Prostate Cancer (CRPC)
Conditions
Keywords
prostatectomy
Brief 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.
Interventions
None listed
Sponsors
Jonsson Comprehensive Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Genitourinary Domain Score | 5 years | To determine the rate of 2x MCID changes in any genitourinary domain score of the patient-reported EPIC-26 QOL tool at any point between the start of treatment and 24-months following CT-guided or MRI-guided adaptive stereotactic body radiotherapy (SBRT) to the prostate bed and/or pelvic lymph nodes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal Domain Score | 5 years | To determine the rate of 2x MCID changes in any gastrointestinal domain score of the patient-reported EPIC-26 QOL tool at any point between baseline and 24 months following CT-guided or MRI-guided adaptive stereotactic body radiotherapy (SBRT) to the prostate bed and/or pelvic lymph nodes, with a comparison to historical control data for non-adaptive post-prostatectomy SBRT regimens. |
| Sexual Domain Score | 5 years | To determine the rate of 2x MCID changes in any sexual domain score of the patient-reported EPIC-26 QOL tool at any point between the start of treatment and 24-months following CT-guided or MRI-guided adaptive stereotactic body radiotherapy (SBRT) to the prostate bed and/or pelvic lymph nodes, with a comparison to historical control data for non-adaptive post-prostatectomy SBRT regimens. |
| Change in IPSS Score | 5 years | To quantify changes in IPSS score at 3 month intervals within the first 12 months of treatment, then at 6 month intervals thereafter until 5 years. |
| Long-Term Patient Reported GU Symptoms | 5 years | To quantify long-term patient-reported GU symptoms using the EPIC-26 instrument at 6 month intervals between 24 months and 5 years. |
| Long-Term Patient-Reported GI Symptoms | 5 years | To quantify long-term patient-reported GI symptoms using the EPIC-26 instrument at 6 month intervals between 24 months and 5 years. |
| GU and GI Adverse Events | 5 years | To quantify rates and severity of acute physician scored GU and GI adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v. 5.0) scale. |
| Five-year Cumulative Incidence of GU and GI Adverse Events | 5 years | To quantify the five-year cumulative incidence of physician scored GU and GI adverse events using the CTCAE v5.0 scale. |
| Progression-Free Survival | 5 years | quantify five-year progression-free survival. |
| Biochemical Recurrence | 5 Years | To quantify 5-year cumulative incidence of biochemical recurrence. |
| Distant Metastasis-Free Survival | 5 years | To quantify 5-year distant metastasis-free survival. |
Countries
United States
Contacts
CONTACTCHRISTY PALODICHUK
PRINCIPAL_INVESTIGATORLuca Valle, MD
University of California at Los Angeles
Outcome results
None listed