Conventional or Hypofractionated High Dose Intensity Modulated Radiotherapy for Prostate Cancer: CHHIP
N/A
N/A
Male
Prostate Cancer
Trial Information
Conventional or Hypofractionated High Dose Intensity Modulated Radiotherapy for Prostate Cancer: CHHIP
OBJECTIVES:
- Determine the safety and efficacy of conventional vs hypofractionated high-dose
intensity-modulated radiotherapy in patients with localized prostate cancer.
- Determine the side effects of these regimens in these patients.
- Determine whether hypofractionated radiotherapy schedules will improve the therapeutic
ratio by either improving tumor control or reducing normal tissue side effects.
- Compare acute and late treatment-related gastrointestinal and urological toxicity in
these patients.
- Determine different prostate-specific antigen-related endpoints for local failure and
distant metastases.
- Extend the database of patients treated to escalated doses with dose-volume histograms
(DVHs) of normal tissues at risk and relate these to common toxicity endpoints.
- Develop a model to estimate normal tissue complication probability (NTCP) of rectum and
bladder for hypofractionated as well as conventional dose-escalated radiotherapy
schedules.
OUTLINE: This is a multicenter, randomized, pilot study. Patients are stratified according
to risk of seminal vesicle involvement (low-risk vs moderate-risk or high-risk).
- Hormone therapy: Patients receive androgen-deprivation therapy comprising an injection
of luteinizing hormone-releasing hormone (LHRH) agonist once monthly for 3-6 months and
oral cyproterone acetate beginning the week before the first LHRH agonist injection and
continuing for at least 2 weeks after each LHRH agonist injection. Within one week
after the last LHRH agonist injection, patients proceed to radiotherapy.
- Radiotherapy: Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients undergo conventional high-dose intensity-modulated radiotherapy
(IMRT) in 37 fractions over 7.5 weeks.
- Arm II: Patients undergo hypofractionated high-dose IMRT in 20 fractions over 4
weeks.
- Arm III: Patients undergo hypofractionated high-dose IMRT in 19 fractions over 3.8
weeks.
In all arms, treatment continues in the absence of unacceptable toxicity.
Quality of life is assessed periodically during study treatment.
After completion of study treatment, patients are followed periodically for up to 15 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 2,163 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate, meeting the following
criteria:
- Clinical stage T1b-T3a, N0, M0
- Locally confined disease
- Previously untreated disease
- Prostate-specific antigen (PSA) ≤ 30 ng/mL
- Estimated risk of seminal vesicle involvement < 30%
- Estimated risk of seminal vesicle involvement is defined as PSA + ([Gleason
score - 6] x 10) (i.e., if Gleason score ≤ 6, then PSA must be ≤ 30 ng/mL; if
Gleason score = 7, then PSA must be < 20 ng/mL; if Gleason score = 8, then PSA
must be < 10 ng/mL; if Gleason score = 9 or 10 patient is ineligible)
PATIENT CHARACTERISTICS:
- WHO performance status 0 or 1
- Life expectancy > 10 years (5 years for patients with poorly differentiated cancers)
- WBC > 4,000/mm^3
- Hemoglobin > 11g/dL
- Platelet count > 100,000/mm^3
- No other active malignancy within the past 5 years except basal cell carcinoma
- No hip prosthesis or fixation that would interfere with standard radiation beam
configuration
- No comorbid conditions likely to impact on the advisability of radical radiotherapy
(e.g., previous inflammatory bowel disease, previous colorectal surgery, significant
bladder instability, or urinary incontinence)
PRIOR CONCURRENT THERAPY:
- No prior pelvic radiotherapy
- No prior radical prostatectomy
- No prior androgen-deprivation therapy
- No concurrent full anticoagulation therapy with warfarin or heparin
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Acute and late radiation-induced side effects
Safety Issue:
Yes
Principal Investigator
David P. Dearnaley, MD, FRCP, FRCR
Investigator Role:
Study Chair
Investigator Affiliation:
Royal Marsden NHS Foundation Trust
Authority:
Unspecified
Study ID:
CDR0000510112
NCT ID:
NCT00392535
Start Date:
October 2002
Completion Date:
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- stage IIB prostate cancer
- stage IIA prostate cancer
- stage III prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|
