Prostate Cancer
Conditions
Brief summary
This is a phase II study of ultrahypofractionated whole pelvis proton therapy with brachytherapy boost for patients with high risk or unfavorable intermediate risk prostate with elevated risk of lymph node involvement.
Interventions
RADIATIONHypofractionated Whole Pelvis Proton Therapy with Brachytherapy Boost
Brachytherapy boost will be delivered and then whole pelvis proton radiation therapy in 5 fractions.
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathologic evidence of prostate cancer * Risk group: high or intermediate risk as defined below * High risk: T3a or Gleason Grade Group 4/5 or PSA \>20 * Unfavorable intermediate risk disease: at least one or more of the following: T2b-T2c, Gleason Grade Group 2/3, PSA 10-20, \>50% of cores positive * Must be appropriate for whole pelvis per the treating oncologist or based on lymph node predicting nomogram * Patient is a candidate for definitive external beam radiotherapy: * No prior radiotherapy in the region of study * No inflammatory bowel disease, active collagen/vascular/connective tissue disorders * Age ³18 years * ECOG performance status: 0-2 * Patients may initiate androgen deprivation therapy up to 3 months prior to radiation start, concurrently, or up to 3 months after completion of radiation therapy start. Patients may have received androgen deprivation therapy for the following months: unfavorable intermediate risk patients for 6 months; high-risk patients for 24 months. Patients will be allowed to discontinue ADT at physician and patient discretion. * Pretreatment evaluation * History \& Physical by a radiation oncologist within 6 weeks of enrollment * MRI prostate * PSMA PET * PSA level * Eligible for rectal spacer procedure as determined by treating physician * Informed consent: Patients must have the ability to understand and be willing to sign the study-specific informed consent indicating their understanding of the investigational nature and the risks of this study before any of the protocol related studies are performed (this does not include routine laboratory testing or imaging studies required to establish study eligibility);
Exclusion criteria
* Evidence of distant metastatic disease * History of inflammatory bowel or active collagen/vascular/connective tissue disorders * Prior radiation to the pelvis * Prior or concurrent second invasive malignancy other than non-melanoma skin cancers, unless disease free for minimum of five years * Known severe, active co-morbidity, defined as follows: o Any clinically significant unrelated systemic illness, medical condition, or other factor, which at the discretion of the Principal Investigators, would interfere in the safe and timely completion of study procedures, compromise the patient's ability to tolerate the protocol therapy, or is likely to interfere with the study procedures or results. * Patients should not have a prior history of TURP * Patients should not have pre-treatment IPSS \>20 or on maximum alpha-blocker medications at baseline * Patients should not be on therapeutic anticoagulation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of ultrahypofractionated proton therapy with HDR brachytherapy boost | First year of treatment | The technique will be deemed safe if \<10% of patients experience a CTCAE version 5.0 grade 3 or higher genitourinary or gastrointestinal toxicity cumulatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life before and after radiotherapy | First year of treatment | To evaluate for multiple domains of quality of life before and after radiotherapy by using validated surveys including EPIC-26 in urinary continence, urinary obstruction, bowel, and sexual domains. Investigators will determine minimally important differences for each domain. |
| Efficacy of proton radiotherapy | First year of treatment | To determine treatment efficacy of proton radiotherapy for all enrolled patients as evidenced by biochemical control in the months following radiation. Investigators will follow PSA to determine if there is evidence for biochemical recurrence following radiotherapy. PSA recurrence will be defined as an increase of 2 ng/ml higher than the nadir value following completion of radiotherapy. |
Countries
United States
Contacts
CONTACTProject Manager
PRINCIPAL_INVESTIGATORArun Goel, MD
University of Pennsylvania
Outcome results
None listed