PR04: Proton Therapy for Low and Intermediate Risk Prostate Cancer

Sponsor
University of Florida (Other)
Overall Status
Completed
CT.gov ID
NCT00693238
Collaborator
(none)
228
1
2
168.8
1.4

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Radiation: Low Risk Proton Radiation
  • Radiation: Intermediate Risk Proton Radiation
N/A

Detailed Description

Low Risk - Total of 70 Gy/CGE over 28 treatments

Intermediate Risk - Total of 72.5 Gy/CGE over 29 treatments

Study Design

Study Type:
Interventional
Actual Enrollment :
228 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of Hypofractionated Image Guided Proton Radiation Therapy for Low and Intermediate Risk Adenocarcinoma of the Prostate
Study Start Date :
Apr 1, 2008
Actual Primary Completion Date :
Jun 1, 2012
Actual Study Completion Date :
Apr 25, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Low Risk Proton Radiation

70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx

Radiation: Low Risk Proton Radiation

Experimental: Intermediate Risk Proton Radiation

72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx

Radiation: Intermediate Risk Proton Radiation

Outcome Measures

Primary Outcome Measures

  1. Acute Grade 3 (NCI CTC v4.0) or Higher Treatment-related Toxicity Rate. [6 months after the end of radiation therapy]

Secondary Outcome Measures

  1. Disease Control [20 years after end of radiation]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No

Inclusion Criteria

  • Prostate cancer.

  • Gleason score 2-7.

  • PSA ≤ 20 ng/ml.

Exclusion Criteria:
  • Previous prostate cancer surgery or pelvic radiation.

  • Prior or current chemotherapy for prostate cancer.

  • Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum.

  • History of proximal urethral stricture requiring dilatation.

  • History of hip replacement.

  • Diabetes requiring medication.

  • Prior intrapelvic surgery.

  • Current and continuing anticoagulation with Warfarin sodium (Coumadin), Clopidogrel bisulfate (Plavix), enoxaparin sodium (Lovenox), or aspirin/er dipyridamole (Aggrenox).

  • On Flomax (Tamsulosin), Hytrin (Terazosin) or Cardura (Doxazosin), Uroxatral (alfuzosin HCl).

  • Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Florida Proton Therapy Institute Jacksonville Florida United States 32206

Sponsors and Collaborators

  • University of Florida

Investigators

  • Principal Investigator: Randal H Henderson, MD, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Florida
ClinicalTrials.gov Identifier:
NCT00693238
Other Study ID Numbers:
  • UFPTI 0702-PR04
  • IRB201701653
  • UFJ 2008-022
First Posted:
Jun 6, 2008
Last Update Posted:
Jun 22, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Florida
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details University of Florida Proton Therapy Institute, between 04/2008 and 04/2010
Pre-assignment Detail
Arm/Group Title Low Risk Proton Radiation Intermediate Risk Proton Radiation
Arm/Group Description 70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx 72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx
Period Title: Overall Study
STARTED 122 106
COMPLETED 122 106
NOT COMPLETED 0 0

Baseline Characteristics

Arm/Group Title Low Risk Proton Radiation Intermediate Risk Proton Radiation Total
Arm/Group Description 70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx 72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx Total of all reporting groups
Overall Participants 122 106 228
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
Between 18 and 65 years
60
49.2%
44
41.5%
104
45.6%
>=65 years
62
50.8%
62
58.5%
124
54.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
65.3
(7.5)
64.1
(6.9)
64.7
(7.2)
Sex: Female, Male (Count of Participants)
Female
0
0%
0
0%
0
0%
Male
122
100%
106
100%
228
100%
Region of Enrollment (participants) [Number]
United States
122
100%
106
100%
228
100%

Outcome Measures

1. Primary Outcome
Title Acute Grade 3 (NCI CTC v4.0) or Higher Treatment-related Toxicity Rate.
Description
Time Frame 6 months after the end of radiation therapy

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Low Risk Proton Radiation Intermediate Risk Proton Radiation
Arm/Group Description 70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx 72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx
Measure Participants 122 106
Number [Participants]
0
0%
0
0%
2. Secondary Outcome
Title Disease Control
Description
Time Frame 20 years after end of radiation

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description

Adverse Events

Time Frame These serious events cover the range from during treatment to the maximum available follow-up for any given patient (current maximum of 4.5 years).
Adverse Event Reporting Description
Arm/Group Title Low Risk Proton Radiation Intermediate Risk Proton Radiation
Arm/Group Description 70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx 72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx
All Cause Mortality
Low Risk Proton Radiation Intermediate Risk Proton Radiation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN)
Serious Adverse Events
Low Risk Proton Radiation Intermediate Risk Proton Radiation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 2/122 (1.6%) 2/106 (1.9%)
Gastrointestinal disorders
Rectal hemmorhage (grade 3) 0/122 (0%) 0 1/106 (0.9%) 1
Proctitis (grade 3) 0/122 (0%) 0 1/106 (0.9%) 1
Renal and urinary disorders
Urinary retention (grade 3) 1/122 (0.8%) 1 0/106 (0%) 0
Hematuria (grade 3) 1/122 (0.8%) 1 0/106 (0%) 0
Other (Not Including Serious) Adverse Events
Low Risk Proton Radiation Intermediate Risk Proton Radiation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 26/122 (21.3%) 21/106 (19.8%)
Gastrointestinal disorders
Rectal hemmorhage 12/122 (9.8%) 12 14/106 (13.2%) 14
Renal and urinary disorders
Urinary Frequency/urgency 22/122 (18%) 22 11/106 (10.4%) 11

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Randal Henderson, MD, MBA
Organization University of Florida
Phone 904-588-1800
Email rhenderson@floridaproton.org
Responsible Party:
University of Florida
ClinicalTrials.gov Identifier:
NCT00693238
Other Study ID Numbers:
  • UFPTI 0702-PR04
  • IRB201701653
  • UFJ 2008-022
First Posted:
Jun 6, 2008
Last Update Posted:
Jun 22, 2022
Last Verified:
Jun 1, 2022