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Post-operative External Radiotherapy Combined With Concomitant and Adjuvant Hormonal Treatment Versus Postoperative External Radiotherapy Alone in Pathological Stage pT3a-b R0-1 N0M0 / pT2R1 N0M0, Gleason Score 5-10 Prostatic Carcinoma. A Phase III Study


Phase 3
N/A
80 Years
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Post-operative External Radiotherapy Combined With Concomitant and Adjuvant Hormonal Treatment Versus Postoperative External Radiotherapy Alone in Pathological Stage pT3a-b R0-1 N0M0 / pT2R1 N0M0, Gleason Score 5-10 Prostatic Carcinoma. A Phase III Study


OBJECTIVES:

- To investigate the potential benefit of post-operative radiotherapy with vs without a
combined and adjuvant treatment consisting of short-term androgen suppression for
improving the biochemical progression-free survival of patients who have undergone
radical prostatectomy for stage I-III prostate cancer.

OUTLINE: This is a multicenter study. Patients are stratified according to institution,
pathological stage (pT2R1 vs pT3R0 vs pT3R1), Gleason sum (≤ 3+4 vs ≥ 4+3), and WHO
performance status (0 vs 1). Within 3 months after radical surgery, patients are randomized
to 1 of 2 treatment arms.

- Arm I: Patients undergo post-operative conformal external beam irradiation for 6.5
weeks.

- Arm II: Beginning between days -5 to -3, patients receive an antiandrogen for 2-4
weeks. Beginning on day 0, patients receive leuprolide acetate subcutaneously once
(6-month depot) and undergo conformal external beam irradiation 5 times weekly for 6.5
weeks.

Patients undergo quality of life assessments periodically.

After completion of study treatment, patients are followed up every 6 months for 5 years and
then yearly thereafter.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of prostate cancer

- Clinical stage cT1-2-3a, N0, M0 disease pre-operatively

- Pre-operative PSA ≤ 5 x upper limit of normal

- Presenting the following conditions after radical prostatectomy:

- Gleason sum 5-10

- Pathologic stage pT2R1 (positive surgical margins with at least a tumor
trans-section > 2 mm) or pT3a-b (irrespective of margin status)

- Negative lymph node (LN) status (pN0) by LN sampling or LN dissection

- Unknown pathological LN status is not allowed, except for disease
classified as cT ≤ cT1c with baseline PSA ≤ 10 ng/mL, Gleason score < 7,
and ≥ 12 positive core biopsies < 50%

- Undetectable post-operative PSA within 3 months of surgery

PATIENT CHARACTERISTICS:

- WHO performance status 0-1

- WBC ≥ 3 x 10^9/L

- Hemoglobin ≥ 110 g/L

- Platelet count ≥ 100 x 10^9/L

- No other malignancy except adequately treated basal cell carcinoma of the skin or
other malignancy from which the patient has been disease free for at least 5 years

- No psychological, familial, sociological, or geographical condition potentially
hampering compliance with the study protocol and follow-up schedule

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- More than 5 years since prior chemotherapy

- No prior pelvic irradiation

- No prior bilateral orchiectomy

- No prior hormonal treatment except neoadjuvant treatment lasting ≤ 3 months

- No other concurrent anticancer agent or modality

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Biochemical progression-free survival

Safety Issue:

No

Principal Investigator

Michel Bolla, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHU de Grenoble - Hopital de la Tronche

Authority:

Unspecified

Study ID:

CDR0000644215

NCT ID:

NCT00949962

Start Date:

May 2009

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • Prostatic Neoplasms

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