Clinical trial · Interventional
Firmagon (Degarelix) Intermittent Therapy
Randomized, Multicentre Efficacy and Safety Study Comparing 10 Mons vs 4 Mons Degarelix Therapy in Prolonging the Off Treatment Interval in Men With Localized Prostate Cancer Receiving Intermittent ADT for Biochemical Recurrence Following Radical Local Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): acrrual target was not being met
Summary
Brief summary (as posted)
Men with localized prostate cancer requiring intermittent androgen deprivation therapy for biochemical recurrence following radical therapy will be asked to participate in a phase 4 safety and efficacy clinical trial comparing 10 months versus 4 months of degarelix (Firmagon®) therapy with the endpoint of prolonging the off treatment interval.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer Recurrent | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| degarelix | Drug | Degarelix | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 10 month degarelix therapy
- interventionNames
- Drug: degarelix
- type
- ACTIVE_COMPARATOR
- label
- 4 month degarelix therapy arm
- interventionNames
- Drug: degarelix
Primary outcomes (1)
- measure
- serum PSA
- timeFrame
- approximately 15 months
- description
- The study will compare the length of the off treatment interval (in months) of subjects in the 4 month arm vs those in the 10 month arm. The off treatment interval is defined as the time from PSA nadir following completion of hormone therapy in both arms until the time PSA reaches 5.0ng/ml
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * histologically confirmed adenocarcinoma of the prostate for which intermittent endocrine treatment therapy is indicated * PSA level meeting both of these criteria: * PSA level of ≥ 5 ng/mL. * For patients with recurrence after radiotherapy or cryotherapy: Patients should have a serum PSA (two measurements) to be \>2 ng/mL higher than a previously confirmed PSA nadir. * screening serum testosterone level above the lower limit of normal range defined as \>2.2 ng/mL. Exclusion Criteria: * Has had previous or is currently under hormonal management of prostate cancer (surgical castration or other hormonal manipulation) * Has received therapy with the 5-alpha reductase inhibitors finasteride or dutasteride within 12 weeks and 25 weeks, respectively, prior to screening
References
Publications (0)
Data not yet available