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

Jonsson Comprehensive Cancer Center200 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Prostate Cancer (CRPC)

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Genitourinary Domain Score

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.

Time frame: 5 years

Secondary Outcomes

Gastrointestinal Domain Score

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.

Time frame: 5 years

Sexual Domain Score

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.

Time frame: 5 years

Change in IPSS Score

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.

Time frame: 5 years

Long-Term Patient Reported GU Symptoms

To quantify long-term patient-reported GU symptoms using the EPIC-26 instrument at 6 month intervals between 24 months and 5 years.

Time frame: 5 years

Long-Term Patient-Reported GI Symptoms

To quantify long-term patient-reported GI symptoms using the EPIC-26 instrument at 6 month intervals between 24 months and 5 years.

Time frame: 5 years

GU and GI Adverse Events

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.

Time frame: 5 years

Five-year Cumulative Incidence of GU and GI Adverse Events

To quantify the five-year cumulative incidence of physician scored GU and GI adverse events using the CTCAE v5.0 scale.

Time frame: 5 years

Progression-Free Survival

quantify five-year progression-free survival.

Time frame: 5 years

Biochemical Recurrence

To quantify 5-year cumulative incidence of biochemical recurrence.

Time frame: 5 Years

Distant Metastasis-Free Survival

To quantify 5-year distant metastasis-free survival.

Time frame: 5 years

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

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts