Androgen Suppression Combined With Elective Nodal and Dose Escalated Radiation Therapy

Inclusion Criteria:

1. Patients must have histologically-proven prostate cancer stage T1c -T3a (UICC 1997).
2. Patients with clinically organ-confined disease must meet the Canadian consensus definition of intermediate risk disease (i.e any one or more of: CS = T2b \[UICC1997 = bilateral palpable intra-capsular disease\], GS = 7, or iPSA \>10 and 20).
3. Patients with Gleason sum 8 and/or PSA \> 20 must have a CT pelvis, and nuclear medicine bone scan showing no evidence of nodal (N0) or distant metastases (M0).
4. Registration must occur within 36 weeks of biopsy.
5. Patients with clinical or pathological evidence of seminal vesicle invasion (stage T3b) or involvement of adjacent pelvic organs/structures (stage T4) are not eligible.
6. Pre-intervention PSA must not exceed 40 ng ml-1.
7. Patients must have a chest x-ray and the following blood tests within four weeks of registration: PSA, PAP, testosterone, CBC, electrolytes, BUN, creatinine, AST, LDH and alkaline phosphatase. Patients with values for one or more of these tests that fall outside the normal range will not necessarily be ineligible, however, their eligibility will need to be reviewed by the study coordinator.
8. Patients must have an ECG within four weeks of registration. Patients with ECGs judged to be significantly abnormal require a consultation with a cardiologist to ascertain their suitability for general or spinal anesthesia.
9. Patients judged clinically to have a prostate volume \> 65 cm3 prior to starting androgen suppression must have a transrectal ultrasound for volume estimation. Patients with TRUS prostate volumes \> 75 cm3 prior to starting androgen suppression are not eligible for the study.
10. Patients may have been started on neoadjuvant androgen suppression prior to registration provided:

    * there is documentation of pre-treatment PSA and
    * in the case of patients with iPSA \>20 and/or Gleason sum 8, a bone scan and CT pelvis were done prior to or within 4 weeks after starting neoadjuvant androgen suppression.
11. Patients must not have received prior surgical treatment for prostate cancer including transurethral resection of the prostate (TURP), transurethral resection of the bladder neck (TURB), cryotherapy, laser ablation, or microwave therapy.
12. Patients should have an estimated life expectancy of at least 5 years with an ECOG performance status of 0-2.
13. Patients may not have received prior radiation therapy to the pelvis.
14. Patients must be fit for general or spinal anesthetic.
15. Patients on Coumadin therapy must be able to stop the therapy safely for at least 12 days. Documentation as to the safety of such an interruption in anticoagulation therapy must be provided by an appropriate specialist physician (usually a cardiologist or hematologist).
16. Patients must be judged to have no contraindication to high dose pelvic irradiation or LHRH agonist therapy.
17. Cancer survivors are eligible providing that all three of the following criteria are met:

    * The patient has undergone potentially curative therapy for all prior malignancies.
    * There has been no evidence of recurrence for at least five years following potentially curative therapy. (For non-melanoma skin cancer the five-year requirement does not apply.)
    * The patient is considered by the treating physician to be at low risk of recurrence from prior malignancies.