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NCT04424654: PSMA-BAT
Biomarker Analysis of Castration-resistant Prostate Cancer Undergoing Bipolar Androgen Therapy
Phase 2 trial testing Testosterone cypionate in Prostate Cancer in 20 participants. Completed in 1 July 2022.
1 May 2022
Quick facts
| Lead sponsor | Hospital Sirio-Libanes |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 22 September 2020 |
| Primary completion | 1 May 2022 |
| Estimated completion | 1 July 2022 |
| Sites | 2 locations across Brazil |
Drugs / interventions tested
- Testosterone cypionate — full drug profile →
Conditions studied
- Prostate Cancer — all drugs for Prostate Cancer →
Sponsor
Hospital Sirio-Libanes
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 is an open label phase II, single-arm, biomarker multi-institutional pilot study. Men with progressive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen deprivation therapy (ADT) and at least one prior second generation AR-targeted therapy (either abiraterone or enzalutamide) will be enrolled in this study. All patients will receive treatment with testosterone cypionate 400 mg, intramuscular, every 28 days for a maximum of 3 cycles or limiting toxicity, if it occurs before the end of the scheduled therapy. After 3 cycles of BAT (12 weeks), patients may continue receiving this therapy off study at the discretion of the treating physician, if clinical/radiographic benefit. During the study period, patients will have plasma collected for cell-free tumor DNA analysis and CTC ARV7 status and also will perform 68Gallium-PSMA PET at baseline and then every 6 weeks.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Detection of Early Progression with <sup>18</sup>F-DCFPyL PET/CT in Men with Metastatic Castration-Resistant Prostate Cancer Receiving Bipolar Androgen Therapy.
Markowski MC, Velho PI, Eisenberger MA, Pomper MG, et al · · 2021 · cited 8× · PMID 33452039 · DOI 10.2967/jnumed.120.259226 -
Exploring the clinical utility of liquid biopsy with cfDNA in cancer: A systematic review.
Ranganathan K, Kurian NS, Goswami HM, Rishi KD, et al · · 2024 · cited 5× · PMID 40027943 · DOI 10.1016/j.jlb.2024.100150 -
Bipolar Androgen Therapy: When Excess Fuel Extinguishes the Fire.
Nabavi N, Mahdavi SR, Ardalan MA, Chamanara M, et al · · 2023 · cited 5× · PMID 37509723 · DOI 10.3390/biomedicines11072084 -
Improving computational drug repositioning through multi-source disease similarity networks.
Le DH. · · 2025 · cited 1× · PMID 40841559 · DOI 10.1038/s41598-025-04772-0
Verify or expand the search:
- PubMed search for NCT04424654
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Testosterone cypionate
Trials testing the same drug.
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- NCT07142551 — Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response · Phase 2 · recruiting
- NCT06922318 — The COSMYC Trial (COmbined Suppression of MYC) · Phase 2 · recruiting
- NCT06111209 — The Anabolic Effect of Testosterone on Pelvic Floor Muscles · Phase 2 · recruiting
- NCT03554317 — COMbination of Bipolar Androgen Therapy and Nivolumab · Phase 2 · 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 Hospital Sirio-Libanes trials
Trials by the same sponsor.
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- NCT06479031 — Occupational Therapy Intervention on the Prevention of Delirium and Occupational Performance Status in Elderly Patients · NA · not yet recruiting
- NCT06339632 — Effects of Transcutaneous Electrical Phrenic Nerve Stimulation and Transcutaneous Electrical Diaphragmatic Stimulation · NA · recruiting
- NCT05950269 — Walking Aid and Locomotion Knowledge in Emergency Rooms (WALKER 1) for Elderly People · NA · completed
- NCT05840458 — Pericapsular Nerve Block in Proximal Femoral Fractures · unknown
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 NCT04424654 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital Sirio-Libanes
- Last refreshed: 3 August 2022
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/NCT04424654.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing