Prostate Cancer Postoperative Stereotactic Body Radiotherapy With Adaptive Technology for Minimizing Toxicity

Summary

Single-arm, prospective registry study assessing changes in acute patient-reported urinary (GU) and gastrointestinal (GI) quality of life at the 24-month post-treatment time point following magnetic resonance imaging (MRI)-guided or computed tomography (CT)-guided stereotactic body radiotherapy (SBRT) delivered to the prostate bed +/- pelvic lymph nodes. The decision to offer an adaptive treatment will be at the clinician's discretion.

Eligibility

Inclusion Criteria

* History of histologically confirmed, clinical localized adenocarcinoma of the prostate treated with radical prostatectomy with definitive intent.
* Presence of any ONE of the following:

  1. Adverse pathologic features at the time of prostatectomy (positive surgical margin, pathologic T-stage 3-4 disease, pathologic Gleason score 8-10 disease, OR presence of tertiary Gleason grade 5 disease)
  2. Documentation of rising prostate-specific antigen on at least two consecutive draws, with the magnitude of prostate-specific antigen exceeding 0.03 ng/mL
  3. Intermediate- or high-risk Decipher genomic classifier score
  4. Identification of prostate cancer in ≥1 lymph node at the time of prostatectomy (pN+ disease)
* CT scan and MRI of the pelvis within 120 days prior to enrollment \[note: (a) if patient has medical contraindication to MRI, an exemption will be granted and enrollment can proceed; (b) for patients with PSA \<1.0 ng/mL, the treatment planning CT can substitute for a diagnostic CT scan; (c) a low-field, radiation planning MRI can replace the diagnostic MRI if the patient refuses or cannot obtain a high-field MRI\].
* Bone scan OR advanced nuclear imaging study within 120 days prior to enrollment for patients with PSA \>1.0 ng/mL.
* Age ≥ 18.

  \~. KPS ≥ 70 and/or ECOG \<2.
* Ability to understand, and willingness to sign, the written informed consent

Exclusion Criteria

* Patients with any evidence of distant metastases. Note, evidence of lymphadenopathy below the level of the renal arteries can be deemed loco regional per the discretion of the investigator.

  * Patients with neuroendocrine or small cell carcinoma of the prostate
  * Prior pelvic radiotherapy
* History of Crohn's Disease, Ulcerative Colitis, or Ataxia Telangiectasia

Conditions2

Locations1 site

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