Prostate CancerPhase 3AdRadNCT00653848
Adjuvant Treatment of Prostate Cancer With Docetaxel or Not After Radical Radiotherapy
A Phase 3 study testing docetaxel in people with Prostate Cancer, run by Scandinavian Prostate Cancer Group at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 378 participants
- Where
- 1 siteNorway
- Study dates
- May 2007to 30 Aug 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
Read the detailed description
Primary endpoint:
- PSA progression rate, ASTRO guidelines.
Secondary endpoints:
- PSA doubling time after progression
- Quality of Life (QoL)
- Safety
- Metastases free survival
- Overall survival
- Conditions
- Prostate Cancer
- Being tested
- docetaxel
- Keywords
- Adjuvant treatment, high risk, radical radiotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxelDrug
Also called LHRH ananlog 9 months
docetaxel 75 mg/square meter i.v. every third week, six cycles
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel arm | Experimental | six of docetaxel every third week + hormonal treatment Receives: Drug: docetaxel |
| Control | No intervention | hormonal treatment only |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA progression rate
According to RTOG-ASTRO guidelines
Measured: From randomization to progression
Secondary outcomes (1)
PSA doubling time after progression, quality of life, safety, metastases free survival, overall survival
PSA doubling measured, FACT-P, detection of metastatic lesions
Measured: From randomisation to year 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2008 (estimated)
- Study startMay 2007
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 378 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scandinavian Prostate Cancer Group
- Sponsor type
- Research network
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Pirkko-Liisa i Kellokumpu-Lehtinen, Prof, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00653848
- Sponsor's protocol ID
- SPCG-13
- Other IDs
- 2006-001657-94
- Acronym
- AdRad
- Status last verified
- Mar 2021
- First submitted
- 2 Apr 2008
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00653848
- Acronym / sponsor ID
- AdRad / SPCG-13
- Conditions
- Prostate Cancer
- Keywords
- Adjuvant treatment, high risk, radical radiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 378 participants (actual)
- Lead sponsor
- Scandinavian Prostate Cancer GroupResearch network
- Collaborators
- Sanofi
- Study start
- May 2007
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 7 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Primary endpoint:
- PSA progression rate, ASTRO guidelines.
Secondary endpoints:
- PSA doubling time after progression
- Quality of Life (QoL)
- Safety
- Metastases free survival
- Overall survival
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docetaxel arm | Experimental | Drug: docetaxelsix of docetaxel every third week + hormonal treatment |
| Control | No intervention | –hormonal treatment only |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- Prior neoadjuvant hormone therapy is mandatory for all patients
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| docetaxelAlso: LHRH ananlog 9 monthsdocetaxel 75 mg/square meter i.v. every third week, six cycles | Drug | Docetaxel arm |
Primary outcome
PSA progression rate
Time frame: From randomization to progression
According to RTOG-ASTRO guidelines
1 secondary outcome
PSA doubling time after progression, quality of life, safety, metastases free survival, overall survival
Time frame: From randomisation to year 2014
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pirkko-Liisa i Kellokumpu-Lehtinen, Prof principal investigator
Tampere University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing docetaxel in people with Prostate Cancer, run by Scandinavian Prostate Cancer Group at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSA progression rate (time frame: From randomization to progression). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2021.