SPCG-13

A Randomized phase III trial of six cycles of docetaxel versus surveillance plus hormonal treatment after radical radiotherapy in patients with intermediate or high-risk prostate cancer (SPCG-13 AdRad)

As docetaxel is proven to be effective in late stages of prostate cancer with a large tumour burden it should be effective in primarily treated intermediate and high risk prostate cancer as an adjuvant treatment after radiotherapy to prevent early relapse. This will therefore be tested in a randomised phase III trial where patients will be randomized either to docetaxel or surveillance.

Finished

SPCG-13 info

Read more on ClinicalTrials.gov

clinicaltrials.gov

Principal investigator

Pirkko-Liisa Kellokumpu-Lehtinen, Finland

Contact details

Patients

T2, Gleason 7(4 3), PSA>10 ng/ml or T2, Gleason 8-10, any PSA or T3 prostate cancer diagnosed within 9 months in men>18 and ≤75 years

Treatment

neoadjuvant LHRH analog 3 months before, 3 months during and 3 months after radiotherapy of at least 74 Gy or brachytherapy plus/minus 6 cycles of docetaxel 75 mg/m² (control arm no docetaxel until PSA progression)

Primary study objective

PSA progression rate (ASTRO guidelines)

Secondary endpoints

PSA doubling time after progression, quality of life, safety, metastases free survival, overall survival

Inclusion period

2007 – 2012. Follow-up until end 2016. Report 2017

Number of patients

378, duration 5 years, start 2007

Data management

Tampere University Hospital

Monitoring

National basis

1 publications

Publications of the SPCG-13 trial

Toxicity in patients receiving adjuvant docetaxel + hormonal treatment after radical radiotherapy for intermediate or high-risk prostate cancer: a preplanned safety report of the SPCG-13 trial

Kellokumpu-Lehtinen PL, Hjälm-Eriksson M, Thellenberg-Karlsson C, Åström L, Franzen L, Marttila T, Seke M, Taalikka M, Ginman C

Prostate Cancer Prostatic Dis. 2012

Abstract