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

Clinicaltrials.gov ID: NCT07077239
db-list-check Status RECRUITING
b-loader Phase
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 200

Conditions

Prostate Cancer (CRPC)

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.

Detailed 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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Luca Valle, MD

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 Plan

Guided Stereotactic Body Radiotherapy

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

Outcome Measures

Primary Outcome Measures

Genitourinary Domain Score

Time Frame: 5 years

Secondary Outcome Measures

Gastrointestinal Domain Score

Time Frame: 5 years

Sexual Domain Score

Time Frame: 5 years

Change in IPSS Score

Time Frame: 5 years

Long-Term Patient Reported GU Symptoms

Time Frame: 5 years

Long-Term Patient-Reported GI Symptoms

Time Frame: 5 years

GU and GI Adverse Events

Time Frame: 5 years

Five-year Cumulative Incidence of GU and GI Adverse Events

Time Frame: 5 years

Progression-Free Survival

Time Frame: 5 years

Biochemical Recurrence

Time Frame: 5 Years

Distant Metastasis-Free Survival

Time Frame: 5 years

Timeline

  • Last Updated
    July 24, 2025
  • Start Date
    July 22, 2025
  • Today
    November 9, 2025
  • Completion Date ( Estimated )
    August 1, 2036

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