Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2025-12-29 @ 7:09 AM
Study NCT ID:
NCT01420250
Status:
COMPLETED
Last Update Posted:
2025-05-15
First Post:
2011-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cabazitaxel With Radiation and Hormone Therapy for Prostate Cancer
Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Organization:
Study Overview
Official Title:
Phase I Trial of Weekly Cabazitaxel With Concurrent Intensity Modulated Radiation Therapy and Androgen Deprivation Therapy for the Treatment of Locally Advanced High Risk Adenocarcinoma of the Prostate
Status:
COMPLETED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: