RecruitingPhase not listed

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

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)

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
  • "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."
  • "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."
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 follows people who get focused radiation after surgery to remove the prostate for prostate cancer. It looks at patient-reported bladder, bowel, and quality-of-life changes 24 months after treatment. MRI or CT scans guide the radiation, and the doctor decides whether to adjust the treatment plan.

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.

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

Eligibility

Who can join

  • Age 18 or older.
  • Had prostate adenocarcinoma, confirmed by a tissue test, that was considered localized before surgery to remove the prostate with the goal of curing it.
  • Must have at least one risk sign: cancer at the edge of removed tissue; stage T3–T4 cancer; Gleason score 8–10 or a small amount of grade 5 cancer; PSA rising on at least two blood tests and above 0.03 ng/mL; a medium- or high-risk Decipher gene test score; or cancer in at least one lymph node at surgery.
  • Had pelvic CT and MRI scans within 120 days before joining. MRI may be waived if it is unsafe. Certain treatment-planning scans may replace these scans.
  • If PSA is above 1.0 ng/mL, had a bone scan or advanced nuclear imaging scan within 120 days before joining.
  • Meets daily activity score requirements: KPS at least 70 and/or ECOG below 2. These scores measure how well you can do daily tasks.
  • Can understand the study and is willing to sign a consent form.

Who can't join

  • Cancer has spread to distant parts of the body. The study doctor may count enlarged lymph nodes below the kidney arteries as nearby, rather than distant, disease.
  • Has neuroendocrine or small cell prostate cancer, which are specific types of prostate cancer.
  • Had radiation treatment to the pelvis before.
  • Has a history of Crohn’s disease or ulcerative colitis, which cause bowel swelling, or ataxia telangiectasia, an inherited condition.

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

Official eligibility criteria

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

Study sites (1)

CA