Neoplasm, ProstatePhase 3NCT01819285
Early Compared With Delayed Hormone Therapy in Treating Patients With Nonmetastatic Prostate Cancer
A Phase 3 study testing Immediate Orchiectomy or depot LHRH and Delayed Orchiectomy or depot LHRH in people with Neoplasm, Prostate, run by European Organisation for Research and Treatment of Cancer - EORTC.
Trial summary
Objectives I. Compare, in a randomized Phase III multi-institutional setting, symptom-free survival time of patients with asymptomatic carcinoma of the prostate (T0-4, N0-2, M0) not suited for local curative treatment who are randomly assigned to immediate vs. Read more about this study
- Who is it for?
- Ages Up to 80 years, men only
- Conditions the study is for
- Neoplasm, Prostate
- What is being tested?
- Immediate Orchiectomy or depot LHRH and Delayed Orchiectomy or depot LHRH
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 985 participants
- Where
- No sites listed yet
- Study dates
- Feb 1990to Sep 2010
- 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 Up to 80 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically or cytologically proven, newly diagnosed asymptomatic (with the exception of voiding disturbances) carcinoma of the prostate T0-4 N0-2 M0 which is not suitable for local treatment with curative intent (radical prostatectomy, radiation therapy).
- All T stages are acceptable (UICC 1982). The stage is determined by rectal palpation.
- Patients with regional lymph node metastases smaller than 5 cm (N0-2), determined either by CT or ultrasonography, preferable with cytologic confirmation.
- Life expectancy of at least six months.
- WHO performance status score 0-1.
- Informed consent. Patients must be prepared to undergo an orchiectomy or continuous treatment with a depot LHRH analogue.
- Continuous follow-up until death if possible.
Who cannot join
- Other malignancies diagnosed during the last 10 years, apart from treated basal cell carcinoma of the skin.
- Prostate cancer known for longer than one month before entering the study.
- Pain caused by the prostate cancer or its metastases.
- Any previous treatment for prostate cancer (radical prostatectomy, radiation therapy, endocrine treatment, etc.) Note: TUR-P for voiding disturbances is allowed at any time and is not an exclusion criterion.
- Patients with ureteric obstruction caused by local infiltration of prostatic cancer and other evidence of locally advanced disease which could cause fatal complications if untreated (e.g. rectal stenosis, thrombosis of pelvic veins).
- Patients with palpable or juxtaregional lymph node metastasis (paraaortic, supraclavicular, inguinal, N3-4).
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- Patients with evidence of distant metastases (bone, lung, liver).
- Age over 80 years. Performance status WHO score 2, 3 and 4 (any reason).
- Patient who refuses orchiectomy or longterm subcutaneous implants of LHRH analogue in two monthly intervals.
- Expected difficulties with follow-up for any reason.
About this study
Official title: Phase III Comparison of Early vs Delayed Endocrine Manipulation (Orchiectomy or LHRH Agonist Therapy) in Previously Untreated Patients With Nonmetastatic Asymptomatic Carcinoma of the Prostate
Objectives
- Compare, in a randomized Phase III multi-institutional setting, symptom-free survival time of patients with asymptomatic carcinoma of the prostate (T0-4, N0-2, M0) not suited for local curative treatment who are randomly assigned to immediate vs. delayed endocrine intervention (orchiectomy or luteinizing hormone releasing hormone (LHRH) agonist therapy).
Read more
II. Compare the overall survival of these two groups of patients.
III. Compare the time to first evidence of distant progression (N4 or M1) of these two treatment groups.
IV. Evaluate the prognostic significance of pretreatment laboratory data and monitor these parameters following endocrine therapy.
- Study the prognosis of various sub-groups of patients stratified according to performance status, local tumor extent, nodal status, and choice of endocrine treatment.
- Conditions
- Neoplasm, Prostate
- Being tested
- Immediate Orchiectomy or depot LHRH, Delayed Orchiectomy or depot LHRH
- Keywords
- Malignant Neoplasm of Prostate, Tumor-node-metastasis (TNM) Staging Regional Lymph Nodes (N0-2), Not suitable for local treatment with curative intent
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate Orchiectomy or depot LHRHProcedure or surgery
Delayed Orchiectomy or depot LHRHProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Immediate Endocrine Therapy | Active comparator | Immediate Endocrine Therapy. Orchiectomy or LHRH Agonist Therapy plus (initially) Antiandrogen Therapy. Buserelin (BSRL); Cyproterone acetate (Androcur) (CPTR), Cyproterone acetate (Androcur)(NSC-81430). Treatment initiated within 1 month of randomization. Receives: Procedure: Immediate Orchiectomy or depot LHRH |
| Delayed Endocrine Therapy | Experimental | Orchiectomy or LHRH Therapy plus (initially) Antiandrogen Therapy. BSRL; CPTR. Treatment delayed until onset of symptoms. Receives: Procedure: Delayed Orchiectomy or depot LHRH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 13 years from first patient in
Secondary outcomes (4)
Overall symptom free survival time
Measured: 13 years from first patient in
Time until first evidence of distant progression
Measured: 13 years from first patient in
Prognostic importance of pretreatment laboratory data
prostate cancer mortality and overall mortality according to pretreatment laboratory data
Measured: 13 years from first patient in
Prognosis of particular sub-groups
prostate cancer mortality and overall mortality according to particular sub-groups (following stratification factors): performance status (0 vs 1), the local tumor extent (T0-2 vs T3-4), nodal status (N0 vs N1-2), the choice of hormonal therapy.
Measured: 13 years from first patient in
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startFeb 1990
- Primary completionJul 2004
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neoplasm, ProstateStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe 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
- 985 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Urs Studer, MD, Study chair, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819285
- Sponsor's protocol ID
- EORTC-30891
- Status last verified
- Mar 2013
- First submitted
- 18 Mar 2013
- Last updated
- 27 Mar 2013
- Results posted
- No
Publications
Studer UE, Whelan P, Wimpissinger F, Casselman J, de Reijke TM, Knonagel H, Loidl W, Isorna S, Sundaram SK, Collette L; EORTC Genitourinary Cancer Group. Differences in time to disease progression do not predict for cancer-specific survival in patients receiving immediate or deferred androgen-deprivation therapy for prostate cancer: final results of EORTC randomized trial 30891 with 12 years of follow-up. Eur Urol. 2014 Nov;66(5):829-38. doi: 10.1016/j.eururo.2013.07.024. Epub 2013 Jul 24.
PubMed 23932338
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Comparison of Early vs Delayed Endocrine Manipulation (Orchiectomy or LHRH Agonist Therapy) in Previously Untreated Patients With Nonmetastatic Asymptomatic Carcinoma of the Prostate
- ClinicalTrials.gov ID
- NCT01819285
- Acronym / sponsor ID
- EORTC-30891
- Conditions
- Neoplasm, Prostate
- Keywords
- Malignant Neoplasm of Prostate, Tumor-node-metastasis (TNM) Staging Regional Lymph Nodes (N0-2), Not suitable for local treatment with curative intent
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 985 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Feb 1990
- Primary completion
- Jul 2004 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 27 Mar 2013 (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.
Objectives
- Compare, in a randomized Phase III multi-institutional setting, symptom-free survival time of patients with asymptomatic carcinoma of the prostate (T0-4, N0-2, M0) not suited for local curative treatment who are randomly assigned to immediate vs. delayed endocrine intervention (orchiectomy or luteinizing hormone releasing hormone (LHRH) agonist therapy).
II. Compare the overall survival of these two groups of patients.
III. Compare the time to first evidence of distant progression (N4 or M1) of these two treatment groups.
IV. Evaluate the prognostic significance of pretreatment laboratory data and monitor these parameters following endocrine therapy.
- Study the prognosis of various sub-groups of patients stratified according to performance status, local tumor extent, nodal status, and choice of endocrine treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Endocrine Therapy | Active comparator | Procedure: Immediate Orchiectomy or depot LHRHImmediate Endocrine Therapy. Orchiectomy or LHRH Agonist Therapy plus (initially) Antiandrogen Therapy. Buserelin (BSRL); Cyproterone acetate (Androcur) (CPTR), Cyproterone acetate (Androcur)(NSC-81430). Treatment initiated within 1 month of randomization. |
| Delayed Endocrine Therapy | Experimental | Procedure: Delayed Orchiectomy or depot LHRHOrchiectomy or LHRH Therapy plus (initially) Antiandrogen Therapy. BSRL; CPTR. Treatment delayed until onset of symptoms. |
Who may qualify
- Ages
- Up to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically proven, newly diagnosed asymptomatic (with the exception of voiding disturbances) carcinoma of the prostate T0-4 N0-2 M0 which is not suitable for local treatment with curative intent (radical prostatectomy, radiation therapy).
- All T stages are acceptable (UICC 1982). The stage is determined by rectal palpation.
- Patients with regional lymph node metastases smaller than 5 cm (N0-2), determined either by CT or ultrasonography, preferable with cytologic confirmation.
- Life expectancy of at least six months.
- WHO performance status score 0-1.
Key exclusion criteria (10 listed)
- Other malignancies diagnosed during the last 10 years, apart from treated basal cell carcinoma of the skin.
- Prostate cancer known for longer than one month before entering the study.
- Pain caused by the prostate cancer or its metastases.
- Any previous treatment for prostate cancer (radical prostatectomy, radiation therapy, endocrine treatment, etc.) Note: TUR-P for voiding disturbances is allowed at any time and is not an exclusion criterion.
- Patients with ureteric obstruction caused by local infiltration of prostatic cancer and other evidence of locally advanced disease which could cause fatal complications if untreated (e.g. rectal stenosis, thrombosis of pelvic veins).
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 |
|---|---|---|
| Immediate Orchiectomy or depot LHRH | Procedure or surgery | Immediate Endocrine Therapy |
| Delayed Orchiectomy or depot LHRH | Procedure or surgery | Delayed Endocrine Therapy |
Primary outcome
Overall survival
Time frame: 13 years from first patient in
4 secondary outcomes
Overall symptom free survival time
Time frame: 13 years from first patient in
Time until first evidence of distant progression
Time frame: 13 years from first patient in
Prognostic importance of pretreatment laboratory data
Time frame: 13 years from first patient in
Prognosis of particular sub-groups
Time frame: 13 years from first patient in
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2013.
- Derived from this study: PubMed 23932338Studer UE, Whelan P, Wimpissinger F, Casselman J, de Reijke TM, Knonagel H, Loidl W, Isorna S, Sundaram SK, Collette L; EORTC Genitourinary Cancer Group. Differences in time to disease progression do not predict for cancer-specific survival in patients receiving immediate or deferred androgen-deprivation therapy for prostate cancer: final results of EORTC randomized trial 30891 with 12 years of follow-up. Eur Urol. 2014 Nov;66(5):829-38. doi: 10.1016/j.eururo.2013.07.024. Epub 2013 Jul 24.
- Related InfoLink 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.
Urs Studer, MD study chair
Insel Gruppe AG, University Hospital Bern
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Immediate Orchiectomy or depot LHRH and Delayed Orchiectomy or depot LHRH in people with Neoplasm, Prostate, run by European Organisation for Research and Treatment of Cancer - EORTC.
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 7 inclusion and 10 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: finished, as of the sponsor's last update on 27 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall survival (time frame: 13 years from first patient in). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01819285, which also lists 1 linked publication.
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 27 Mar 2013.