Clinical trial · Interventional
Docetaxel in Treating Patients With Relapsed Prostate Cancer
Phase II Study of the Early Use of Docetaxel in Patients With Biochemical Relapse After Primary Therapy for Prostate Cancer and an Incomplete Response to Androgen Deprivation 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): Drug supplier stopped funding due to loss of study drug (docetaxel) patent.
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well docetaxel works in treating patients with relapsed 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of Participants With a Complete Response as Measured by Serum PSA Less Than 0.2 ng/ml
- timeFrame
- While receiving study treatment (approximately 6 months)
- description
- Complete response rate, as measured by PSA and defined as a PSA ≤0.2 ng/ml in PSA-relapsed, hormone-sensitive patients treated with docetaxel.
Secondary outcomes (4)
- measure
- Average Time for Participants to Develop PSA Recurrence (PSA > 0.2ng/ml)
- timeFrame
- Average days to develop recurrence from treatment start date amount applicable participants
- description
- Average time for participants to develop PSA recurrence (PSA \> 0.2ng/ml). Due to the limited enrollment, this analysis was not completed.
- measure
- Time to Metastatic Disease
- timeFrame
- Measured at Time of documented metastases (no historical estimate is available)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Criteria for Patient eligibility Inclusion criteria 1. Histologically confirmed adenocarcinoma of the prostate. 2. Prior primary therapy for prostate cancer, including radical prostatectomy, external beam radiation therapy, or brachytherapy. 3. Serum PSA \> 0.2 ng/dL following 8 months of androgen deprivation therapy or a nadir PSA \>0.2 ng/dL and at least 1 subsequent PSA values at the same or higher level, if prior to 8 months. 4. Serum testosterone \< 50 ng/ml. 5. No evidence of metastases on bone scan. 6. No evidence of metastases on CT scan of the abdomen and pelvis. 7. ECOG performance status \< 2. 8. Laboratory criteria for entry: absolute neutrophil count ≥ 1.2 K/cu mm, platelets ≥ 100 K/cu mm, serum bilirubin ≤ upper limit of normal (ULN), SGOT and SGPT ≤ 1.5 times institutional ULN if alkaline phosphatase ≤ ULN, alkaline phosphatase ≤ 5 times ULN if SGOT and SGPT are ≤ ULN, a serum creatinine ≤ 2 times institutional ULN. 9. Signed informed consent. Exclusion Criteria 1. A second active malignancy during the last 5 years, except adequately treated non-melanoma skin cancer. 2. Life expectancy \< 3 months. 3. Grade 2 or higher peripheral neuropathy. 4. Prior investigational agent within the past 28 days. 5. Less than a 10% decrease (or continued rise) in PSA in response to initial androgen-deprivation therapy. 6. More than 12 months since initiation of androgen-deprivation therapy. 7. Prior docetaxel chemotherapy. 8. Patients recently (within 28 days) started on corticosteroids, with the exception of inhaled and topical steroids. Patients on stable doses of systemic corticosteroids will be eligible.
References
Publications (0)
Data not yet available