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Intermediate-risk Prostate Cancer : Assessment of Hypofractionated Stereotactic Boost - Prospective Phase II Study


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Cancer

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Trial Information

Intermediate-risk Prostate Cancer : Assessment of Hypofractionated Stereotactic Boost - Prospective Phase II Study


Inclusion Criteria:



- Prostate adenocarcinoma proved by histology

- With at least one of this intermediate-risk criterias:

- T2b

- and/or PSA between 10 et 20 ng/ml

- and/or Gleason score = 7

- Prostatic volume ≤ 80 cc

- No adenopathy(lymph node < 1.5 cm on scanner or MRI and/or in lymph node dissection)

- No metastasis (bone scan)

- Age >= 18 ans

- No prior pelvic irradiation

- No prior anticancer treatment (prostatectomy, chemotherapy, hormonotherapy > 3
months)

- Performance status (ECOG) < 1

- No contraindication of fiducials implantation, hemostasis disorders must be treated
before the implantation

- Life expectancy >= 10 weeks

- Patient affiliated to health insurance

- Informed consent signed by the patient

Exclusion Criteria:

- Cancer no histologically proved

- Unfavorable-risk(T2c and/or PSA > 20 ng/ml and/or Gleason > 7)

- Favorable-risk(T1c T2a and PSA < 10 ng/ml and Gleason < 7)

- T3 and T4

- History of cancer uncontrolled and/or treated since less of 5 years (except basal
cell carcinoma of the skin)

- Contraindication to MRI

- IPSS score > 10

- Recurrent or metastatic disease

- Allergy to gold

- Patient already included in another therapeutic trial with an experimental molecule

- Unable for medical follow-up (geographic, social or mental reasons)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change from baseline in rectal functions

Outcome Description:

Assessment of rectal toxicity according to the NCI-CTCAE v4.0 scale. Acute toxicities are defined as all toxicities occurring within 6 months after the start of radiotherapy, late toxicities are those that occur beyond this period.

Outcome Time Frame:

Every 3 months after boost irradiation during 1 year and then every 6 months during 2 years

Safety Issue:

Yes

Principal Investigator

Eric LARTIGAU, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Oscar Lambret

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

CKNO-PRO-0901

NCT ID:

NCT01596816

Start Date:

August 2010

Completion Date:

September 2016

Related Keywords:

  • Cancer
  • prostate cancer
  • Prostatic Neoplasms

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