Clinical trial NCT02874014: Hypofractionation Proton Beam Therapy With Concurrent Treatment of Prostate and Pelvic Nodes for Prostate Cancer
Official title: Prospective Evaluation of Hypofractionation Proton Beam Therapy With Concurrent Treatment of the Prostate and Pelvic Nodes for Clinically Localized, High Risk or Unfavorable Intermediate Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-08-22
Enrollment: 56
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is to examine a moderate hypofractionation regimen of proton beam therapy for high risk or unfavorable intermediate risk prostate cancer. The prostate and seminal vesicles are treated with 6750 centigray (RBE) in 25 fractions (i.e. 270 centigray/fraction), while the regional pelvic nodes receive 4500 centigray (RBE) in 25 fractions (i.e. 180 centigray/fraction) simultaneously. The overall treatment time is 5 weeks.

Detailed description: Proton beam therapy can provide a therapeutic gain by offering at least equivalent (or superior) tumor control while reducing the risk of radiation toxicity, in comparison with conventional photon-based external beam radiotherapy, given its dose-deposition characteristics. Currently the clinical target volume of proton beam for the treatment of prostate cancer has been mostly limited to the prostate and the seminal vesicles. There has been no study of proton beam therapy to treat both the primary tumor in the prostate and the regional pelvic nodes simultaneously using a moderate hypofractionation regimen.

The study is a prospective, single-arm, clinical trial to evaluate a moderate hypofractionation regimen of proton beam therapy for high risk or unfavorable intermediate risk prostate cancer. The clinical target volumes of proton beam therapy include both the prostate/seminal vesicles and the regional pelvic nodes. The primary objective is to assess late grade ≥ 3 gastrointestinal (GI) and genitourinary (GU) toxicity. The secondary objectives are to evaluate late grade ≥ 2 GI and GU toxicity, acute grade ≥ 3 GI and GU toxicity, and disease-free survival including freedom from PSA (prostate specific antigen) relapse at 5 years. The study provides an avenue to examine the safety, efficacy, cost effectiveness, and convenience of a moderate hypofractionation regimen (5-week course) of proton beam therapy.

Eligibility criteria: Inclusion Criteria:

* Male; Age ≥ 18 years.
* Histological confirmation of adenocarcinoma of the prostate within 6 months of study enrollment.
* Clinical stage T1-2 N0 M0, Gleason Score 7, Prostate Specific Antigen (PSA) 20-100 ng/mL, or Clinical stage Any T N0 M0, Gleason Score 8-10, PSA ≤ 100 ng/mL, or Clinical stage T3-4 N0 M0, any Gleason Score, PSA ≤ 100 ng/mL, or Clinical stage T1-2 N0 M0, Gleason Score 4+3, PSA 10-20 ng/mL
* Zubrod performance score (PS) ≤ 1
* Total bilirubin, aspartate aminotransferase, alkaline phosphatase, and serum creatinine: \< 2 x upper normal limit
* Signed informed consent.

Exclusion Criteria:

* Any known nodal (N1) or distant metastasis (M1)
* Previous androgen deprivation therapy lasting more than 6 months
* History of inflammatory bowel disease
* Presence of a hip prosthesis
* Prior pelvic radiotherapy or prostatectomy
* Prior or concurrent antineoplastic agents (chemotherapy)
* Previous or concurrent malignancy other than non-melanoma skin cancer within 5 years of diagnosis of prostate cancer.
* Inability to start the protocol treatment within 1 month after study enrollment.
* Medical or psychiatric conditions that preclude informed decision-making or compliance with the protocol treatment or follow-up

Primary outcomes:
measure: Late Grade ≥ 3 Gastrointestinal (GI) and Genitourinary (GU) Toxicity of Interest, Using the CTCAE v4.0
timeFrame: Between 3 months and 24 months post proton beam therapy
Secondary outcomes:
measure: Late Grade ≥ 2 GI and GU Toxicity of Interest, Using the CTCAE v4.0
timeFrame: Between 3 months and 24 months post proton beam therapy
measure: Acute Grade ≥ 3 GI and GU Toxicity of Interest Within 3 Months Post Proton Beam Therapy, Using the CTCAE v4.0
timeFrame: Within 3 months post proton beam therapy
measure: Disease-free Survival Including Freedom From PSA Relapse at 5 Years Post Proton Beam Therapy
timeFrame: 5 years post proton beam therapy
measure: Disease-specific Survival at 5 Years Post Proton Beam Therapy
timeFrame: 5 years post proton beam therapy
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Mark R. Waddle, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Choo R, Hillman DW, Daniels T, Vargas C, Rwigema JC, Corbin K, Keole S, Vora S, Merrell K, Stish B, Pisansky T, Davis B, Amundson A, Wong W. Proton Therapy of Prostate and Pelvic Lymph Nodes for High Risk Prostate Cancer: Acute Toxicity. Int J Part Ther. 2021 Sep 14;8(2):41-50. doi: 10.14338/IJPT-20-00094.1. eCollection 2021 Fall.