Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at Los Angeles, California
Dates
study started
study ends around
Principal Investigator
by Luca F. Valle, MD
Headshot of Luca F. Valle
Luca F. Valle

Description

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.

Official Title

MAgnetic Resonance Imaging or Computed Tomography Guided Stereotactic Body Radiotherapy With Online Adaptive Technology for Minimizing Toxicity During Salvage or AdjUvaNt Radiotherapy for ProstatE Cancer (MASAMUNE)

Details

This project is a single-arm, prospective 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. There is no pre-specified target enrollment for patients undergoing standard non-adaptive SBRT. The target enrollment of patients undergoing adaptive treatment is 200 patients. The rate of accrual is expected to be in the range of 40 patients per year.

Keywords

Prostate Cancer (CRPC), prostatectomy, Prostatic Neoplasms, Guided Stereotactic Body Radiotherapy

Eligibility

You can join if…

Open to males ages 18 years and up

  • 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

You CAN'T join if...

  • 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.
  • History of Crohn's Disease, Ulcerative Colitis, or Ataxia Telangiectasia

Location

  • University of California at Los Angeles accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at UCLA

  • Luca F. Valle, MD
    HS Assistant Clinical Professor, Radiation Oncology, Medicine. Authored (or co-authored) 71 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Jonsson Comprehensive Cancer Center
Links
Sign up for this study
ID
NCT07077239
Study Type
Observational [Patient Registry]
Participants
Expecting 200 study participants
Last Updated