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NCT04060043
Pilot Study to Evaluate the Effects of a Generic Goserelin Acetate in Patients With Prostate Cancer
EARLY_PHASE1 trial testing Goserelin Acetate in Prostate Cancer in 11 participants. Completed in 2 January 2018.
6 December 2017
Quick facts
| Lead sponsor | CMX Research |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 11 |
| Start date | 21 February 2017 |
| Primary completion | 6 December 2017 |
| Estimated completion | 2 January 2018 |
| Sites | 7 locations across Georgia, Canada |
Drugs / interventions tested
- Goserelin Acetate (GOSERELIN ACETATE) — full drug profile →
Conditions studied
- Prostate Cancer — all drugs for Prostate Cancer →
Sponsor
CMX Research
Who can join
18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This open-label study is designed to obtain preliminary data on the efficacy of a new depot formulation of goserelin, Pepti 10.8mg, in ambulatory patients with carcinoma of the prostate who, in the opinion of the Investigator, is a candidate for androgen deprivation therapy, after a single injection. Secondarily, it is designed to assess the pharmacokinetics, safety profile and PSA response of this new formulation.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04060043
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Goserelin Acetate
Trials testing the same drug.
- NCT07460752 — Evaluation of Alternative Site Goserelin Acetate Injection for Ovarian Function Suppression (OFS) in Local and Locally A · Phase 2 · not yet recruiting
- NCT04734730 — Talazoparib With Androgen Deprivation Therapy and Abiraterone for the Treatment of Castration Sensitive Prostate Cancer · Phase 2 · recruiting
- NCT04484818 — Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With · Phase 3 · active not recruiting
- NCT04423211 — Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging · Phase 3 · recruiting
- NCT04203212 — BMD Alterations and Bone and Muscle Parameters During Menstrual Cessation With GnRH · completed
Other recruiting trials for Prostate Cancer
Currently open trials in the same condition.
- NCT06960798 — Characterizing the Genomic Landscape of Prostate Cancer in Native American Populations (NAT-Geno) · recruiting
- NCT07237269 — Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer · Phase 2 · recruiting
- NCT07234981 — PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Recurrent Prostate Cancer · Phase 2 · recruiting
- NCT07027124 — Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Ris · Phase 2 · recruiting
- NCT07426094 — PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate · Phase 2, PHASE3 · recruiting
Other CMX Research trials
Trials by the same sponsor.
- NCT04165408 — Trial to Assess the Safety and Clinical Performance of Contino® in Preventing Urinary Incontinence · NA · suspended
- NCT03605459 — Trial to Assess the Efficacy of the Comfort Plug™in Preventing Urinary Incontinence (COMFORT STUDY) · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04060043 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by CMX Research
- Last refreshed: 10 May 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04060043.
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