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Phase III Study Comparing Irradiation at a Dose of 80 Gy to Irradiation at 70 Gy in Unfavorable Prostate Cancers Associated With Prolonged Hormonal Therapy


Phase 3
18 Years
80 Years
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Phase III Study Comparing Irradiation at a Dose of 80 Gy to Irradiation at 70 Gy in Unfavorable Prostate Cancers Associated With Prolonged Hormonal Therapy


OBJECTIVES:

Primary

- Assess the impact of increasing the radiation dose 10 Gy on biochemical or clinical
progression-free survival at 5 years in patients with unfavorable-risk prostate cancer
receiving prolonged hormone therapy.

Secondary

- Evaluate overall and specific survival.

- Assess acute and late toxicities of different modalities (conformal or
intensity-modulated radiotherapy).

- Evaluate toxicities of the different doses with respect to hormonal therapy.

- Assess the quality of life (QLQ-C30 and PR 25).

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo 80 Gy of conformal or intensity-modulated radiotherapy 5 times
a week for 7-8 weeks.

- Arm II: Patients undergo 70 Gy of conformal or intensity-modulated radiotherapy 5 times
a week for 7-8 weeks.

In both arms, patients receive goserelin subcutaneously once every 3 months for up to 3
years.

After completion of study treatment, patients are followed up periodically for 10 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the prostate

- Unfavorable disease, defined by at least 1 of the following criteria:

- Clinical stage T3 or T4

- Gleason score ≥ 8

- Serum PSA ≥ 20 ng/mL and ≤ 100 ng/mL

- pN0 disease allowed if lymphadenectomy performed before patient began hormone therapy

- No pelvic lymph nodes ≥ 15 mm by CT scan or MRI

- No axillary lymph node involvement (pN1)

- No bone metastasis

- Must be starting hormonal treatment on or up to 6 months before beginning
radiotherapy

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- Life expectancy > 5 years

- Must be enrolled in a social security program

- No other cancer, except basal cell skin cancer, that has been treated or relapsed
within the past 5 years

- No severe uncontrolled hypertension (systolic BP ≥ 160 mm Hg or diastolic BP ≥ 90 mm
Hg)

- No contraindication to luteinizing hormone-releasing hormone agonists

- No contraindication to pelvic irradiation (e.g., scleroderma, chronic inflammatory
gastrointestinal disease)

- No hip prosthesis

- Must not be deprived of liberty or under guardianship

- No geographical, social, or psychological reasons that would preclude follow up

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior pelvic irradiation

- At least 3-4 months since prior transurethral resection

- No other prior surgery for prostate cancer

- No concurrent participation in another clinical trial which would require approval
upon entry to this trial

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Biochemical or clinical progression-free survival at 5 years

Safety Issue:

No

Principal Investigator

Christophe Hennequin, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hopital Saint-Louis

Authority:

Unspecified

Study ID:

CDR0000649028

NCT ID:

NCT00967863

Start Date:

October 2008

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage III prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms

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