Prostate Adenocarcinoma, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8
Conditions
Brief summary
This phase II trial tests whether magnetic resonance imaging (MRI)-guided hypofractionated radiation therapy works to reduce treatment time and side effects in patients with high risk prostate cancer. MRI-guided hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time directly to diseased tissue, reducing damage to healthy tissue. Using MRI-guided radiation therapy on areas of the prostate and pelvic lymph nodes may shorten overall treatment time compared to the longer standard of care therapy and may reduce the number and/or duration of side effects.
Detailed description
PRIMARY OBJECTIVE: I. Evaluate late grade 2+ genitourinary (GU) toxicity. SECONDARY OBJECTIVE: I. Evaluating acute GU and gastrointestinal (GI) toxicity, late GI toxicity, overall survival, prostate cancer specific survival, biochemical failure, and quality of life. OUTLINE: Patients undergo MRI-guided intensity-modulated radiation therapy (IMRT) on study and receive standard of care (SOC) antiandrogen therapy (ADT) throughout the trial. Patients may also undergo prostate specific membrane antigen (PSMA) positron emission tomography (PET), computed tomography (CT), MRI, and bone scans at screening and undergo collection of blood samples throughout the trial. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for a total of 4 years.
Interventions
PROCEDUREMRI-guided Intensity-Modulated Radiation Therapy
Undergo MRI-guided IMRT
Receive SOC ADT
PROCEDUREPSMA PET Scan
Undergo PSMA PET scan
PROCEDUREComputed Tomography
Undergo CT
PROCEDUREMagnetic Resonance Imaging
Undergo MRI
PROCEDUREBone Scan
Undergo bone scan
PROCEDUREBiospecimen Collection
Undergo blood sample collection
OTHERQuality-of-Life Assessment
Ancillary studies
Sponsors
Thomas Jefferson University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age: above 18 years * Participants must be histologically proven, adenocarcinoma prostate * Localized to the prostate without positive pelvic lymph node involvement * No distant metastatic disease assessed by pretreatment PSMA PET or bone scan and CT scan * High risk prostate cancer as defined by National Comprehensive Cancer Network (NCCN): Gleason score of 8- 10, clinical stage T3a or higher, or prostate specific antigen (PSA) \> 20 ng/mL * Ability to receive long term hormone therapy * Karnofsky performance score (KPS) \> 70 * No prior history of therapeutic irradiation to pelvis * Patient willing and reliable for follow-up and quality of life (QOL) * English speaking/reading
Exclusion criteria
* Evidence of distant or pelvic metastasis at any time since presentation * Life expectancy \< 2 years * Previous radiation therapy (RT) to prostate or prostatectomy * A previous trans-urethral resection of the prostate (TURP) * Severe urinary symptoms or with severe International Prostate Symptom Score (IPSS) score despite being on hormonal therapy for 6 months which in the opinion of the physician precludes RT * Patients with known obstructive symptoms with stricture * Any contraindication to radiotherapy such as inflammatory bowel disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of late grade 2+ genitourinary (GU) toxicity | At 1 year | Per Common Terminology Criteria for Adverse Events version 5.0 compared to rate of toxicity in POP-RT trial. Will be estimated for the entire sample that receives the intervention, treating death from any cause (other than treatment) as a competing risk and censoring subjects who drop out before experiencing toxicity at time of last follow-up. A point estimate of cumulative incidence at 1 year will be estimated from this curve along with a two-sided 90% confidence interval. If the upper bound of the interval is less than 20%, the null hypothesis will be rejected. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of acute GU and gastrointestinal (GI) toxicity | At baseline | Will be estimated using a binomial proportion and exact 95% confidence interval. |
| Incidence of late GI toxicity | At baseline | Will be estimated using a binomial proportion and exact 95% confidence interval. |
| Overall survival | At baseline | Will be estimated using the Kaplan-Meier method. |
| Prostate cancer specific survival | At baseline | Will be estimated using the Kaplan-Meier method. |
| Biochemical failure | At baseline | Defined as prostate specific antigen nadir plus 2 ng/ml. Will be estimated using the Kaplan-Meier method. |
| Quality of life measurement | At baseline | Using patient reported outcome-expanded prostate cancer index composite. Will be summarized using descriptive statistics. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJessie DiNome, MD
Thomas Jefferson University
Outcome results
None listed