A Phase 1/2 interventional study of Intensity-Modulated Radiation Therapy (IMRT) and Docetaxel+IMRT in Prostate Cancer, sponsored by OHSU Knight Cancer Institute. Terminated at 2 sites in United States. Open to male participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-08-29.
Sponsored by OHSU Knight Cancer Institute · Phase 1/2, Interventional, and Treatment
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.
OBJECTIVES:
Primary
Secondary
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.
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.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.
This study's enrollment of 25 is below the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →OHSU Knight Cancer Institute is the lead sponsor of 243 studies on the registry; 44 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 15 (56%) have results posted.
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Histologically confirmed adenocarcinoma of the prostate
Localized disease, meeting 1 of the following staging criteria:
Meets any of the following high-risk* features:
No evidence of lymph nodes ≥ 2 cm in diameter by pelvic CT scan
PATIENT CHARACTERISTICS:
No active inflammatory bowel disease (IBD) or IBD that is being medically treated
EXCLUSION CRITERIA; PRIOR CONCURRENT THERAPY:
No prior therapy for prostate cancer, including any of the following:
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) · Drug: Docetaxel+IMRT
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 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)
Also known as: Radiation therapy
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)
Also known as: Chemotherapy with Radiation therapy
Maximum Tolerated Dose (MTD)
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
Pathologic Response Rate at the Phase II Dose
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
Prostate-specific Antigen Short-term Response Rate Measured as a Percentage Change in PSA
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)
Long-term Safety
An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure.
Time frame: Regular intervals both study-related and clinical standard of care-related; assessed at end of study treatment. Average timeframe to follow safety was 1 year and includes all grade 3-4 adverse events
Clinical Response to Treatment as Measured by Urologic Examination
Biochemical Recurrence is defined as a detectable or rising PSA value after surgery that is 0.2 ng/mL or greater with a second confirmatory level of 0.2 ng/mL or greater.
Time frame: Each participant was examined 3, 6, 9, 12 months, and annually for an average of 10 years after surgery.
Surgical Margin Status at Time of Prostatectomy (Count of Subjects With Negative Surgical Margins)
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
Efficacy Assessed Using Health-Related Quality of Life by Expanded Prostate Cancer Index Composite and Urinary Symptom Scores by American Urological Association's Measures
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
Clinical Progression-free Rate as Determined by <0.1ng PSA Results
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
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.
| Milestone | Phase I, Radiation Only | Phase I, Dose 1 | Phase I, Dose 2 | Phase I, Dose 3 | Phase II, MTD Dose |
|---|---|---|---|---|---|
| Started | 3 | 3 | 3 | 3 | 0 |
| Completed | 3 | 3 | 3 | 3 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
| Milestone | Phase I, Radiation Only | Phase I, Dose 1 | Phase I, Dose 2 | Phase I, Dose 3 | Phase II, MTD Dose |
|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 13 |
| Completed | 0 | 0 | 0 | 0 | 13 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
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.
| mg/m^2 | Phase I Dose 1-4 |
|---|---|
| Maximum Tolerated Dose (MTD) | 30 |
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.
| participants | Phase II MTD Dose |
|---|---|
| Pathologic Stage pT2c | 7 |
| Pathologic Stage pT3a | 3 |
| Pathologic Stage pT3b | 3 |
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
| percentage change | All Research Participants |
|---|---|
| Prostate-specific Antigen Short-term Response Rate Measured as a Percentage Change in PSA | -49.1 (-60.3 to -36.7) |
An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure.
| grade 3-4 adverse events | Phase I Dose 1-4 | Phase II MTD Dose |
|---|---|---|
| Long-term Safety | 9 | 8 |
Biochemical Recurrence is defined as a detectable or rising PSA value after surgery that is 0.2 ng/mL or greater with a second confirmatory level of 0.2 ng/mL or greater.
| Participants | Phase I, Radiation Only | Phase I, Dose 1 | Phase I, Dose 2 | Phase I, Dose 3 | Phase II, MTD Dose |
|---|---|---|---|---|---|
| Clinical Response to Treatment as Measured by Urologic Examination | 1 | 2 | 0 | 2 | 5 |
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.
| Participants | Phase I Dose 1-4 | Phase II MTD Dose |
|---|---|---|
| Surgical Margin Status at Time of Prostatectomy (Count of Subjects With Negative Surgical Margins) | 9 | 13 |
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.
| units on a scale | All Research Participants |
|---|---|
| AUA Symptom Score | 0.67 (-2.96 to 4.29) |
| EPIC Urinary Incontinence Score | -36.52 (-51.38 to -21.67) |
| EPIC Urinary Obstructive/Irritative Score | 3.41 (-5.55 to 12.37) |
| EPIC Bowel | 1.45 (-6.42 to 9.33) |
| EPIC Hormonal | 0.00 (-6.42 to 6.42) |
| EPIC Sexual | -36.26 (-48.84 to -23.68) |
The estimated percentage of participants who were progression-free at 5 years per analyses of PSA results post-study treatment.
| percentage of participants | All Research Participants |
|---|---|
| Clinical Progression-free Rate as Determined by <0.1ng PSA Results | 62.8 (41.9 to 83.6) |
Collected over Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase I, Radiation Only | — | 0/3 (0%) | 0/3 (0%) |
| Phase I, Dose 1 | — | 3/3 (100%) | 0/3 (0%) |
| Phase I, Dose 2 | — | 3/3 (100%) | 0/3 (0%) |
| Phase I, Dose 3 | — | 3/3 (100%) | 0/3 (0%) |
| Phase II, MTD Dose | — | 8/13 (61.5%) | 0/13 (0%) |
| Event | Phase I, Radiation Only | Phase I, Dose 1 | Phase I, Dose 2 | Phase I, Dose 3 | Phase II, MTD Dose |
|---|---|---|---|---|---|
| HyperglycemiaMetabolism and nutrition disorders | 0/3 | 2/3 | 0/3 | 1/3 | 1/13 |
| LymphapeniaBlood and lymphatic system disorders | 0/3 | 0/3 | 1/3 | 1/3 | 5/13 |
| Difficulty with ADLsGeneral disorders | 0/3 | 0/3 | 1/3 | 0/3 | 0/13 |
| Hemoglobin (L)Blood and lymphatic system disorders | 0/3 | 1/3 | 0/3 | 1/3 | 0/13 |
| PainSurgical and medical procedures | 0/3 | 0/3 | 1/3 | 0/3 | 0/13 |
| HypophosphatemiaMetabolism and nutrition disorders | 0/3 | 0/3 | 0/3 | 0/3 | 2/13 |
| HypokalemiaBlood and lymphatic system disorders | 0/3 | 0/3 | 0/3 | 0/3 | 0/13 |
| HyponatremiaBlood and lymphatic system disorders | 0/3 | 0/3 | 0/3 | 0/3 | 0/13 |
| Age, Categorical(Participants) | Phase I, Radiation Only | Phase I, Dose 1 | Phase I, Dose 2 | Phase I, Dose 3 | Phase II, MTD Dose | Total |
|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 2 | 2 | 3 | 11 | 20 |
| >=65 years | 1 | 1 | 1 | 0 | 2 | 5 |
| Age, Continuous(years) | Phase I, Radiation Only | Phase I, Dose 1 | Phase I, Dose 2 | Phase I, Dose 3 | Phase II, MTD Dose | Total |
|---|---|---|---|---|---|---|
| Mean | 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(Participants) | Phase I, Radiation Only | Phase I, Dose 1 | Phase I, Dose 2 | Phase I, Dose 3 | Phase II, MTD Dose | Total |
|---|---|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 | 0 | 0 |
| Male | 3 | 3 | 3 | 3 | 13 | 25 |
| Region of Enrollment(participants) | Phase I, Radiation Only | Phase I, Dose 1 | Phase I, Dose 2 | Phase I, Dose 3 | Phase II, MTD Dose | Total |
|---|---|---|---|---|---|---|
| United States | 3 | 3 | 3 | 3 | 13 | 25 |
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