pathologic features at the time of prostatectomy (e.g. positive surgical margin, pathologic T-stage 3-4 disease, pathologic Gleason score 8-10 disease, presence of tertiary Gleason grade 5 disease) or an intermediate- or high-risk Decipher genomic classifier score. 3. No evidence of metastatic disease 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 5. Can complete EPIC-26/IPSS assessments and provide informed consent Exclusion Criteria: 1. Distant metastatic disease 2. Neuroendocrine or small cell histology 3. Prior pelvic radiotherapy which in the opinion of the treating radiation oncologist precludes safe radiation therapy. 4. Has a diagnosis of inflammatory bowel disease, active scleroderma, lupus, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe radiation therapy. 5. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

Study sites (1)

NY