Prostatic NeoplasmsPhase 3NCT03119857
Early Rising PSA Endocrine Treatment Versus Chemo-endocrine Therapy- SPCG14
A Phase 3 study testing Antiandrogen and Antiandrogen+docetaxel in people with Prostatic Neoplasms, run by Göteborg University at 5 sites in 4 countries.
Trial summary
Summary In patients with prostate cancer (PC) who have only biochemically relapsed disease after curative treatment (or some locally advanced PC patients), hormonal therapy remains a de facto standard of care treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- Antiandrogen and Antiandrogen+docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 349 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Feb 2009to Apr 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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men > 18 and ≤80 years of age.
- WHO/ECOG performance status 0 - 1 (WHO: World Health Organization; ECOG: Eastern Cooperative Oncology Group )
- 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)
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- 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 value > 5 nmol/l
- Adequate haematological-, liver- and kidney function. WBC(white blood cell ) 3.5 x 109/L ANC(absolute neutrophil count ) 1.5 x 109/L Platelet Count 150 x 109/L Haemoglobin > 120 g/L Total bilirubin ≤ ULN (upper limit of normal) unless due to Gilbert's disease Creatinine ≤ 1.5 x ULN or creatinine clearance of 60 cc/min or corresponding Iohexol clearance value ASAT(aspartate aminotransferase )/ALAT(alanine aminotransferase) ≤ 1.5 x ULN ALP (Alkaline phosphatase) < 1.5 x ULN
- Negative bone scan performed no more than 3 months prior to randomisation.
- Additional CT or ultrasound of thorax, abdomen and/or pelvis is optional.
- Written informed consent.
Who cannot join
- 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 (SPCG: Scandinavian Prostate Cancer Group).
- Systemic corticosteroids within 6 months prior to randomisation.
- Unstable cardiovascular disease, including myocardial infarction, within 6 months prior to randomisation.
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- Active untreated infectious disease, including tuberculosis, MRSA (Methicillin-resistant Staphylococcus aureus.
- 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.
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Finland2 sites
Kuopio University Hospital
Kuopio, Kuopio Kuopio, 70211
Turku University Hospital
Turku, 20521
About this study
Official title: A Randomized, Open Label, Multicenter, Phase III, 2-Arm Study of Androgen Deprivation +/- Taxotere (Docetaxel) for Non-metastatic Prostate Cancer Patients With a Rising PSA
Summary
In patients with prostate cancer (PC) who have only biochemically relapsed disease after curative treatment (or some locally advanced PC patients), hormonal therapy remains a de facto standard of care treatment. Adding docetaxel-based chemotherapy to a standard-of-care hormonal therapy has an increased potential to treat prostate cancer cell clones resistant to androgen withdrawal and to possibly shorten the duration of therapy needed to control the disease.
Read more
This clinical trial is designed on the basis of an unmet clinical need, as well as other factors including: 1) a consensus among investigators on endpoints for studies of patients with a rising PSA, 2) the ability to identify subjects at high risk for developing radiographic metastases, 3) the fact that hormonal therapy has already been shown to improve survival when applied early in the natural history, and 4) the availability of chemotherapy such as docetaxel that can improve survival in subjects with advanced disease.
It is our hypothesis that a more appropriate group of patients who may benefit from the curative potential of systemic chemo-hormonal modality is that with minimal, but detectable disease who have a high probability of developing metastatic disease, clinical symptoms and eventually death from prostate cancer in a defined time frame. The investigators hypothesize further that the approach is likely to be more effective at a time of minimal tumour burden, resulting in minimization of the overall burden of therapy and better quality of life while on treatment.
This trial will determine whether any benefit is gained by adding chemotherapy to hormonal therapy alone in the population of subjects with a rising PSA. Two therapeutic approaches will be compared in this two-arm randomized clinical trial. The control Arm A provides antiandrogen (bicalutamide 150 mg x 1) alone. The experimental Arm B involves treatment with docetaxel for 8-10 cycles and antiandrogen (bicalutamide 150 mg x 1) treatment. For the schematic representation of study design please see Section 7.3.1.
Subjects with a rising PSA following definitive local curative therapy will be eligible, if their PSA doubling time is < 12 months. Also PC patients planned for anti-.androgen therapy are eligible, with the same criteria. Subjects with radiographic metastases will be excluded. The primary endpoint of the trial is progression-free survival of subjects that do not experience biochemical failure at 60 months from the start of therapy.
Based on the yearly number of prostate cancer patients who undergo definitive local therapies and the estimated probabilities of relapse, upwards of 400 men (if +15% improvement) in the Scandinavian countries are potential candidates for this approach.
- Conditions
- Prostatic Neoplasms
- Being tested
- Antiandrogen, Antiandrogen+docetaxel
- Keywords
- Non-metastatic Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntiandrogenDrug
Antiandrogen+docetaxelDrug
Also called Taxotere
Antiandrogen (bicalutamide 150 mg x 1) + docetaxel (Taxotere®) 75mg/m2 (max 2.0m2) i.v. in 60 minutes on day 1. One cycle is 21 days. Docetaxel will be given for up to 8-10 cycles or until unacceptable toxicity or consent withdrawal whichever comes first.
Antiemetic therapy may be used if necessary.
| Study group | Role | What they receive |
|---|---|---|
| Antiandrogen | Active comparator | Antiandrogen (bicalutamide 150 mg x 1) p.o. alone, Receives: Drug: Antiandrogen |
| Antiandrogen + docetaxel | Experimental | Antiandrogen (bicalutamide 150 mg x 1) p.o. + Docetaxel 75 mg/m2 (maximum 2.0 m2 ) i.v. q 3 weeks x up to 8-10 cycles. Receives: Drug: Antiandrogen+docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Progression free survival defined as the time from randomization to the date of first documentation of:
- PSA progression PSA progression is considered to occur when PSA is +2.0 ng/ml above nadir. A confirmatory PSA must be taken no less than 6 weeks following the first rising PSA above nadir +2.0 ng/ml. If that confirmatory PSA also exceeds the above parameters, then progression has occurred. If the confirmatory PSA fails to confirm progression, then the patient will remain on study.
- Radiographic progression Outcome in patients who develop radiographically metastatic disease while on study will be defined as progression independent of their respective PSA values.
These patients will be followed for evaluation of survival.
- Death Death due to prostate cancer in the absence of previous documentation of disease progression,
Measured: From date of randomization until the date of first documented progression or date of death from any cause, which ever came first, assessed up to 60 months
Secondary outcomes (6)
Difference between groups in PSA doubling time (PSADT).
The PSADT can be calculated by the natural log of 2 (0.693) divided by the slope of the relation between the log of PSA and the time of PSA measurement.
Measured: From date of randomization until the date of first documented PSADT, assessed up to 60 months
Difference between groups regarding QoL
The quality of life (QoL) will be assessed using the FACT-P-T disease-specific subscale. The scoring will be in accordance with version 4 of the FACT manual.
Measured: At date of randomization and yearly, assessed up to 60 months
Difference between groups regarding metastasis free survival
Metastasis free survival will be assessed yearly by bone-scan after first PSA progression until the date of first documented metastasis on bone scan, date of death from any cause, whichever came first, assessed up to 100 months
Measured: From date of randomization until the date of first documented date of metastases, assessed yearly by bone-scan after first PSA_progression until first sign of metastasis, whichever came first, assessed up to 100 months
Difference between groups regarding overall survival
Survival will be assessed yearly up to 100 months after inclusion
Measured: From date of randomization until the date of death from any cause reported yearly by the study sites up to 100 months
Difference between groups regarding cancer specific survival
Cancer specific survival will be assessed yearly up to 100 months after inclusion
Measured: From date of randomization until date of death from prostate cancer,reported yearly by the study sites up to 100 months
Measurement of grade of toxicity of given treatments
Adverse events recording using NCI-CTCAE (v3.0)
Measured: At date of randomization, during treatment and follow up questionaries until 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study startFeb 2009
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- 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
- 349 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital
- Responsible party
- Principal investigator, Andreas Josefsson, Göteborg University
- Investigators
- Andreas Josefsson, PhD, Principal investigator, Univeristy of GothenburgIngela Turesson, Prof, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03119857
- Sponsor's protocol ID
- version 1.6
- Status last verified
- Aug 2021
- First submitted
- 14 May 2016
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Multicenter, Phase III, 2-Arm Study of Androgen Deprivation +/- Taxotere (Docetaxel) for Non-metastatic Prostate Cancer Patients With a Rising PSA
- ClinicalTrials.gov ID
- NCT03119857
- Acronym / sponsor ID
- version 1.6
- Conditions
- Prostatic Neoplasms
- Keywords
- Non-metastatic Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 349 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital
- Study start
- Feb 2009 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 19 Apr 2017 (actual)
- 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.
Summary
In patients with prostate cancer (PC) who have only biochemically relapsed disease after curative treatment (or some locally advanced PC patients), hormonal therapy remains a de facto standard of care treatment. Adding docetaxel-based chemotherapy to a standard-of-care hormonal therapy has an increased potential to treat prostate cancer cell clones resistant to androgen withdrawal and to possibly shorten the duration of therapy needed to control the disease.
This clinical trial is designed on the basis of an unmet clinical need, as well as other factors including: 1) a consensus among investigators on endpoints for studies of patients with a rising PSA, 2) the ability to identify subjects at high risk for developing radiographic metastases, 3) the fact that hormonal therapy has already been shown to improve survival when applied early in the natural history, and 4) the availability of chemotherapy such as docetaxel that can improve survival in subjects with advanced disease.
It is our hypothesis that a more appropriate group of patients who may benefit from the curative potential of systemic chemo-hormonal modality is that with minimal, but detectable disease who have a high probability of developing metastatic disease, clinical symptoms and eventually death from prostate cancer in a defined time frame. The investigators hypothesize further that the approach is likely to be more effective at a time of minimal tumour burden, resulting in minimization of the overall burden of therapy and better quality of life while on treatment.
This trial will determine whether any benefit is gained by adding chemotherapy to hormonal therapy alone in the population of subjects with a rising PSA. Two therapeutic approaches will be compared in this two-arm randomized clinical trial. The control Arm A provides antiandrogen (bicalutamide 150 mg x 1) alone. The experimental Arm B involves treatment with docetaxel for 8-10 cycles and antiandrogen (bicalutamide 150 mg x 1) treatment. For the schematic representation of study design please see Section 7.3.1.
Subjects with a rising PSA following definitive local curative therapy will be eligible, if their PSA doubling time is < 12 months. Also PC patients planned for anti-.androgen therapy are eligible, with the same criteria. Subjects with radiographic metastases will be excluded. The primary endpoint of the trial is progression-free survival of subjects that do not experience biochemical failure at 60 months from the start of therapy.
Based on the yearly number of prostate cancer patients who undergo definitive local therapies and the estimated probabilities of relapse, upwards of 400 men (if +15% improvement) in the Scandinavian countries are potential candidates for this approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antiandrogen | Active comparator | Drug: AntiandrogenAntiandrogen (bicalutamide 150 mg x 1) p.o. alone, |
| Antiandrogen + docetaxel | Experimental | Drug: Antiandrogen+docetaxelAntiandrogen (bicalutamide 150 mg x 1) p.o. + Docetaxel 75 mg/m2 (maximum 2.0 m2 ) i.v. q 3 weeks x up to 8-10 cycles. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Men > 18 and ≤80 years of age.
- WHO/ECOG performance status 0 - 1 (WHO: World Health Organization; ECOG: Eastern Cooperative Oncology Group )
- Histological proven adenocarcinoma of the prostate.
- Patients who are planned to receive antiandrogen (bicalutamide 150 mg x 1) treatment,
- After curative treatment
Key exclusion criteria (12 listed)
- 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 (SPCG: Scandinavian Prostate Cancer Group).
- Systemic corticosteroids within 6 months prior to randomisation.
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 |
|---|---|---|
| Antiandrogen | Drug | Antiandrogen |
| Antiandrogen+docetaxelAlso: TaxotereAntiandrogen (bicalutamide 150 mg x 1) + docetaxel (Taxotere®) 75mg/m2 (max 2.0m2) i.v. in 60 minutes on day 1. One cycle is 21 days. Docetaxel will be given for up to 8-10 cycles or until unacceptable toxicity or consent withdrawal whichever comes first. Antiemetic therapy may be used if necessary. | Drug | Antiandrogen + docetaxel |
Primary outcome
Progression free survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, which ever came first, assessed up to 60 months
Progression free survival defined as the time from randomization to the date of first documentation of: * PSA progression PSA progression is considered to occur when PSA is +2.0 ng/ml above nadir. A confirmatory PSA must be taken no less than 6 weeks following the first rising PSA above nadir +2.0 ng/ml. If that confirmatory PSA also exceeds the above parameters, then progression has occurred. If the confirmatory PSA fails to confirm progression, then the patient will remain on study. * Radiographic progression Outcome in patients who develop radiographically metastatic disease while on study will be defined as progression independent of their respective PSA values. These patients will be followed for evaluation of survival. - Death Death due to prostate cancer in the absence of previous documentation of disease progression,
6 secondary outcomes
Difference between groups in PSA doubling time (PSADT).
Time frame: From date of randomization until the date of first documented PSADT, assessed up to 60 months
Difference between groups regarding QoL
Time frame: At date of randomization and yearly, assessed up to 60 months
Difference between groups regarding metastasis free survival
Time frame: From date of randomization until the date of first documented date of metastases, assessed yearly by bone-scan after first PSA_progression until first sign of metastasis, whichever came first, assessed up to 100 months
Difference between groups regarding overall survival
Time frame: From date of randomization until the date of death from any cause reported yearly by the study sites up to 100 months
Difference between groups regarding cancer specific survival
Time frame: From date of randomization until date of death from prostate cancer,reported yearly by the study sites up to 100 months
Measurement of grade of toxicity of given treatments
Time frame: At date of randomization, during treatment and follow up questionaries until 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- SPCG homeLink provided by the sponsor.
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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.
Andreas Josefsson, PhD principal investigator
Univeristy of Gothenburg
Ingela Turesson, Prof principal investigator
Uppsala University
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Antiandrogen and Antiandrogen+docetaxel in people with Prostatic Neoplasms, run by Göteborg University at 5 sites in 4 countries.
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 17 inclusion and 12 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 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Finland, Denmark, Netherlands, Sweden. 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?
Progression free survival (time frame: From date of randomization until the date of first documented progression or date of death from any cause, which ever came first, assessed up to 60 months). 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 18 Aug 2021.