Radiation Therapy and Docetaxel in Treating Patients Who Are Undergoing Surgery for Localized Prostate Cancer

• Sponsor: OHSU Knight Cancer Institute (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT00321698
• Collaborator: (none)
• Enrollment: 25
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 203
• Patients Per Site: 12.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. 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. Giving radiation therapy together with chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when given together with radiation therapy and to see how well they work in treating patients who are undergoing surgery for high-risk localized prostate cancer.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Radiation: Intensity-Modulated Radiation Therapy (IMRT); Drug: Docetaxel+IMRT	Phase 1/Phase 2

Detailed Description

OBJECTIVES:

Primary

• Determine the maximum tolerated dose (MTD) of neoadjuvant radiotherapy and docetaxel in patients who are undergoing prostatectomy for high-risk localized prostate cancer.

• Determine the pathologic response rate in patients treated at the phase II dose.

Secondary

• Determine the prostate-specific antigen (PSA) short-term response rate in patients treated with this regimen.

• Determine the long-term safety of this regimen prior to radical prostatectomy in these patients.

• Determine the clinical response to this regimen by urologic examination of these patients.

• Determine the surgical margin status at the time of prostatectomy in patients treated with this regimen.

• Determine the effect of this regimen, in terms of Health-Related Quality of Life by Expanded Prostate Cancer Index Composite (EPIC) and urinary symptom scores by the American Urological Association's measures, in these patients.

• Determine the clinical progression-free rate in patients treated with this regimen.

• Identify pretreatment predictors of response in these patients by examining tissue biomarkers in preserved pretreatment biopsy specimens.

• Determine the biologic impact of this regimen on these patients by examining the prostatectomy specimens.

• Collect frozen serum for future analysis of correlative biomarkers.

• Compare the RNA content (gene expression profile) of pre- and post-treatment tumor specimens in order to describe the molecular impact of this regimen on prostate cancer.

OUTLINE: This is a phase I, dose-escalation study of docetaxel followed by a phase II study. All patients undergo a biopsy of the prostate to gather research-only specimens prior to the beginning of treatment.

• Phase I: Patients undergo radiotherapy once daily, 5 days a week, for 5 weeks. Patients also receive docetaxel IV on days 1, 8, 15, 22, and 29. Treatment continues in the absence of disease progression or unacceptable toxicity. Approximately 4-6 weeks after completion of chemoradiotherapy, patients undergo a radical prostatectomy.

Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience a dose-limiting toxicity. At least 6 patients are treated at the MTD.

• Phase II: Patients undergo radiotherapy as in phase I. Patients also receive docetaxel at the MTD determined in phase I and then undergo prostatectomy as in phase I.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I/II Study of Preoperative Radiation and Docetaxel Activity in High Risk Localized Prostate Cancer
• Actual Study Start Date: Jan 31, 2006
• Actual Primary Completion Date: Oct 1, 2009
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Phase I Dose 1-4 Group 1=radiation only; Group 2=Docetaxel IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=Docetaxel IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)	Radiation: Intensity-Modulated Radiation Therapy (IMRT); Group 1=radiation only; All men in all Arms/Groups receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions); Other Names: Radiation therapy ; Drug: Docetaxel+IMRT; Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation; Phase II with no phase I dose-limiting toxicities=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions); Other Names: Chemotherapy with Radiation therapy
Experimental: Phase II MTD Dose Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)	Drug: Docetaxel+IMRT; Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation; Phase II with no phase I dose-limiting toxicities=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions); Other Names: Chemotherapy with Radiation therapy

Outcome Measures

Primary Outcome Measures

1. Maximum Tolerated Dose (MTD) [5 weeks]

   Maximal tolerated dose (MTD) of the combination radiation (45 Gy) and docetaxel. The dose of radiation will be fixed at 45 Gy while the dose of docetaxel will be escalated. The starting dose of docetaxel will be 10 mg/m2 and will be escalated in increments of 10 mg/m2 up to a dose of 30 mg/m2 the pre-planned ceiling). MTD will be the dose that is associated with no more than 1 dose limiting toxicity (DLT) up to 6 patients. The DLT will be defined as clinically significant grade 3 non-hematologic or grade 4 hematologic toxicity, attributable to the chemoirradiation. If 2 of 3 patients experience a DLT, dose escalation will stop and the previous dose level will be considered the MTD. If 1 of 3 has DLT, additional 3 patients will be enrolled at the same dose level. If none of the additional 3 patients has DLT, the dose escalation will continue. If 1 additional patient has DLT, the previous dose will be considered the MTD and dose escalation will be stopped.

2. Pathologic Response Rate at the Phase II Dose [4-6 weeks after study treatment]

   Pathologic response rate is determined post-prostatectomy by pathologist laboratory analyses. The TNM system is the most widely used cancer staging system. Most hospitals and medical centers use the TNM system as their main method for cancer reporting. In the TNM system: The T refers to the size and extent of the main/primary tumor. T1, T2, T3, T4: Refers to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. T's may be further divided to provide more detail, such as T3a and T3b.

Secondary Outcome Measures

1. Prostate-specific Antigen Short-term Response Rate Measured as a Percentage Change in PSA [Baseline (pre-treatment) and 1 month after surgery (post-treatment)]

   All participants were combined for this assessment as pre-specified in the protocol. The percentage change for patients were determined from pre- and post- treatment PSA values. The mean percentage change in PSA will be reported. PSA will be monitored every 3-6 months during the first 5 years, then annually after surgery for up to 10 years

2. Long-term Safety [Regular intervals (clinical contact)]

3. Clinical Response to Treatment as Measured by Urologic Examination [Regular intervals (clinical contact)]

4. Surgical Margin Status at Time of Prostatectomy (Count of Subjects With Negative Surgical Margins) [5 weeks]

   Pathologic response rate is determined post-prostatectomy by pathologist laboratory analyses. The TNM system is the most widely used cancer staging system. Most hospitals and medical centers use the TNM system as their main method for cancer reporting. In the TNM system: The M refers to whether the cancer has metastasized. This means that the cancer has spread outside of the primary tumor to other parts of the body.

5. Efficacy Assessed Using Health-Related Quality of Life by Expanded Prostate Cancer Index Composite and Urinary Symptom Scores by American Urological Association's Measures [Baseline and 12 Months Post-Prostatectomy]

   Mean change in score from Baseline to 12-months pot-op. A single outcome, Health Related Quality of Life (QOL), was specified in the protocol. All 6 score means and confidence intervals are reported here as a single outcome; a separate row for each score. AUA Symptom Score is designed to measure lower urinary tract symptoms (LUTS) resulting from benign prostatic hyperplasia or other causes in men. Higher scores indicate more LUTS (scale 0-35). 1-7, mild; 8-19, moderate; 20-35, severe. EPIC quality of life instruments is a 32-item self-report questionnaire that measures the QOL of prostate cancer patients. 4 subscales measuring urinary (further consisting of two sub-components, EPIC Urinary Incontinence Score and EPIC Urinary Obstructive/Irritative Score), bowel, sexual and hormonal changes. Scores for each of the subscales, as well as for each sub-component within the Urinary sub scale, are transformed linearly to a 0-100 scale with higher scores representing better QOL.

6. Clinical Progression-free Rate as Determined by <0.1ng PSA Results [3, 6, 9, 12 months and annually, up to 5 years]

   The estimated percentage of participants who were progression-free at 5 years per analyses of PSA results post-study treatment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

INCLUSION CRITERIA; DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate

• Localized disease, meeting 1 of the following staging criteria:

• Clinical stage T2b (palpable bilateral movement) disease

• Surgically resectable T3 disease

• Meets any of the following high-risk* features:

• PSA ≥ 15 ng/mL

• Gleason grade ≥ 4+3 (4+3, 4+4, or 5+any, but not 3+4) NOTE: *High risk defined as

50% chance of failure with local therapy

• Plans to undergo prostatectomy as primary therapy

• No evidence of lymph nodes ≥ 2 cm in diameter by pelvic CT scan

• Scan only required in patients with a PSA ≥ 40 ng/mL

• No evidence of bone metastases by bone scan

PATIENT CHARACTERISTICS:

• Life expectancy ≥ 10 years

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• White blood cell (WBC) > 3,000/mm^3

• Neutrophil count > 1,500/mm^3

• Platelet count > 100,000/mm^3

• Direct bilirubin normal

• Alanine aminotransferase (ALT) < 2.0 times upper limit of normal (ULN) (1.5 times ULN if alkaline phosphatase [AP] > 2.5 times ULN)

• Alkaline phosphatase (AP) < 4.0 times ULN

• No other serious medical condition that would preclude study treatment

• No other malignancy within the past 5 years except nonmelanoma skin cancer

• No peripheral neuropathy ≥ grade 2

• No hypersensitivity to drugs formulated with polysorbate 80

• No significant contraindications to corticosteroids

• No history of scleroderma

• No active inflammatory bowel disease (IBD) or IBD that is being medically treated

• Inclusion of patients with a remote history of IBD is at the discretion of radiotherapist

EXCLUSION CRITERIA; PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior therapy for prostate cancer, including any of the following:

• Conventional hormonal therapy (e.g., orchiectomy, luteinizing hormone-releasing hormone therapy, antiandrogen therapy, or estrogen therapy)

• External-beam radiotherapy or brachytherapy

• Cryotherapy

• Cytotoxic chemotherapy

• No prior pelvic radiotherapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Veterans Affairs Medical Center - Portland	Portland	Oregon	United States	97207
2	OHSU Knight Cancer Institute	Portland	Oregon	United States	97239-3098

Sponsors and Collaborators

• OHSU Knight Cancer Institute

Investigators

• Principal Investigator: Mark Garzotto, MD, OHSU Knight Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mark Garzotto, MD, Principal Investigator, OHSU Knight Cancer Institute
• ClinicalTrials.gov Identifier: NCT00321698
• Other Study ID Numbers: IRB00001581; IIT16179; OHSU-1581; PVAMC-11-1205/ M1675; OHSU-SOL-05077-L; CDR0000467219; NCI-2012-01122
• First Posted: May 4, 2006
• Last Update Posted: May 13, 2022
• Last Verified: Apr 1, 2022

• Keywords provided by Mark Garzotto, MD, Principal Investigator, OHSU Knight Cancer Institute: adenocarcinoma of the prostate; stage II prostate cancer; stage III prostate cancer
• Additional relevant MeSH terms: Prostatic Neoplasms; Docetaxel

Study Results

Participant Flow

Recruitment Details	Subject accrual from Urology clinics started in April 2006; annual follow-up of 22 VA, 3 Oregon Health & Science University (OHSU) (25 total) subjects who completed ended in 2011; 10 year follow-up of these patients will be completed in 2021.
Pre-assignment Detail	Our 1 screen failure was excluded as a result of having a different type of cancer, other than non-melanoma skin cancer, within the past 5 years.

Arm/Group Title	Phase I, Radiation Only	Phase I, Dose 1	Phase I, Dose 2	Phase I, Dose 3	Phase II, MTD Dose
Arm/Group Description	Group 1=radiation only; Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)	Group 2=IV over 30mins, 10mg/m2 weekly x 5 weeks starting on day one of radiation; Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions) Chemotherapy (Groups 2-4): Docetaxel IV over 30mins weekly x 5 weeks starting on day one of radiation. The maximum planned dose of 30 mg/m2 was reached without Dose-Limiting Toxicities.	Group 3=IV over 30mins, 20mg/m2 weekly x 5 weeks starting on day one of radiation; Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions) Chemotherapy (Groups 2-4): Docetaxel IV over 30mins weekly x 5 weeks starting on day one of radiation. The maximum planned dose of 30 mg/m2 was reached without Dose-Limiting Toxicities.	Group 4=IV over 30mins, 30mg/m2 weekly x 5 weeks starting on day one of radiation; Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions) Chemotherapy (Groups 2-4): Docetaxel IV over 30mins weekly x 5 weeks starting on day one of radiation. The maximum planned dose of 30 mg/m2 was reached without Dose-Limiting Toxicities.	MTD=Docetaxel IV over 30mins, 30mg/m2 weekly x 5 weeks starting on day one of radiation plus external beam radiation, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions). Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
Period Title: Phase I, Rad Only & Dose 1-3
STARTED	3	3	3	3	0
COMPLETED	3	3	3	3	0
NOT COMPLETED	0	0	0	0	0
Period Title: Phase I, Rad Only & Dose 1-3
STARTED	0	0	0	0	13
COMPLETED	0	0	0	0	13
NOT COMPLETED	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Phase I, Radiation Only	Phase I, Dose 1	Phase I, Dose 2	Phase I, Dose 3	Phase II, MTD Dose	Total
Arm/Group Description	Drug: N/A 4 groups of men in phase I study. Group 1=radiation only Radiation: radiation therapy All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)	Drug: docetaxel 4 groups of men in phase I study. Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Radiation: radiation therapy All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)	Drug: docetaxel 4 groups of men in phase I study. Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Radiation: radiation therapy All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)	Drug: docetaxel 4 groups of men in phase I study. Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation Radiation: radiation therapy All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)	Drug: docetaxel Phase II with no phase I dose-limiting toxicities=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation Radiation: radiation therapy All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)	Total of all reporting groups
Overall Participants	3	3	3	3	13	25
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	2 66.7%	2 66.7%	2 66.7%	3 100%	11 84.6%	20 80%
>=65 years	1 33.3%	1 33.3%	1 33.3%	0 0%	2 15.4%	5 20%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.67 (8.14)	62.67 (7.64)	66.33 (4.93)	58.00 (6.56)	60.54 (4.58)	61.92 (5.89)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Male	3 100%	3 100%	3 100%	3 100%	13 100%	25 100%
Region of Enrollment (participants) [Number]
United States	3 100%	3 100%	3 100%	3 100%	13 100%	25 100%

Outcome Measures

1. Primary Outcome

Title	Maximum Tolerated Dose (MTD)
Description	Maximal tolerated dose (MTD) of the combination radiation (45 Gy) and docetaxel. The dose of radiation will be fixed at 45 Gy while the dose of docetaxel will be escalated. The starting dose of docetaxel will be 10 mg/m2 and will be escalated in increments of 10 mg/m2 up to a dose of 30 mg/m2 the pre-planned ceiling). MTD will be the dose that is associated with no more than 1 dose limiting toxicity (DLT) up to 6 patients. The DLT will be defined as clinically significant grade 3 non-hematologic or grade 4 hematologic toxicity, attributable to the chemoirradiation. If 2 of 3 patients experience a DLT, dose escalation will stop and the previous dose level will be considered the MTD. If 1 of 3 has DLT, additional 3 patients will be enrolled at the same dose level. If none of the additional 3 patients has DLT, the dose escalation will continue. If 1 additional patient has DLT, the previous dose will be considered the MTD and dose escalation will be stopped.
Time Frame	5 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phase I Dose 1-4
Arm/Group Description	4 groups of men in phase I study. Group 1=radiation only; Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.
Measure Participants	12
Number [mg/m^2]	30

2. Primary Outcome

Title	Pathologic Response Rate at the Phase II Dose
Description	Pathologic response rate is determined post-prostatectomy by pathologist laboratory analyses. The TNM system is the most widely used cancer staging system. Most hospitals and medical centers use the TNM system as their main method for cancer reporting. In the TNM system: The T refers to the size and extent of the main/primary tumor. T1, T2, T3, T4: Refers to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. T's may be further divided to provide more detail, such as T3a and T3b.
Time Frame	4-6 weeks after study treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phase II MTD Dose
Arm/Group Description	Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
Measure Participants	13
Pathologic Stage pT2c	7 233.3%
Pathologic Stage pT3a	3 100%
Pathologic Stage pT3b	3 100%

3. Secondary Outcome

Title	Prostate-specific Antigen Short-term Response Rate Measured as a Percentage Change in PSA
Description	All participants were combined for this assessment as pre-specified in the protocol. The percentage change for patients were determined from pre- and post- treatment PSA values. The mean percentage change in PSA will be reported. PSA will be monitored every 3-6 months during the first 5 years, then annually after surgery for up to 10 years
Time Frame	Baseline (pre-treatment) and 1 month after surgery (post-treatment)

Outcome Measure Data

Analysis Population Description

Pre- and post-treatment PSA values were available in 22 of 25 patients.

Arm/Group Title	All Research Participants
Arm/Group Description	This Outcome Measure was assessed in aggregate, combining participants from both phases of the study, as per the planned protocol. Phase I: Group 1=radiation only; Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation. Phase II: Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation. Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions).
Measure Participants	22
Mean (95% Confidence Interval) [percentage change]	-49.1

4. Secondary Outcome

Title	Long-term Safety
Time Frame	Regular intervals (clinical contact)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Clinical Response to Treatment as Measured by Urologic Examination
Time Frame	Regular intervals (clinical contact)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Surgical Margin Status at Time of Prostatectomy (Count of Subjects With Negative Surgical Margins)
Description	Pathologic response rate is determined post-prostatectomy by pathologist laboratory analyses. The TNM system is the most widely used cancer staging system. Most hospitals and medical centers use the TNM system as their main method for cancer reporting. In the TNM system: The M refers to whether the cancer has metastasized. This means that the cancer has spread outside of the primary tumor to other parts of the body.
Time Frame	5 weeks

Outcome Measure Data

Analysis Population Description

For Phase I Dose 1-4, all participants were combined for this assessment as pre-specified in the protocol.

Arm/Group Title	Phase I Dose 1-4	Phase II MTD Dose
Arm/Group Description	Group 1=radiation only; Group 2=Docetaxel IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=Docetaxel IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)	Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
Measure Participants	12	13
Count of Participants [Participants]	9 300%	13 433.3%

7. Secondary Outcome

Title	Efficacy Assessed Using Health-Related Quality of Life by Expanded Prostate Cancer Index Composite and Urinary Symptom Scores by American Urological Association's Measures
Description	Mean change in score from Baseline to 12-months pot-op. A single outcome, Health Related Quality of Life (QOL), was specified in the protocol. All 6 score means and confidence intervals are reported here as a single outcome; a separate row for each score. AUA Symptom Score is designed to measure lower urinary tract symptoms (LUTS) resulting from benign prostatic hyperplasia or other causes in men. Higher scores indicate more LUTS (scale 0-35). 1-7, mild; 8-19, moderate; 20-35, severe. EPIC quality of life instruments is a 32-item self-report questionnaire that measures the QOL of prostate cancer patients. 4 subscales measuring urinary (further consisting of two sub-components, EPIC Urinary Incontinence Score and EPIC Urinary Obstructive/Irritative Score), bowel, sexual and hormonal changes. Scores for each of the subscales, as well as for each sub-component within the Urinary sub scale, are transformed linearly to a 0-100 scale with higher scores representing better QOL.
Time Frame	Baseline and 12 Months Post-Prostatectomy

Outcome Measure Data

Analysis Population Description

Scores not available for some participants

Arm/Group Title	All Research Participants
Arm/Group Description	This Outcome Measure was assessed in aggregate, combining participants from both phases of the study, as per the planned protocol. Phase I: Group 1=radiation only; Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation. Phase II: Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation. Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions).
Measure Participants	25
AUA Symptom Score	0.67
EPIC Urinary Incontinence Score	-36.52
EPIC Urinary Obstructive/Irritative Score	3.41
EPIC Bowel	1.45
EPIC Hormonal	0.00
EPIC Sexual	-36.26

8. Secondary Outcome

Title	Clinical Progression-free Rate as Determined by <0.1ng PSA Results
Description	The estimated percentage of participants who were progression-free at 5 years per analyses of PSA results post-study treatment.
Time Frame	3, 6, 9, 12 months and annually, up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Research Participants
Arm/Group Description	This Outcome Measure was assessed in aggregate, combining participants from both phases of the study, as per the planned protocol. Phase I: Group 1=radiation only; Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation. Phase II: Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation. Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions).
Measure Participants	25
Number (95% Confidence Interval) [percentage of participants]	62.8 2093.3%

Adverse Events

Time Frame	An average of 133.84 days.
Adverse Event Reporting Description	For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery. Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
Arm/Group Title	Phase I, Radiation Only		Phase I, Dose 1		Phase I, Dose 2		Phase I, Dose 3		Phase II, MTD Dose
Arm/Group Description	Drug: N/A 4 groups of men in phase I study. Group 1=radiation only Radiation: radiation therapy All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)		Drug: docetaxel 4 groups of men in phase I study. Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Radiation: radiation therapy All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)		Drug: docetaxel 4 groups of men in phase I study. Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Radiation: radiation therapy All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)		Drug: docetaxel 4 groups of men in phase I study. Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation Radiation: radiation therapy All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)		Drug: docetaxel Phase II with no phase I dose-limiting toxicities=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation Radiation: radiation therapy All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
All Cause Mortality
	Phase I, Radiation Only		Phase I, Dose 1		Phase I, Dose 2		Phase I, Dose 3		Phase II, MTD Dose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Phase I, Radiation Only		Phase I, Dose 1		Phase I, Dose 2		Phase I, Dose 3		Phase II, MTD Dose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		3/3 (100%)		3/3 (100%)		3/3 (100%)		8/13 (61.5%)
Blood and lymphatic system disorders
Lymphapenia	0/3 (0%)	0	0/3 (0%)	0	1/3 (33.3%)	1	1/3 (33.3%)	2	5/13 (38.5%)	5
Hemoglobin (L)	0/3 (0%)	0	1/3 (33.3%)	1	0/3 (0%)	0	1/3 (33.3%)	1	0/13 (0%)	0
Hypokalemia	0/3 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/13 (0%)	0
Hyponatremia	0/3 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/13 (0%)	0
General disorders
Difficulty with ADLs	0/3 (0%)	0	0/3 (0%)	0	1/3 (33.3%)	2	0/3 (0%)	0	0/13 (0%)	0
Metabolism and nutrition disorders
Hyperglycemia	0/3 (0%)	0	2/3 (66.7%)	2	0/3 (0%)	0	1/3 (33.3%)	2	1/13 (7.7%)	1
Hypophosphatemia	0/3 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	2/13 (15.4%)	4
Surgical and medical procedures
Pain	0/3 (0%)	0	0/3 (0%)	0	1/3 (33.3%)	1	0/3 (0%)	0	0/13 (0%)	0
Other (Not Including Serious) Adverse Events
	Phase I, Radiation Only		Phase I, Dose 1		Phase I, Dose 2		Phase I, Dose 3		Phase II, MTD Dose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/13 (0%)

Limitations/Caveats

Patient accrual was not completed due to the sponsor withdrawing funding.

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.