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A Phase III Intensity Radiotherapy Dose Escalation for Prostate Cancer Using Hypofractionation

Primary Purpose

Prostate Cancer

Status

Unknown status

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Conventional Fractionated Intensity Modulated Radiotherapy

Hypofractionated Intensity Modulated Radiotherapy

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Radiation, Radiotherapy, Intensity Modulated Radiotherapy, IMRT, Hypofractionated Intensity Modulated Radiotherapy, HIMRT

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Biopsy proof of adenocarcinoma of the prostate.
Bone scan (If PSA >10 ng/ml or T3 disease) within 3 months of starting androgen ablation or signing protocol consent if no androgen ablation.
CT-scan of pelvis (If Stage T3 disease) within 3 months of starting androgen ablation or signing protocol consent if no androgen ablation.
Suitable medical condition; Zubrod <2.
Pretreatment PSA </=20 ng/ml. If PSA <4, must have Gleason greater than or equal to 7 and/or Stage T2b-T2c. PSA within 30 days of signing protocol consent. If neoadjuvant androgen ablation has been given, then the preandrogen ablation PSA should be used for stratification.
Clinical (palpable) Stage T1b - T3b disease (1992 AJCC staging system).
While a transrectal ultrasound will be obtained before treatment, the staging will not be based on these findings. If palpable T3 disease is present, then must have Gleason score <8 and pretreatment PSA less than or equal to 10 ng/ml
Gleason score <10.
If Gleason score 8 or 9, then must have stage T1/T2 disease and pretreatment PSA less than or equal to 10 ng/ml.
The patient must be able to understand the protocol and adhere to follow-up at 6-month intervals for the first 2 years and at yearly intervals thereafter.
Informed consent must be given.
Patients randomized to Arm 1 may also participate in protocol 2004-0428.

Exclusion Criteria:

Prior pelvic radiotherapy.
Greater than 4 months of prior hormone ablation therapy.
Prior or planned radical prostate surgery.
Clinical, radiographic or pathologic evidence of nodal or distant metastatic disease.
Concurrent, active malignancy, other than nonmetastatic skin cancer or early stage -chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for greater than or equal to 5 yr then the patient is eligible.
Zubrod status greater than or equal to 2.
Pretreatment PSA >20 ng/ml.
Gleason score of 10.
Palpable stage T3c (seminal vesicle involvement) or T4 disease.

Sites / Locations

University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Intensity Modulated Radiotherapy (IMRT)

Hypofractionated Intensity Modulated Radiotherapy (HIMRT)

Arm Description

A total dose of 75.6 Gy will be delivered in 42 fractions to the planning target volume (PTV).

A total dose of 72 Gy will be delivered in 30 fractions to the PTV.

Outcomes

Primary Outcome Measures

Conventional Radiotherapy (CIMRT) Versus Hypofractionated Radiotherapy (HIMRT)

To determine the progression of the number of participants who failed treatment after receiving (CIMRT) versus (HIMRT). PSA measured on (CIMRT) and (HIMRT) for each participant on both arms. Failure was defined as Prostate-specific antigen (PSA) failure using the Phoenix definition of nadir plus 2 ng/ml, or initiation of salvage therapy.

Secondary Outcome Measures

Full Information

NCT ID

NCT00667888

First Posted

April 24, 2008

Last Updated

January 4, 2021

Sponsor

M.D. Anderson Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT00667888

Brief Title

A Phase III Intensity Radiotherapy Dose Escalation for Prostate Cancer Using Hypofractionation

Official Title

A Phase III Intensity Radiotherapy Dose Escalation for Prostate Cancer Using Hypofractionation

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Unknown status

Study Start Date

January 3, 2001 (Actual)

Primary Completion Date

October 12, 2015 (Actual)

Study Completion Date

October 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The goal of this clinical research study is to compare using external beam radiotherapy with intensity modulated beams for fewer days at a higher dose per day to the same type of therapy for more days at a lower dose per day in the treatment of prostate cancer. The safety of these treatments will also be studied and compared.

Detailed Description

Patients in this study will be randomly picked (as in the toss of a coin) to be in one of two treatment groups. There is an equal chance of being in either group. Patients in Group 1 will be treated with intensity modulated radiotherapy (IMRT). These patients will receive 42 treatments, 5 days per week, over 8.5 weeks. This method has become the standard treatment at M.D. Anderson Cancer Center. Patients in Group 2 will also be treated with IMRT. However, these patients will only receive 30 treatments, 5 days per week, over 6 weeks. The dose per day for Group 2 patients is higher than for Group 1 and has the possibility of killing more tumor cells. Each external beam treatment requires about 10-20 minutes. However, patients can expect to spend 20 - 30 minutes on the treatment table because imaging measurements of prostate position will be done before each treatment. The total time in the radiation department each treatment day will be about an hour. After the radiotherapy is completed, patients will have a PSA blood test every 3 months for 2 years, then every 6 months for Years 3 - 5, then annually. They will be examined every 6 months during the first 2 years beginning 3 months after the completion of treatment, then annually. A needle biopsy of the prostate will be performed if these tests suggest recurrence. This is an investigational study. 225 patients will take part in this study. This study will take place at M. D. Anderson and possibly some affiliated hospitals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

Prostate Cancer, Radiation, Radiotherapy, Intensity Modulated Radiotherapy, IMRT, Hypofractionated Intensity Modulated Radiotherapy, HIMRT

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

225 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intensity Modulated Radiotherapy (IMRT)

Arm Type

Active Comparator

Arm Description

A total dose of 75.6 Gy will be delivered in 42 fractions to the planning target volume (PTV).

Arm Title

Hypofractionated Intensity Modulated Radiotherapy (HIMRT)

Arm Type

Experimental

Arm Description

A total dose of 72 Gy will be delivered in 30 fractions to the PTV.

Intervention Type

Radiation

Intervention Name(s)

Conventional Fractionated Intensity Modulated Radiotherapy

Other Intervention Name(s)

IMRT

Intervention Description

A total dose of 75.6 Gy will be delivered in 42 fractions to the planning target volume (PTV).

Intervention Type

Radiation

Intervention Name(s)

Hypofractionated Intensity Modulated Radiotherapy

Other Intervention Name(s)

HIMRT

Intervention Description

A total dose of 72 Gy will be delivered in 30 fractions to the PTV.

Primary Outcome Measure Information:

Title

Conventional Radiotherapy (CIMRT) Versus Hypofractionated Radiotherapy (HIMRT)

Description

Time Frame

8.5 years

10. Eligibility

Sex

Male

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Biopsy proof of adenocarcinoma of the prostate. Bone scan (If PSA >10 ng/ml or T3 disease) within 3 months of starting androgen ablation or signing protocol consent if no androgen ablation. CT-scan of pelvis (If Stage T3 disease) within 3 months of starting androgen ablation or signing protocol consent if no androgen ablation. Suitable medical condition; Zubrod <2. Pretreatment PSA </=20 ng/ml. If PSA <4, must have Gleason greater than or equal to 7 and/or Stage T2b-T2c. PSA within 30 days of signing protocol consent. If neoadjuvant androgen ablation has been given, then the preandrogen ablation PSA should be used for stratification. Clinical (palpable) Stage T1b - T3b disease (1992 AJCC staging system). While a transrectal ultrasound will be obtained before treatment, the staging will not be based on these findings. If palpable T3 disease is present, then must have Gleason score <8 and pretreatment PSA less than or equal to 10 ng/ml Gleason score <10. If Gleason score 8 or 9, then must have stage T1/T2 disease and pretreatment PSA less than or equal to 10 ng/ml. The patient must be able to understand the protocol and adhere to follow-up at 6-month intervals for the first 2 years and at yearly intervals thereafter. Informed consent must be given. Patients randomized to Arm 1 may also participate in protocol 2004-0428. Exclusion Criteria: Prior pelvic radiotherapy. Greater than 4 months of prior hormone ablation therapy. Prior or planned radical prostate surgery. Clinical, radiographic or pathologic evidence of nodal or distant metastatic disease. Concurrent, active malignancy, other than nonmetastatic skin cancer or early stage -chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for greater than or equal to 5 yr then the patient is eligible. Zubrod status greater than or equal to 2. Pretreatment PSA >20 ng/ml. Gleason score of 10. Palpable stage T3c (seminal vesicle involvement) or T4 disease.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Deborah A. Kuban, MD

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Texas MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mdanderson.org

Description

MD Anderson Cancer Center

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A Phase III Intensity Radiotherapy Dose Escalation for Prostate Cancer Using Hypofractionation

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