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PR05: Docetaxel, Androgen Deprivation and Proton Therapy for High Risk Prostate Cancer

Sponsor
University of Florida (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01040624
Collaborator
(none)
77
Enrollment
1
Location
2
Arms
301
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to see what effects, good and/or bad, proton based radiation combined with low dose chemotherapy and hormonal therapy, has on patients and their cancer.

Condition or Disease Intervention/Treatment Phase
  • Radiation: < 15% risk of + LN
  • Radiation: > 15% risk of + LN
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
77 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of Proton-Based Radiation Therapy With Elective Pelvic Nodal Irradiation, Concomitant Docetaxel, and Adjuvant Androgen Deprivation for High-Risk Prostate Adenocarcinoma
Study Start Date :
Dec 1, 2009
Actual Primary Completion Date :
Jan 1, 2015
Anticipated Study Completion Date :
Jan 1, 2035

Arms and Interventions

Arm Intervention/Treatment
Experimental: High-risk arm A (HR-A)

< 15% risk of + lymph nodes (LN)

Radiation: < 15% risk of + LN
Total of 54 Cobalt gray equivalent (CGE) over 30 treatments to prostate + seminal vesicles (SV), then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during radiation therapy (RT) followed by androgen deprivation therapy for 6 months.
Experimental: HR-B

> 15% risk of + LN

Radiation: > 15% risk of + LN
Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months.

Outcome Measures

Primary Outcome Measures

  1. Acute Grade 3 or Higher Treatment-related Toxicity Rate. [6 months after the completion of radiation therapy]

    Number of participants that experienced acute grade 3 or higher, treatment-related toxicity based on CTCAE version 3.0 criteria.

Secondary Outcome Measures

  1. Collect and Analyze Quality of Life, Treatment-related Late Morbidity, Disease Control, and Survival Outcome Parameters. [After radiation: every 6 months for 3 years, then annually for 20 years]

  2. Collect and Analyze Treatment, Biologic and Diagnostic Information That May Impact Quality of Life, Disease Control, Morbidity and/or Survival Outcomes. [After radiation: every 6 months for 3 years, then annually for 20 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Adenocarcinoma of the prostate.
Exclusion Criteria:

  • Previous prostate cancer treatment such as chemotherapy and/or pelvic radiation.

  • Active inflammatory bowel disease (diverticulitis, Crohn's disease or ulcerative colitis) affecting the rectum. (Non-active diverticulitis and Crohn's disease not affecting the rectum are allowed.)

  • History of hip replacement.

  • Prior intrapelvic surgery. This includes the following:

  • Transrectal or rectal surgery other than polypectomy or hemorrhoid removal or banding

  • Transabdominal pelvic surgery

  • Bladder surgery

  • Prior myocardial infarction (MI) or congestive heart failure (CHF).

  • 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: Nancy P Mendenhall, MD, University of Florida Proton Therapy Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Florida
ClinicalTrials.gov Identifier:
NCT01040624
Other Study ID Numbers:
  • UFPTI 0703 - PR05
  • IRB201702459
First Posted:
Dec 29, 2009
Last Update Posted:
Dec 3, 2021
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Florida
Prostate Cancer, Proton Radiation
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title HR-A HR-B
Arm/Group Description < 15% risk of + lymph nodes (LN) < 15% risk of + LN: Total of 54 Cobalt gray equivalent (CGE) over 30 treatments to prostate + seminal vesicles (SV), then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during radiation therapy (RT) followed by androgen deprivation therapy for 6 months. > 15% risk of + LN > 15% risk of + LN: Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months.
Period Title: Overall Study
STARTED 58 19
COMPLETED 58 19
NOT COMPLETED 0 0

Baseline Characteristics

Arm/Group Title HR-A HR-B Total
Arm/Group Description < 15% risk of + LN < 15% risk of + LN: Total of 54 CGE over 30 treatments to prostate + SV, then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months. > 15% risk of + LN > 15% risk of + LN: Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months. Total of all reporting groups
Overall Participants 58 19 77
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
Between 18 and 65 years
16
27.6%
4
21.1%
20
26%
>=65 years
42
72.4%
15
78.9%
57
74%
Age (years) [Median (Full Range) ]
Median (Full Range) [years]
68
69
68
Sex: Female, Male (Count of Participants)
Female
0
0%
0
0%
0
0%
Male
58
100%
19
100%
77
100%
Region of Enrollment (participants) [Number]
United States
58
100%
19
100%
77
100%

Outcome Measures

1. Primary Outcome
Title Acute Grade 3 or Higher Treatment-related Toxicity Rate.
Description Number of participants that experienced acute grade 3 or higher, treatment-related toxicity based on CTCAE version 3.0 criteria.
Time Frame 6 months after the completion of radiation therapy

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title HR-A HR-B
Arm/Group Description < 15% risk of + LN < 15% risk of + LN: Total of 54 CGE over 30 treatments to prostate + SV, then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months. > 15% risk of + LN > 15% risk of + LN: Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months.
Measure Participants 58 19
Number [participants]
1
1.7%
3
15.8%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HR-A, HR-B
Comments
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.0001
Comments
Method Chi-squared
Comments One-sided binomial test of univariate probability distributions
2. Secondary Outcome
Title Collect and Analyze Quality of Life, Treatment-related Late Morbidity, Disease Control, and Survival Outcome Parameters.
Description
Time Frame After radiation: every 6 months for 3 years, then annually for 20 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
3. Secondary Outcome
Title Collect and Analyze Treatment, Biologic and Diagnostic Information That May Impact Quality of Life, Disease Control, Morbidity and/or Survival Outcomes.
Description
Time Frame After radiation: every 6 months for 3 years, then annually for 20 years

Outcome Measure Data

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

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group Title HR-A HR-B
Arm/Group Description < 15% risk of + LN < 15% risk of + LN: Total of 54 CGE over 30 treatments to prostate + SV, then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months. > 15% risk of + LN > 15% risk of + LN: Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months.
All Cause Mortality
HR-A HR-B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN)
Serious Adverse Events
HR-A HR-B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 1/58 (1.7%) 3/19 (15.8%)
Gastrointestinal disorders
Diarrhea - acute 0/58 (0%) 0 3/19 (15.8%) 3
Constipation - acute 1/58 (1.7%) 1 0/19 (0%) 0
Abdominal cramping - acute 0/58 (0%) 0 1/19 (5.3%) 1
General disorders
Pain - acute 0/58 (0%) 0 1/19 (5.3%) 1
Other (Not Including Serious) Adverse Events
HR-A HR-B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 13/58 (22.4%) 11/19 (57.9%)
Gastrointestinal disorders
Constipation - acute 5/58 (8.6%) 5 2/19 (10.5%) 2
Diarrhea - acute 4/58 (6.9%) 4 7/19 (36.8%) 7
Abdominal cramping acute 1/58 (1.7%) 1 2/19 (10.5%) 2
Proctitis - acute 1/58 (1.7%) 1 1/19 (5.3%) 1
Rectal bleeding - late 2/58 (3.4%) 2 1/19 (5.3%) 1
Abdominal cramping - late 1/58 (1.7%) 1 0/19 (0%) 0
Constipation - late 1/58 (1.7%) 1 0/19 (0%) 0
General disorders
Pain - acute 6/58 (10.3%) 6 2/19 (10.5%) 2
Renal and urinary disorders
Dysuria - acute 3/58 (5.2%) 3 0/19 (0%) 0
Obstruction - acute 1/58 (1.7%) 1 0/19 (0%) 0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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 Nancy P. Mendenhall, MD
Organization University of Florida Health Proton Therapy Institute
Phone 904-588-1000
Email rtoton@floridaproton.org
Responsible Party:
University of Florida
ClinicalTrials.gov Identifier:
NCT01040624
Other Study ID Numbers:
  • UFPTI 0703 - PR05
  • IRB201702459
First Posted:
Dec 29, 2009
Last Update Posted:
Dec 3, 2021
Last Verified:
Dec 1, 2021