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Randomized Adjuvant Phase III Trial of Six Cycles of Docetaxel+Hormonal Treatment Versus Hormonal Treatment in Patients With Intermediate or High-risk Prostate Cancer Treated With Radical Radiotherapy


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

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Trial Information

Randomized Adjuvant Phase III Trial of Six Cycles of Docetaxel+Hormonal Treatment Versus Hormonal Treatment in Patients With Intermediate or High-risk Prostate Cancer Treated With Radical Radiotherapy


Primary endpoint:

- PSA progression rate, ASTRO guidelines.

Secondary endpoints:

- PSA doubling time after progression

- Quality of Life (QoL)

- Safety

- Metastases free survival

- Overall survival


Inclusion Criteria:



- Men > 18 and ≤75 years of age.

- WHO/ECOG performance status 0 - 1.

- Histological proven adenocarcinoma of the prostate within 12 months prior to
randomisation

- One of the following:

- T2 with Gleason score 7(4+3 ) and PSA >10 ng/ml to < 70 ng/ml

- T2 with Gleason 8-10, any PSA < 70 ng/ml

- any T3 tumour

- Prior neoadjuvant hormone therapy is mandatory for all patients

- Adequate haematological-, liver- and kidney function. (Hemoglobin > 110 g/l,
neutrophils > 1.5 x 109/ l, platelets > 150 x 109/ l, ASAT and ALAT < 1.5 x ULN, ALP
< 1.5 x ULN, creatinine < 1.5 x ULN)

- Written informed consent

Exclusion Criteria:

- M+

- N+ clinical or pathological

- Patients with a history of previous malignant disease. Exceptions should be made for
basal cell carcinoma (BCC) and squamous cell carcinoma of the skin. Exceptions should
also be made for curatively treated malignant disease, which has been disease free
for the past five years.

- Previous radiotherapy to the pelvic region.

- Previous chemotherapy within 5 years.

- Systemic corticosteroids within 6 months prior to randomisation.

- Unstable cardiovascular disease, including myocardial infarction, within 6 months
prior to randomisation.

- Active untreated infectious disease, including tuberculosis, MRSA.

- Active gastric ulcer.

- Known hypersensitivity to Polysorbate 80 (an excipient of docetaxel)

- Other serious illness or medical condition

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:

PSA progression rate

Outcome Time Frame:

From randomization to progression

Safety Issue:

No

Principal Investigator

Pirkko-Liisa i Kellokumpu-Lehtinen, Prof

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tampere University Hospital

Authority:

Finland: Finnish Medicines Agency

Study ID:

SPCG-13

NCT ID:

NCT00653848

Start Date:

May 2007

Completion Date:

December 2017

Related Keywords:

  • Prostate Cancer
  • Adjuvant treatment, intermediate and high risk, radical radiotherapy
  • Prostatic Neoplasms

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