Docetaxel, Androgen Deprivation and Proton Therapy for High Risk Prostate Cancer

Prostate Cancer Clinical Trial

— PR05  

Official title:

A Phase II Study of Proton-Based Radiation Therapy With Elective Pelvic Nodal Irradiation, Concomitant Docetaxel, and Adjuvant Androgen Deprivation for High-Risk Prostate Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01040624
• Other study ID #: UFPTI 0703 - PR05
• Secondary ID: IRB201702459
• Status: Completed
• Phase: N/A
• Start date: December 2009
• Est. completion date: April 11, 2022

Study information

• Verified date: September 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to see what effects, good and/or bad, proton based radiation combined with low dose chemotherapy and hormonal therapy, has on patients and their cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: April 11, 2022
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adenocarcinoma of the prostate.

Exclusion Criteria:

• Previous prostate cancer treatment such as chemotherapy and/or pelvic radiation.

• Active inflammatory bowel disease (diverticulitis, Crohn's disease or ulcerative colitis) affecting the rectum. (Non-active diverticulitis and Crohn's disease not affecting the rectum are allowed.)

• History of hip replacement.

• Prior intrapelvic surgery. This includes the following:

• Transrectal or rectal surgery other than polypectomy or hemorrhoid removal or banding

• Transabdominal pelvic surgery

• Bladder surgery

• Prior myocardial infarction (MI) or congestive heart failure (CHF).

• Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• < 15% risk of + LN
Total of 54 Cobalt gray equivalent (CGE) over 30 treatments to prostate + seminal vesicles (SV), then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during radiation therapy (RT) followed by androgen deprivation therapy for 6 months.
• > 15% risk of + LN
Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months.

Locations

Country	Name	City	State
United States	University of Florida Proton Therapy Institute	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

References & Publications (53)

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* Note: There are 53 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Grade 3 or Higher Treatment-related Toxicity Rate.	Number of participants that experienced acute grade 3 or higher, treatment-related toxicity based on CTCAE version 3.0 criteria.	6 months after the completion of radiation therapy
Secondary	Collect and Analyze Quality of Life, Treatment-related Late Morbidity, Disease Control, and Survival Outcome Parameters.		After radiation: every 6 months for 3 years, then annually for 20 years
Secondary	Collect and Analyze Treatment, Biologic and Diagnostic Information That May Impact Quality of Life, Disease Control, Morbidity and/or Survival Outcomes.		After radiation: every 6 months for 3 years, then annually for 20 years