Hypofractionated Proton Radiation Therapy for Low and Intermediate Risk Prostate Cancer

An Expanded Phase II Study of Hypofractionated Dose Intense Image Guided Proton Radiation Therapy for Low and Intermediate Risk Adenocarcinoma of the Prostate

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01368055

Acronym

PR07

Enrollment

361

Registered

2011-06-07

Start date

2011-09-30

Completion date

2025-08-31

Last updated

2025-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Proton Radiation, Prostate Cancer

Brief summary

The purpose of this trial is to give a shorter course (5 ½-6 weeks) of proton radiation that has as little side effects on normal bladder and rectal tissues as the usual longer course (8 weeks) of proton radiation, without decreasing the chance of killing prostate cancer cells.

Interventions

RADIATION70 Gy/CGE

Low Risk

RADIATION72.5 Gy/CGE

Intermediate Risk

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Prostate cancer. * Gleason score 2-6 or 7. * PSA ≤ 20 ng/ml.

Exclusion criteria

* Previous prostate cancer surgery or pelvic radiation. * Prior/concurrent systemic chemotherapy for prostate cancer. * Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum. * History of hip replacement. * Prior intrapelvic surgery. * Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its uses during radiation. * Receiving continuous and current anticoagulation with Warfarin sodium (Coumadin), Clopidogrel bisulfate (Plavix), dabigatran etexilate mesylate (Pradaxa),enoxaparin sodium (Lovenox), or aspirin/er dipyridamole (Aggrenox).

Design outcomes

Primary

Measure	Time frame
Cumulative incidence of treatment-related grade 2 or higher rectal bleeding.	2 years after completion of radiation therapy

Secondary

Measure	Time frame	Description
Analyzation of quality of life	After radiation: every 6 months for 3 years, then annually for 20 years	—
Analysis of treatment-related morbidity	Cumulative incidence up to 20 years after completion of radiation therapy	—
Analysis of disease control	Cumulative incidence up to 20 years after completion of radiation therapy	Proportion of patients with disease control after completion of treatment
Analysis of overall survival	Cumulative incidence up to 20 years after completion of radiation therapy	Proportion of patients alive after completion of treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026