Oral Docetaxel (ModraDoc/r) in Combination With Hormonal Treatment and Radiation Therapy in High-… (NCT03066154) | Clinical Trial Compass
TerminatedPhase 1
Oral Docetaxel (ModraDoc/r) in Combination With Hormonal Treatment and Radiation Therapy in High-risk Prostate Cancer
Stopped: low inclusion of patients and availability of the IP
Netherlands24 participantsStarted 2016-09
Plain-language summary
The optimal treatment for HRPC patients has not yet been established. Recent trials suggest a benefit from early treatment with docetaxel in the castration-sensitive setting, with an improvement in failure free survival in high risk and metastatic patients and increase in overall survival in the metastatic hormone-sensitive group. In these recent randomized controlled trials, patients were treated with hormonal therapy and radiotherapy and adjuvant docetaxel, assuming that early systemic treatment for high risk or metastatic disease could delay progression in patients with aggressive primary tumor characteristics.
With the fact that docetaxel is a known radiosensitizer, combined modality treatment with docetaxel during the radiotherapy could also lead to better local control and reduction of local recurrence. Several phase I and II studies have been done in HRPC patients, to evaluate the combination of high dose radiotherapy and concurrent weekly infusions with docetaxel.
Oral administration of docetaxel has many advantages above intravenously administered drugs for patients. Besides the higher patient convenience, possibly longer treatment duration can be achieved due to better safety. Frequently occurring toxicities of intravenously administered docetaxel, such as neutropenia, hypersensitivity reactions and peripheral polyneuropathy have rarely been observed with the oral docetaxel formulation ModraDoc006/r.
The primary aim of the N15DOP study is to determine the maximum tolerable dose (MTD) of ModraDoc006/r when given in a weekly bidaily schedule in combined modality with high dose intensity radiotherapy and hormonal therapy in castration-sensitive prostate cancer patients with high risk disease, including positive lymph nodes.
Who can participate
Age range18 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Histologically proven prostate cancer.
✓. All eligible patients have hormone naïve non-metastatic node positive high risk prostate cancer. Node positive cancer will be defined as radiological demonstration of more than four pelvic lymph node(s) consisting of bean shaped lymph node(s) with a short axis of minimal 10 mm and/or round lymph node(s) with a minimal size of 8 mm on PSMA, MRI or CT scan.
✓. High risk prostate cancer will be defined as node positive with all of the following primary tumour characteristics: Tumour stage ≥cT2c and Gleason score ≥4+3, any PSA
✓. Age ≥ 18 years
✓. No signs of metastatic disease on standard diagnostic scans.
✓. Normal serum testosterone levels prior to treatment
✓. Adequate haematological, renal and hepatic functions
✓. Haemoglobin ≥ 6.0 mmol/l
Exclusion criteria
✕. Any treatment with investigational drugs, chemotherapy or immunotherapy within 30 days prior to receiving the first dose of investigational treatment; Patients may be on ADT as long as this is has not been longer than 4 weeks prior the start of the radiotherapy.
What they're measuring
1
Maximal tolerated dose (MTD) of ModraDoc/r in the combination treatment
✕. Patients who have had prior pelvic radiation therapy
✕. Patients who have had prior treatment with taxanes
✕. TURP within 3 months before start of the study
✕. Patients who have had a prostatectomy.
✕. Any contra-indication for MRI
✕. Major difficulties for marker implantation
✕. Unreliable contraceptive methods. Men enrolled in this trial must agree to use a reliable contraceptive method throughout the study (adequate contraceptive methods are: condom, sterilization)