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Phase II Trial of SBRT + or - IMRT in Treatment of Patients With Clinically Confined Prostate Adenocarcinoma

Primary Purpose

Prostate Adenocarcinoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SBRT
Sponsored by
GenesisCare USA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Adenocarcinoma focused on measuring Locally confined

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Histologically determined adenocarcinoma is required.
  • All other histologies are excluded.
  • Tissue for diagnosis must be obtained by transrectal ultrasound biopsy.
  • Gleason scoring classification of the biopsy specimen is required and must be greater than or equal to 7.
  • 2002 AJCC clinical cancer stage as determined by either urologist or radiation oncologist must be T1c - T2b, N0, M0.
  • N0 stage may be assigned following either negative imaging or negative pathologic assessment.
  • Prostate volume as assessed by TRUS must be less than 60 cc. 3.1.5.
  • PSA must be less than 20 ng/ml. ,
  • Age ≥ 18,
  • IPSS voiding symptoms score must be less than 18,
  • Study consent form must be signed by the patient.

Exclusion Criteria:

  • Gleason score of 8 - 10,
  • Clinical stage T3 - T4,
  • Age ≤ 18,
  • Any evidence of nodal (N1) or distant (M1) disease,
  • Prostate volume as assessed by TRUS > 60 cc,
  • PSA > 20 ng/ml,
  • IPSS voiding symptoms score > 18,
  • Prior TURP,
  • Prior pelvic radiotherapy or chemotherapy,
  • Prior prostatectomy,
  • Prior cancer other than basal cell or squamous cell skin carcinoma unless free of disease for > 5 years,
  • Current medical or psychiatric illness that may interfere with treatment completion and followup,
  • Hip prosthesis,
  • Unable or unwilling to give informed consent

Sites / Locations

  • 21st Century Oncology
  • 21st Century Oncology
  • 21st Century Oncology
  • Century Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

SBRT only

IMRT plus SBRT Boost

Arm Description

Patients assigned to this arm receive 8.0 Gy per fraction for 5 fractions for a total of 40 Gy

Patients assigned to this arm receive 1.8 Gy per fraction for 25 fractions over 5 weeks for a total of 45.0 Gy followed by an SBRT boost of 5.5 Gy per fraction for 4 fractions after IMRT for a total of 22.0 Gy

Outcomes

Primary Outcome Measures

To estimate the rate of chronic grade 3 - 5 genitourinary (GU) and gastrointestinal (GI) toxicity of SBRT either as a boost following conventionally fractionated IMRT or as a monoradiotherapy
At baseline, during treatment, and at 1 month, 3 months, 6 months, 9 months, and 12 months post treatment. For the second and third years after therapy completion, follow-up visits will be every 6 months. After the third year after therapy completion, follow-up visits will be annually for life, up to 10 years.

Secondary Outcome Measures

Full Information

First Posted
January 13, 2015
Last Updated
January 9, 2020
Sponsor
GenesisCare USA
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1. Study Identification

Unique Protocol Identification Number
NCT02339948
Brief Title
Phase II Trial of SBRT + or - IMRT in Treatment of Patients With Clinically Confined Prostate Adenocarcinoma
Official Title
A Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) With or Without Intensity Modulated Radiation Therapy (IMRT) in the Treatment of Patients With Clinically Confined Prostate Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
October 2019 (Actual)
Study Completion Date
October 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GenesisCare USA

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients with locally confined prostate adenocarcinoma (clinical stage T1c - T2bN0M0, Gleason score 7, PSA 20 ng/ml) are assigned to one of two treatment arms. Low risk patients (T1c-T2a and PSA <10 ng/ml and Gleason Score 6 or less) will receive 5 fractions of 8.0 Gy for a total of 40 Gy. Intermediate risk patients (T2b or PSA >10 ng/ml orGleason Score 7) will receive 1.8 Gy of IMRT for 25 fractions over 5 weeks for a total of 45 Gy. They will then receive a boost consisting of 4, 5.5 Gy fractions after IMRT for a total of 22 Gy.
Detailed Description
Patients with locally confined prostate adenocarcinoma (clinical stage T1c - T2bN0M0, Gleason score 7, PSA 20 ng/ml) are assigned to one of two treatment arms. Low risk patients (T1c-T2a and PSA <10 ng/ml and Gleason Score 6 or less) will receive 5 fractions of 8.0 Gy for a total of 40 Gy. Intermediate risk patients (T2b or PSA >10 ng/ml orGleason Score 7) will receive 1.8 Gy of IMRT for 25 fractions over 5 weeks for a total of 45 Gy. They will then receive a boost consisting of 4, 5.5 Gy fractions after IMRT for a total of 22 Gy. All patients will be assessed for toxicity at periodic time points following completion of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Adenocarcinoma
Keywords
Locally confined

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
279 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SBRT only
Arm Type
Active Comparator
Arm Description
Patients assigned to this arm receive 8.0 Gy per fraction for 5 fractions for a total of 40 Gy
Arm Title
IMRT plus SBRT Boost
Arm Type
Active Comparator
Arm Description
Patients assigned to this arm receive 1.8 Gy per fraction for 25 fractions over 5 weeks for a total of 45.0 Gy followed by an SBRT boost of 5.5 Gy per fraction for 4 fractions after IMRT for a total of 22.0 Gy
Intervention Type
Radiation
Intervention Name(s)
SBRT
Other Intervention Name(s)
SBRT only
Intervention Description
8.0 Gy per fraction for 5 fractions for a total of 40 Gy
Primary Outcome Measure Information:
Title
To estimate the rate of chronic grade 3 - 5 genitourinary (GU) and gastrointestinal (GI) toxicity of SBRT either as a boost following conventionally fractionated IMRT or as a monoradiotherapy
Description
At baseline, during treatment, and at 1 month, 3 months, 6 months, 9 months, and 12 months post treatment. For the second and third years after therapy completion, follow-up visits will be every 6 months. After the third year after therapy completion, follow-up visits will be annually for life, up to 10 years.
Time Frame
Periodical (baseline, during treatment, and at 1 month, 3 months, 6 months, 9 months, and 12 months post treatment. For the second and third years after therapy completion, follow-up visits will be every 6 months. Then annually for ____ years.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Histologically determined adenocarcinoma is required. All other histologies are excluded. Tissue for diagnosis must be obtained by transrectal ultrasound biopsy. Gleason scoring classification of the biopsy specimen is required and must be greater than or equal to 7. 2002 AJCC clinical cancer stage as determined by either urologist or radiation oncologist must be T1c - T2b, N0, M0. N0 stage may be assigned following either negative imaging or negative pathologic assessment. Prostate volume as assessed by TRUS must be less than 60 cc. 3.1.5. PSA must be less than 20 ng/ml. , Age ≥ 18, IPSS voiding symptoms score must be less than 18, Study consent form must be signed by the patient. Exclusion Criteria: Gleason score of 8 - 10, Clinical stage T3 - T4, Age ≤ 18, Any evidence of nodal (N1) or distant (M1) disease, Prostate volume as assessed by TRUS > 60 cc, PSA > 20 ng/ml, IPSS voiding symptoms score > 18, Prior TURP, Prior pelvic radiotherapy or chemotherapy, Prior prostatectomy, Prior cancer other than basal cell or squamous cell skin carcinoma unless free of disease for > 5 years, Current medical or psychiatric illness that may interfere with treatment completion and followup, Hip prosthesis, Unable or unwilling to give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Constantine Mantz, MD
Organizational Affiliation
GenesisCare USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
21st Century Oncology
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
Facility Name
21st Century Oncology
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
21st Century Oncology
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Century Oncology
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29577
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Phase II Trial of SBRT + or - IMRT in Treatment of Patients With Clinically Confined Prostate Adenocarcinoma

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