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

Jonsson Comprehensive Cancer Center

Status: Enrolling

Conditions: Prostate Cancer (CRPC)

Study type: Observational

Funder types: Other

Identifiers

NCT07077239

25-0627

NCI-2025-05089 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

200 participants in 1 patient group

Guided Stereotactic Body Radiotherapy

Description:

Patient who has elected to receive SBRT following prostatectomy: eligibility determination based on PSA, pathology, and/or Decipher score