Phase III Clinical Trial on Conventionally Fractionated Conformal Radiotherapy (CF-CRT) Versus CF-CRT Combined With High-dose-rate Brachytherapy or Stereotactic Body Radiotherapy for Intermediate and High-risk Prostate Cancer.
18 Years
80 Years
Male
Prostate Cancer
Trial Information
Phase III Clinical Trial on Conventionally Fractionated Conformal Radiotherapy (CF-CRT) Versus CF-CRT Combined With High-dose-rate Brachytherapy or Stereotactic Body Radiotherapy for Intermediate and High-risk Prostate Cancer.
Prostate cancer is considered as a disease with relatively slow natural course and good
clinical prognosis. Such description, however, does not well refer to intermediate and
high-risk cases where long-term rate of biochemical progression remains not satisfactory,
and the available treatment modalities entail a considerable morbidity. Over the last decade
several competitive therapeutic approaches have evolved in curative treatment for
intermediate and high-risk prostate cancer. The use of intensity-modulated radiation therapy
(IMRT) made possible to escalate the total dose to the prostate without excessive toxicity.
Based on assumption of low value of low α/β value for adenocarcinoma of prostate, there is a
potential of escalating the biological dose to the tumor with higher dose per fraction.
High-dose-rate brachytherapy (HDR-BT) is one of the options, with the ability to conform
radiation dose to the prostate with sharp dose gradient adjacent to critical organs. An
increasing number of studies suggest its usefulness as a boost in intermediate and high risk
disease. The randomized trial conducted in UK compared external beam radiotherapy (EBRT)
alone with EBRT and HDR brachytherapy as a boost. Combining EBRT with HDR BT - boost
resulted in significantly higher relapse-free-survival (RFS) with comparable incidence of
severe late toxicity. However, the total dose used in EBRT alone - arm and radiotherapy
technique may be considered suboptimal according to current standards.
Stereotactic body radiotherapy (SBRT) may be an interesting alternative to HDR
brachytherapy, not requiring implantation of multiple catheters and anesthesia. SBRT boost
for advanced localized prostate cancer has the potential to reduce toxicity while escalating
the dose. First results of trials combining conventional irradiation with hypofractionated
stereotactic boost and institutional pilot results gave promising outcome.
The comparison of these modalities of radiation therapy for prostate cancer will be
performed in the current phase III trial study.
Inclusion Criteria:
1. Pathologically proven adenocarcinoma of the prostate
2. Clinical stage T1-T3a (Intermediate or high risk features according to NCCN criteria)
3. No evidence of nodal or distant spread as determined by chest X-ray, bone scan and
abdominal ultrasound or CT-scan or other investigations such as Positron Emission
Tomography [PET] scan if required
4. No evidence of bulky spread beyond the capsule of the prostate, no seminal vesicle
involvement assessed by TRUS or MRI of pelvis.
5. Good performance status (ZUBROD <2, Karnofsky index >=80%).
6. No contradictions for spinal anesthesia.
7. No contradictions for hormonal treatment (androgen deprivation).
8. Adequate bone marrow, renal and liver function.
9. Life expectancy in excess of 5 years.
10. No prior malignancy, except basal or squamous cell skin cancer.
11. Informed consent for participation in the study (confirmed by the signature together
with the standard medical consent form for radiotherapy within the pelvis)
Exclusion Criteria:
1. Different histology than adenocarcinoma.
2. Previous or concurrent malignancy, with the exception of basal cell carcinoma of the
skin.
3. Locally advanced disease: bulky T3a and/or T3b.
4. Presence of metastatic disease (nodal and/or distant).
5. PSA >100ng/ml
6. Any previous therapy other than hormonal treatment.
7. Concurrent uncontrolled medical conditions.
8. Medical or psychiatric conditions that compromise the patient's ability to give
informed consent.
9. Withdrawal of informed consent.
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Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Freedom from biochemical failure (FFBF)
Outcome Description:
according to Phoenix definition (rise of PSA level of 2 ng/ml over the absolute nadir)
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
Rafał Suwiński, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland
Authority:
Poland: Ethics Committee
Study ID:
CRT/BT/SBRT-COI-02
NCT ID:
NCT01839994
Start Date:
June 2013
Completion Date:
December 2018
Related Keywords:
- Prostate Cancer
- prostate cancer,
- high-dose-rate brachytherapy boost,
- stereotactic body radiotherapy boost,
- conformal radiotherapy,
- randomized trial
- Prostatic Neoplasms
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