Clinical trial · Observational
An Alternative to A Fixed Schedule In Management Of Prostate Cancer
Testosterone-Guided Schedule of Androgen Deprivation Therapy (ADT) as an Alternative to A Fixed Schedule In Management Of Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The male sex-hormone called testosterone is known to play a key role in the growth of prostate cancer. The usual treatment for the disease involves suppression of hormones (testosterone) by anti-hormonal treatment for an unknown period of time until the cancer progresses. This anti-hormonal treatment usually consists of injections every three months with an LHRH(Leutinizing Hormone-Releasing Hormone) agonist and a short course of anti-androgen pills, which together help to lower the production of testosterone. Long-term hormonal treatment has potentially serious side effects and is expensive. In this study, hormonal treatments will be with held from those patients eligible and willing to participate. The aim of this study is to see if we can decrease the amount of hormone injections that patients require. This might lead to a decreased side effects(such as decrease in bone health, cardiovascular problems and metabolic syndrome which occurs when several health conditions happen at the same time and can lead to an increased risk of heart disease, stroke and diabetes) as well as to decrease the cost of hormonal therapy to treat prostate cancer.
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 | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- We will monitor serum testosterone initially q 6 weeks increasing to every three months and delay initiating the next dose of ADT until serum testosterone level rises above 1.5nMol/l.
- timeFrame
- Baseline, Q6wks x 24 wks
Secondary outcomes (3)
- measure
- Jamar Dynamometer
- timeFrame
- Baseline and 18 weeks
- measure
- EPIC Quality of Life Questionnaire
- timeFrame
- Baseline and 18 weeks
- measure
- Six Minute Walk Test
- timeFrame
- Baseline and 18 weeks
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * Pathological evidence of adenocarcinoma of the prostate * Have been Receiving an LHRH agonist (in the form of a 3-monthly depot) for at least 12 months * Serum testosterone level below 1.5 nMol/L (≈43 mg/dl) Exclusion Criteria: * Patients on other clinical trials needing continuous androgen deprivation
References
Publications (0)
Data not yet available