A Prospective Single-Arm Phase I/II Study Using 11C-Choline PET Scans for Dose Escalated Hypofractionated Image Guided Inversely Planned Intensity Modulated External Beam Radiotherapy With Boost to PET Defined Dominant Intraprostatic Lesions and as a Predictive Factor for Biochemical Disease-Free Survival in Patients With Localized Prostate Cancer


Condition: Prostatic Neoplasms

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02004418

Sponsor: AHS Cancer Control Alberta

Phase: Phase 1/Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Biopsy proven prostate cancer with an intermediate risk feature defined as
  3. Gleason score 7, PSA <20, T1-T2C or
  4. Gleason score 6, PSA 10-20, T1-T2C or
  5. Gleason Score 6 or 7, PSA <20, T2C
  6. Localized disease based on staging investigations including bone scan, CT abdomen and pelvis, and any other clinically indicated staging investigations
  7. Eligible for curative intent external beam radiotherapy
  8. Able and willing to follow instructions and comply with protocol
  9. Provide written informed consent prior to participation in the study
  10. Karnofsky Performance Scale Score 70-100

Exclusion Criteria:

  1. Have had a 11C-Choline PET scan performed within 4 weeks after any biopsies of the prostate (due to concern that acute post biopsy intraprostatic changes may affect scan accuracy)
  2. BMI ≥ 30
  3. The presence of a hip prosthesis
  4. Bilirubin ≥ 20 µmol/L
  5. AST or ALT ≥ 5 times the upper limits of normal
  6. Serious medical conditions which may prevent a patient from tolerating therapy such as: congestive heart failure, unstable angina, unstable ventricular arrhythmia, uncontrolled psychiatric conditions, serious infections and/or uncontrolled diabetes.
  7. Metastatic disease
  8. Prostate cancer with only low risk features or any high risk feature with a PSA ≥20 or T3 disease
  9. A history of previous carcinoma except for basal cell carcinoma
  10. Age < 18 years
  11. Prior treatment with hormonal therapy
  12. AUA prostate symptom score > 20
  13. Crohn's disease or ulcerative colitis
  14. Patient is unable to comply adequately iwth bowel or bladder prep during CT simulation

View trial on ClinicalTrials.gov