A Phase 4 interventional study of Decapeptyl® SR 22.5mg and Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg in Prostate Cancer, sponsored by Ipsen. Terminated at 35 sites in United Kingdom. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-23.
Sponsored by Ipsen · Phase 4, Interventional, and Treatment
The purpose of this study is to demonstrate that treatment with a 6-monthly injection of hormone therapy is as good and as well tolerated as the standard 3-monthly hormone therapy injections available for treating prostate cancer. The study will also aim to answer whether both doctors and patients would prefer treatment with a 6-monthly injection rather than injections every 3 months.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 27 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Ipsen is the lead sponsor of 282 studies on the registry; 16 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
In addition:
For patients with metastatic prostate cancer (M+) and a Gleason score
≤ 7, LHRH agonist injection (any formulation) must have been initiated within the last 2 years from Baseline,
Exclusion Criteria:
Drug: Decapeptyl® SR 22.5mg
One of the following: Decapeptyl® SR 11.25mg (Triptorelin), Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg
Drug: Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg
22.5mg, intramuscular injection, given on day 1 / month 0 \& month 6 (+/- 7 days).
Also known as: Triptorelin
For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall
Also known as: Triptorelin
Percentage of Participants Maintaining Biochemical Castration
Patients with serum total testosterone (STT) level lower than 0.5 ng/mL after 6 months of treatment.
Time frame: 6 months
Percentage of Participants Maintaining Biochemical Castration After 12 Months of Treatment.
Patients with serum total testosterone (STT) level lower than 0.5 ng/mL, 12 months after randomisation..
Time frame: 12 months
Percentage of Participants Demonstrating Stable Prostate-specific Antigen (PSA) Levels
Stable PSA level was noted as value either lower or less than 25% higher than the baseline value, or PSA value ≤0.5 ng/mL higher than the baseline value, if value ≥25% higher than the baseline value.
Time frame: 6 and 12 months
Change From Baseline in Quality of Life Using EuroQol 5 Dimensions 5 Levels [EQ-5D-5L] Questionnaire.
The EQ-5D-5L questionnaire consisted of a description of raw data which comprised of five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension had five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The visual analogical scale of the EQ-5D-5L questionnaire was numbered from 0 to 100 (0 meaning the worst health the patient can imagine and 100 the best health the patient can imagine).
Time frame: Baseline and Month 12
Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II)
TSQM comprised of four dimensions: effectiveness, side effects, convenience and overall global satisfaction. Each score ranged from 0 to 100. For effectiveness, convenience and overall global satisfaction scores, 0 indicated an extreme dissatisfaction and 100 indicated an extreme satisfaction. For side effects score, 0 indicated an extreme dissatisfaction and 100 indicated no dissatisfaction at all.
Time frame: 6 and 12 month
Patient Satisfaction With Treatment.
Using a non-validated study-specific descriptive Likert-type scale (with no units) comprising a simple six-question patient questionnaire.
Time frame: Month 12
Percentage of Participants Who Changed Injection Frequency After Completion of the Study
Time frame: Month 12
35 subjects screened and 27 subjects were enrolled. Following enrollment, 21 patients were randomised before the study was prematurely discontinued.
| Milestone | Decapeptyl® SR 22.5mg | Current 3-monthly LHRH Agonist |
|---|---|---|
| Started | 14 | 7 |
| Completed | 4 | 1 |
| Not completed | 10 | 6 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Study termination | 9 | 6 |
Patients with serum total testosterone (STT) level lower than 0.5 ng/mL after 6 months of treatment.
| percentage of participants | Decapeptyl® SR 22.5mg | Current 3-monthly LHRH Agonist |
|---|---|---|
| Percentage of Participants Maintaining Biochemical Castration | 92.9 | 100 |
Patients with serum total testosterone (STT) level lower than 0.5 ng/mL, 12 months after randomisation..
| percentage of participants | Decapeptyl® SR 22.5mg | Current 3-monthly LHRH Agonist |
|---|---|---|
| Percentage of Participants Maintaining Biochemical Castration After 12 Months of Treatment. | 22.2 | 25.0 |
Stable PSA level was noted as value either lower or less than 25% higher than the baseline value, or PSA value ≤0.5 ng/mL higher than the baseline value, if value ≥25% higher than the baseline value.
| percentage of participants | Decapeptyl® SR 22.5mg | Current 3-monthly LHRH Agonist |
|---|---|---|
| 6 months (n = 13, 7) | 84.6 | 100 |
| 12 months (n = 2, 1) | 50 | 100 |
The EQ-5D-5L questionnaire consisted of a description of raw data which comprised of five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension had five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The visual analogical scale of the EQ-5D-5L questionnaire was numbered from 0 to 100 (0 meaning the worst health the patient can imagine and 100 the best health the patient can imagine).
| units on a scale | Decapeptyl® SR 22.5mg | Current 3-monthly LHRH Agonist |
|---|---|---|
| Change From Baseline in Quality of Life Using EuroQol 5 Dimensions 5 Levels [EQ-5D-5L] Questionnaire. | 71.7 (40.4 to 102.9) | 70.0 (-57.1 to 197.1) |
TSQM comprised of four dimensions: effectiveness, side effects, convenience and overall global satisfaction. Each score ranged from 0 to 100. For effectiveness, convenience and overall global satisfaction scores, 0 indicated an extreme dissatisfaction and 100 indicated an extreme satisfaction. For side effects score, 0 indicated an extreme dissatisfaction and 100 indicated no dissatisfaction at all.
| units on a scale | Decapeptyl® SR 22.5mg | Current 3-monthly LHRH Agonist |
|---|---|---|
| Baseline to 6 months - Effectiveness (n= 13, 7) | 3.2 (-12.5 to 18.9) | 13.1 (-10.8 to 37.0) |
| Baseline to 12 months - Effectiveness (n= 3, 2) | -33.3 (-74.7 to 8.1) | -12.5 (-383.1 to 358.1) |
| Baseline to 6 months - Side Effects (n= 13, 7) | -2.6 (-12.9 to 7.8) | 4.8 (-6.0 to 15.5) |
| Baseline to 12 months - Side Effects (n= 3, 2) | -25.0 (-115.2 to 65.2) | 12.5 (-146.3 to 171.3) |
| Baseline to 6 months - Convenience (n= 13, 7) | 4.7 (-6.3 to 15.7) | 2.0 (-9.8 to 13.7) |
| Baseline to 12 months - Convenience (n= 3, 2) | -1.9 (-36.6 to 32.9) | 2.8 (-103.1 to 108.7) |
| Baseline to 6months -Global Satisfaction(n= 12, 6) | -0.7 (-15.9 to 14.5) | -4.2 (-11.5 to 3.2) |
| Baseline to 12months -Global Satisfaction(n= 2, 2) | -12.5 (-171.3 to 146.3) | 4.2 (-48.8 to 57.1) |
Using a non-validated study-specific descriptive Likert-type scale (with no units) comprising a simple six-question patient questionnaire.
No measurements were reported for this outcome.
| percentage of participants | Decapeptyl® SR 22.5mg | Current 3-monthly LHRH Agonist |
|---|---|---|
| Percentage of Participants Who Changed Injection Frequency After Completion of the Study | 80 | 0 |
Collected over Up to 12 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Decapeptyl® SR 22.5mg | — | 2/14 (14.3%) | 12/14 (85.7%) |
| Current 3-monthly LHRH Agonist | — | 0/7 (0%) | 7/7 (100%) |
| Event | Decapeptyl® SR 22.5mg | Current 3-monthly LHRH Agonist |
|---|---|---|
| PneumoniaInfections and infestations | 1/14 | 0/7 |
| Subdural haematomaInjury, poisoning and procedural complications | 1/14 | 0/7 |
| Disease progressionGeneral disorders | 1/14 | 0/7 |
| Event | Decapeptyl® SR 22.5mg | Current 3-monthly LHRH Agonist |
|---|---|---|
| DizzinessNervous system disorders | 5/14 | 0/7 |
| Lower respiratory tract infectionInfections and infestations | 3/14 | 1/7 |
| Back painMusculoskeletal and connective tissue disorders | 3/14 | 1/7 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 3/14 | 0/7 |
| Oedema peripheralGeneral disorders | 2/14 | 0/7 |
| BronchitisInfections and infestations | 1/14 | 1/7 |
| Urinary tract infectionInfections and infestations | 2/14 | 0/7 |
| HeadacheNervous system disorders | 2/14 | 0/7 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 2/14 | 0/7 |
| CoughRespiratory, thoracic and mediastinal disorders | 2/14 | 0/7 |
| Age, Continuous(years) | Decapeptyl® SR 22.5mg | Current 3-monthly LHRH Agonist | Total |
|---|---|---|---|
| Mean | 77.2 ± 5.4 | 78.7 ± 9.3 | 77.7 ± 6.7 |
| Sex: Female, Male(Participants) | Decapeptyl® SR 22.5mg | Current 3-monthly LHRH Agonist | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 14 | 7 | 21 |
| Employment status/Occupation(participants) | Decapeptyl® SR 22.5mg | Current 3-monthly LHRH Agonist | Total |
|---|---|---|---|
| Employed | 2 | 1 | 3 |
| Retired | 12 | 6 | 18 |
This study is terminated, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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