A Phase III Intensity Radiotherapy Dose Escalation for Prostate Cancer Using Hypofractionation
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Conventional Fractionated Intensity Modulated Radiotherapy; Hypofractionated Intensity Modulated Radiotherapy
Intervention 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.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 225.0
Sex: Male
Healthy volunteers: No
Keywords: Prostate Cancer; Radiation; Radiotherapy; Intensity Modulated Radiotherapy; IMRT; Hypofractionated Intensity Modulated Radiotherapy; HIMRT

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Biopsy proof of adenocarcinoma of the prostate.

          2. 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.

          3. CT-scan of pelvis (If Stage T3 disease) within 3 months of starting androgen ablation
             or signing protocol consent if no androgen ablation.

          4. Suitable medical condition; Zubrod <2.

          5. 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.

          6. Clinical (palpable) Stage T1b - T3b disease (1992 AJCC staging system).

          7. 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

          8. Gleason score <10.

          9. If Gleason score 8 or 9, then must have stage T1/T2 disease and pretreatment PSA less
             than or equal to 10 ng/ml.

         10. 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.

         11. Informed consent must be given.

         12. Patients randomized to Arm 1 may also participate in protocol 2004-0428.

        Exclusion Criteria:

          1. Prior pelvic radiotherapy.

          2. Greater than 4 months of prior hormone ablation therapy.

          3. Prior or planned radical prostate surgery.

          4. Clinical, radiographic or pathologic evidence of nodal or distant metastatic disease.

          5. 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.

          6. Zubrod status greater than or equal to 2.

          7. Pretreatment PSA >20 ng/ml.

          8. Gleason score of 10.

          9. Palpable stage T3c (seminal vesicle involvement) or T4 disease.