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Conventional or Hypofractionated High Dose Intensity Modulated Radiotherapy for Prostate Cancer: CHHIP

Phase 3
Open (Enrolling)
Prostate Cancer

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Trial Information

Conventional or Hypofractionated High Dose Intensity Modulated Radiotherapy for Prostate Cancer: CHHIP


- 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

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

- Arm III: Patients undergo hypofractionated high-dose IMRT in 19 fractions over 3.8

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


- Histologically confirmed adenocarcinoma of the prostate, meeting the following

- 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)


- 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

- 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)


- 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:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Acute and late radiation-induced side effects

Safety Issue:


Principal Investigator

David P. Dearnaley, MD, FRCP, FRCR

Investigator Role:

Study Chair

Investigator Affiliation:

Royal Marsden NHS Foundation Trust



Study ID:




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