A Randomized, Open Label, Phase III, Multicenter, 2-Arm Study of Androgen deprivation +/- Taxotere? (Docetaxel) for Non metastatic Prostate Cancer Patients with a Rising PSA.

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Cancer [C04]; Patients with prostate cancer.The study will include two patient cohorts, which at inclusion has a similar risk for progression of the disease at 5 years, and risk of later prostate cancer death. The first patient group are patients with PSA relapse after curative treatment, and the 2nd one are patients with locally advanced disease.

• Registration Number: EUCTR2008-003138-33-DK
• Lead Sponsor: Scandinavian Prostate Cancer Group (SPCG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 430

Inclusion Criteria

*Men > 18 and =80 years of age.
*WHO/ECOG performance status 0 – 1.
*Histological proven adenocarcinoma of the prostate.
*Patients who are planned to receive antiandrogen (bicalutamide 150 mg x 1)treatment,
*After Curative treatment
- Prostatectomy: PSA >10 OR PSA DT < 12 months and PSA > 0.5 (PSA doubling time calculation must start at a minimum value of >0.5)
- Radiation: PSA > +2.0 above nadir and PSA >10 OR PSA DT < 12 months and PSA > 0.5. (PSA bouncing after radiotherapy should be excluded according to the local traditions, and PSA doubling time calculation must start at a minimum value of >0.5)
*In locally advanced (or local not suitable for curative therapy) prostate cancer patients, PSA < 100 is required before inclusion AND one of the following
- PSA DT < 12 months or
- PSA >20 or
- Gleason score 8-10,
*Previous hormonal therapy in conjunction with radiotherapy is allowed, provided that the total duration of therapy does not exceed 12 months and has to be stopped > 12 months ago.
*Testosterone >5nmol/l
*Adequate haematological-, liver- and kidney function.
*Negative bone scan not more than 3 months prior to start
*Additional CT or ultrasound of thorax, abdomen pelvis is optional.
*Written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 430

Exclusion Criteria

*Positive Bone scan
*Any distant metastasis detected by CT or ultrasound.
*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 5 years.
*Previous chemotherapy or randomised in SPCG 12/AdPro or SPCG 13/AdRad.
*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.
*Symptomatic peripheral neuropathy = CTCAE grade 2.
*Patients who by altered physical or psychological state not are able to co-operate or participate in the trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate and compare progression free survival (PFS) between the two treatment arms.;Secondary Objective: To evaluate and compare<br>•Metastasis free survival <br>•Cancer specific survival<br>•Overall survival<br>•Quality of Life (QoL) <br>•PSA doubling time after progression;Primary end point(s): To evaluate and compare progression free survival (PFS) between the two treatment arms. PFS is defined as PSA or Radiographic progression or death due to any course in the absence of previous documentation of disease progression, whichever occurs first.