A Phase 1 interventional study of Cabazitaxel and Intensity Modulated Radiation Therapy (IMRT) in Prostate Cancer, sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-15.
Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University · Phase 1, Interventional, and Treatment
This is a single-center, open-label, non-randomized Phase I study of weekly Cabazitaxel with concurrent intensity modulated radiation therapy (IMRT) (A type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles.) and androgen deprivation therapy (Treatment to suppress or block the production or action of male hormones) in patients with locally advanced prostate cancer.
It is hoped that by adding Cabazitaxel to the standard IMRT, greater local disease control can be achieved and eventually the cure rate can be increased. After this study, the maximally tolerated dose of Cabazitaxel that could be used in combination with radiation can be found.
Men with locally advanced high risk prostate cancer represent a group of patients for whom cure is potentially achievable utilizing a multimodality approach. More aggressive treatment upfront with chemotherapy and ADT may improve the long term disease control. We hypothesize that Cabazitaxel may be added to radiation therapy safely, and we anticipate that this novel approach will improve disease control and eventually improve survival for locally advanced prostate cancer patients.
Patients with locally advanced high Gleason grade prostate cancer often have local and metastatic disease progression. To improve on these outcomes, therapy needs to be directed at controlling the androgen sensitive and insensitive prostate cancer cells in the primary and metastatic sites. This therapeutic challenge has further prompted the use of combined modality approaches incorporating chemotherapy and hormonal therapy with radiation aimed at the intrinsically resistant cells and the micrometastatic disease that are both androgen sensitive and resistant. High likelihood of occult metastatic disease and existence of intrinsically castration resistant cells are the main rationales for early institution of androgen deprivation therapy (ADT) and chemotherapy in prostate cancer.
The rationale for combining chemotherapeutic agents with ADT and radiotherapy in high risk prostate cancer patients is based on that chemotherapy can enhance radiotherapy and is also an effective therapy for metastatic castrate resistant disease. Prior studies with weekly docetaxel with ADT and intensity modulated radiation therapy (IMRT) were safe and feasible however cabazitaxel is more potent mitotic inhibitor which may further enhance the outcomes of patients with locally advanced prostate cancer.
Men with locally advanced high risk prostate cancer represent a group of patients for whom cure is potentially achievable utilizing a multimodality approach. More aggressive treatment upfront with chemotherapy and ADT would improve the long term disease control. We hypothesize that Cabazitaxel may be added to radiation therapy safely, and we anticipate that this novel approach will improve disease control and eventually improve survival for locally advanced prostate cancer patients.
The safety of the combination of Cabazitaxel with radiation will be established after this study. Potential efficacy will be determined in the future phase II/III trials. Hypofraction radiation treatment with shorter duration maybe possible if combined with chemotherapy modality.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 20 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Sidney Kimmel Cancer Center at Thomas Jefferson University is the lead sponsor of 125 studies on the registry; none are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 7 (30%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Weekly Cabazitaxel with concurrent IMRT
Drug: Cabazitaxel · Radiation: Intensity Modulated Radiation Therapy (IMRT) · Drug: Anti-Androgen Therapy: Bicalutamide · Genetic: Luteinizing Hormone-Releasing Hormone (LHRH) Agonist
Administered weekly on the same day of radiation according to the following infusion levels: Level 1 (Initial): 4 mg/m2; Level -1: 2 mg/m2; Level 2: 6 mg/m2; Level 3: 8 mg/m2; Level 4: 10 mg/2;
Also known as: Jevtana, XRP-6258
Starts 8 weeks after initiation of androgen deprivation therapy, given daily at 1.8 Gy for a total of 75.6 Gy
Also known as: Intensity Modulated Radiation Therapy, IMRT, Radiation therapy
* Taken once daily by mouth starting between 2 weeks and 1 day before the first administration of Luteinizing Hormone-Releasing Hormone (LHRH) * Will continue once daily until the final day of IMRT
Also known as: Casodex, Cosudex, Calutide, Kalumid
* First administration will occur 1 day to 2 weeks after the start of Bicalutamide and 8 weeks prior to the start of IMRT (+/- 4 weeks) * Will continue for 24 months after IMRT * Total administered duration and agent used must be documented on the case report form
Also known as: Gonadotropin-releasing hormone, GnRH, LHRH, Luliberin
Maximally Tolerated Dose (MTD) of Cabazitaxel and Intensity Modulated Radiation Therapy (IMRT)
To determine the maximally tolerated dose, or the safety and feasibility, of the concurrent weekly Cabazitaxel and IMRT with androgen deprivation therapy
Time frame: Weekly during treatment then every 3 months until 2 years after completion of IMRT
Acute and Late Non-Hematologic and Hematologic Toxicity Profile of Cabazitaxel and Intensity Modulated Radiation Therapy (IMRT) Combination
The toxicity profile will be recorded according to the NCI CTCAE v4.0 criteria. Toxicity assessment will be performed weekly during IMRT, then at 2 weeks and 3 months after IMRT, and then every 3 months until 2 years after IMRT.
Time frame: Weekly during IMRT, then at 2 weeks and 3 months after IMRT, and then every 3 months until 2 years after IMRT
5-Year Biochemical Relapse Free Survival
A PSA rise by 2 ng/mL or more above the nadir PSA is considered as biochemical relapse after external beam IMRT (ASTRO 2005 Phoenix criteria).
Time frame: Within 5 years after completion of IMRT
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sidney Kimmel Cancer Center at Thomas Jefferson University