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

Status unconfirmed · Phase 3

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00667888

Run by

M.D. Anderson Cancer Center

People needed

225

Starts

2001-01-03

Expected to finish

2021-10-01

Last updated by the study team

2021-01-25

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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