Clinical trial · Interventional
Testosterone in Treating Patients With Progressive Prostate Cancer That No Longer Responds to Hormone Therapy
A Phase I Trial of Testosterone in Patients With Progressive Androgen-Independent Prostate Cancer
NCT00006044CI-TRIAL-00009015completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
RATIONALE: High doses of testosterone may be effective in killing prostate cancer cells that no longer respond to hormone therapy. PURPOSE: Phase I trial to study the effectiveness of testosterone in treating patients who have progressive prostate cancer that no longer responds to hormone therapy.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| therapeutic testosterone | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed androgen independent metastatic prostate cancer * Progressive disease manifested by either: * New osseous lesions by bone scan or a greater than 25% increase in bidimensionally measurable soft tissue disease or the appearance of new sites of disease by MRI or CT scan OR * Minimum of 3 rising PSA values from baseline that are obtained 1 week or more apart, or 2 rising PSA values more than 1 month apart, where the percentage increase over the range of values is at least 25% * Castrate state by orchiectomy or gonadotropin-releasing hormone analogues for minimum of 1 year * Testosterone no greater than 30 ng/mL * Measurable disease * Metastatic disease by bone scan, MRI, or CT scan * Rising PSA values * If receiving antiandrogen therapy, must have shown progressive disease off treatment * No active CNS or epidural tumor PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * WBC at least 3,500/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * Bilirubin less than 2.0 mg/dL * SGOT less than 3 times upper limit of normal * PTT less than 14 seconds Renal: * Creatinine less than 2.0 mg/dL OR * Creatinine clearance greater than 60 mL/min Cardiovascular: * No New York Heart Association class III or IV cardiac disease Pulmonary: * No severe debilitating pulmonary disease Other: * No infection requiring IV antibiotics * No other severe medical problems that would increase risk for toxicity PRIOR CONCURRENT THERAPY: Biologic therapy: * Recovered from prior biologic therapy * No concurrent immunotherapy Chemotherapy: * Recovered from prior chemotherapy * No concurrent chemotherapy Endocrine therapy: * See Disease Characteristics * If no prior orchiectomy, must continue on gonadotropin-releasing hormone analogs to maintain castrate levels of testosterone * No concurrent finasteride * No other concurrent hormonal therapy Radiotherapy: * Recovered from prior radiotherapy * No concurrent radiotherapy to an indicator lesion Surgery: * See Disease Characteristics * Recovered from prior surgery * No concurrent surgery on only measurable lesion Other: * At least 4 weeks since other prior investigational anticancer drugs and recovered * No other concurrent investigational anticancer agents
References
Publications (1)
- RESULTMorris MJ, Huang D, Kelly WK, Slovin SF, Stephenson RD, Eicher C, Delacruz A, Curley T, Schwartz LH, Scher HI. Phase 1 trial of high-dose exogenous testosterone in patients with castration-resistant metastatic prostate cancer. Eur Urol. 2009 Aug;56(2):237-44. doi: 10.1016/j.eururo.2009.03.073. Epub 2009 Apr 3. PMID 19375217