Prostate Cancer Postoperative Stereotactic Body Radiotherapy With Adaptive Technology for Minimizing Toxicity
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
- CHRISTY PALODICHUK
- 310-794-2971
- [email protected]
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
Secondary Outcome Measures
Gastrointestinal Domain Score
Sexual Domain Score
Change in IPSS Score
Long-Term Patient Reported GU Symptoms
Long-Term Patient-Reported GI Symptoms
GU and GI Adverse Events
Five-year Cumulative Incidence of GU and GI Adverse Events
Progression-Free Survival
Biochemical Recurrence
Distant Metastasis-Free Survival
Timeline
Last Updated
July 24, 2025Start Date
July 22, 2025Today
November 9, 2025Completion Date ( Estimated )
August 1, 2036
Sponsors of this trial
Lead Sponsor
Jonsson Comprehensive Cancer Center