Phase 2
Completed N=56
Hypofractionation Proton Beam Therapy With Concurrent Treatment of Prostate and Pelvic Nodes for Prostate Cancer
Source: ClinicalTrials.gov NCT02874014 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcomePrimary: Late Grade ≥ 3 Gastrointestinal (GI) and Genitourinary (GU) Toxicity of Interest, Using the CTCAE v4.0 — 1; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Late Grade ≥ 3 Gastrointestinal (GI) and Genitourinary (GU) Toxicity of Interest, Using the CTCAE v4.0 |
1; 0 | — |
| SECONDARY Late Grade ≥ 2 GI and GU Toxicity of Interest, Using the CTCAE v4.0 |
6; 19 | — |
| SECONDARY Acute Grade ≥ 3 GI and GU Toxicity of Interest Within 3 Months Post Proton Beam Therapy, Using the CTCAE v4.0 |
0; 0 | — |
| SECONDARY Disease-free Survival Including Freedom From PSA Relapse at 5 Years Post Proton Beam Therapy |
90 | — |
| SECONDARY Disease-specific Survival at 5 Years Post Proton Beam Therapy |
89 | — |
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
Data sourced from ClinicalTrials.gov (NCT02874014). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.