Trial Outcomes & Findings for A Study of Definitive Therapy to Treat Prostate Cancer (NCT NCT02716974)
NCT ID: NCT02716974
Last Updated: 2022-08-04
Results Overview
To evaluate efficacy of multimodality therapy in men, defined as the 2 year PSA progression-free (PSA\<0.2 ng/ml) survival among men who have non-castrate testosterone levels 2 years after enrollment. Number of participants (who have non-castrate testosterone levels 2 years after enrollment) with PSA progression-free survival.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
2 years
Results posted on
2022-08-04
Participant Flow
Participant milestones
| Measure |
Chemohormonal and Definitive Therapy
(1st) Systemic chemo-hormonal therapy with up to 6-months (\~24 weeks) of neoadjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with prostatectomy +/- adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 1 year of androgen deprivation. Androgen blockade (Bicalutamide) will be the same throughout the course of treatment.
Leuprolide Acetate: 22.5mg by intramuscular (IM) injection every 3 months
Bicalutamide: bicalutamide (Casodex) 50mg by mouth daily
Docetaxel: Docetaxel (taxotere) 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles.
Prostatectomy: Removal of the entire prostate gland, plus some surrounding tissue.
Radiation: 5 high dose radiation treatments to the metastatic (tumor has spread to other parts of the body) sites.
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Definitive Therapy to Treat Prostate Cancer
Baseline characteristics by cohort
| Measure |
Chemohormonal and Definitive Therapy
n=26 Participants
(1st) Systemic chemo-hormonal therapy with up to 6-months (\~24 weeks) of neoadjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with prostatectomy +/- adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 1 year of androgen deprivation. Androgen blockade (Bicalutamide) will be the same throughout the course of treatment.
Leuprolide Acetate: 22.5mg by intramuscular (IM) injection every 3 months
Bicalutamide: bicalutamide (Casodex) 50mg by mouth daily
Docetaxel: Docetaxel (taxotere) 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles.
Prostatectomy: Removal of the entire prostate gland, plus some surrounding tissue.
Radiation: 5 high dose radiation treatments to the metastatic (tumor has spread to other parts of the body) sites.
|
|---|---|
|
Age, Continuous
|
59.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsTo evaluate efficacy of multimodality therapy in men, defined as the 2 year PSA progression-free (PSA\<0.2 ng/ml) survival among men who have non-castrate testosterone levels 2 years after enrollment. Number of participants (who have non-castrate testosterone levels 2 years after enrollment) with PSA progression-free survival.
Outcome measures
| Measure |
Chemohormonal and Definitive Therapy
n=26 Participants
(1st) Systemic chemo-hormonal therapy with up to 6-months (\~24 weeks) of neoadjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with prostatectomy +/- adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 1 year of androgen deprivation. Androgen blockade (Bicalutamide) will be the same throughout the course of treatment.
Leuprolide Acetate: 22.5mg by intramuscular (IM) injection every 3 months
Bicalutamide: bicalutamide (Casodex) 50mg by mouth daily
Docetaxel: Docetaxel (taxotere) 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles.
Prostatectomy: Removal of the entire prostate gland, plus some surrounding tissue.
Radiation: 5 high dose radiation treatments to the metastatic (tumor has spread to other parts of the body) sites.
|
|---|---|
|
Efficacy as Assessed by 2-year PSA Progression-free Survival Rate
|
17 Participants
|
SECONDARY outcome
Timeframe: 3 yearsTo assess the safety and therapeutic benefit of multimodality therapy in men presenting with newly diagnosed oligometastatic prostate cancer (\<5 sites of metastases). Safety is defined as the incidence of Grades 3 and 4 neutropenia and surgical- or radiation-induced toxicities. Neutropenia is a lower than normal number of neutrophils (a type of white blood cell) in the blood. Although dependent on the specific laboratory, the normal number is of neutrophils is generally about 1500-7800 cells/microliter. Grade 3 and 4 neutropenia refer to neutrophil levels \<1,000-500 and \<500, respectively. The average risk of docetaxel-induced Grade 3 and 4 neutropenia is about 35%. During the course of the study, if we had seen evidence that the risk of Grade 3 and 4 neutropenia was \>50%, the study would have been stopped.
Outcome measures
| Measure |
Chemohormonal and Definitive Therapy
n=26 Participants
(1st) Systemic chemo-hormonal therapy with up to 6-months (\~24 weeks) of neoadjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with prostatectomy +/- adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 1 year of androgen deprivation. Androgen blockade (Bicalutamide) will be the same throughout the course of treatment.
Leuprolide Acetate: 22.5mg by intramuscular (IM) injection every 3 months
Bicalutamide: bicalutamide (Casodex) 50mg by mouth daily
Docetaxel: Docetaxel (taxotere) 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles.
Prostatectomy: Removal of the entire prostate gland, plus some surrounding tissue.
Radiation: 5 high dose radiation treatments to the metastatic (tumor has spread to other parts of the body) sites.
|
|---|---|
|
Safety of the Multimodality Therapy as Assessed by Number of Participants With Neutropenia and Surgical or Radiation Toxicities
|
26 Participants
|
SECONDARY outcome
Timeframe: 3 yearsTo investigate the time from an undetectable prostate-specific antigen (≤0.2 ng/mL) until the prostate-specific antigen is \>0.2 over two time-points.
Outcome measures
| Measure |
Chemohormonal and Definitive Therapy
n=26 Participants
(1st) Systemic chemo-hormonal therapy with up to 6-months (\~24 weeks) of neoadjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with prostatectomy +/- adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 1 year of androgen deprivation. Androgen blockade (Bicalutamide) will be the same throughout the course of treatment.
Leuprolide Acetate: 22.5mg by intramuscular (IM) injection every 3 months
Bicalutamide: bicalutamide (Casodex) 50mg by mouth daily
Docetaxel: Docetaxel (taxotere) 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles.
Prostatectomy: Removal of the entire prostate gland, plus some surrounding tissue.
Radiation: 5 high dose radiation treatments to the metastatic (tumor has spread to other parts of the body) sites.
|
|---|---|
|
Time to Prostate-specific Antigen Recurrence
|
31 Months
Interval 25.2 to 32.3
|
Adverse Events
Chemohormonal and Definitive Therapy
Serious events: 2 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chemohormonal and Definitive Therapy
n=26 participants at risk
(1st) Systemic chemo-hormonal therapy with up to 6-months (\~24 weeks) of neoadjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with prostatectomy +/- adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 1 year of androgen deprivation. Androgen blockade (Bicalutamide) will be the same throughout the course of treatment.
Leuprolide Acetate: 22.5mg by intramuscular (IM) injection every 3 months
Bicalutamide: bicalutamide (Casodex) 50mg by mouth daily
Docetaxel: Docetaxel (taxotere) 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles.
Prostatectomy: Removal of the entire prostate gland, plus some surrounding tissue.
Radiation: 5 high dose radiation treatments to the metastatic (tumor has spread to other parts of the body) sites.
|
|---|---|
|
Injury, poisoning and procedural complications
back pain
|
3.8%
1/26 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
abdominal pain
|
3.8%
1/26 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
partial bowel obstruction
|
3.8%
1/26 • Number of events 1 • Up to 2 years
|
|
Blood and lymphatic system disorders
neutropenic fever
|
3.8%
1/26 • Number of events 1 • Up to 2 years
|
Other adverse events
| Measure |
Chemohormonal and Definitive Therapy
n=26 participants at risk
(1st) Systemic chemo-hormonal therapy with up to 6-months (\~24 weeks) of neoadjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with prostatectomy +/- adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 1 year of androgen deprivation. Androgen blockade (Bicalutamide) will be the same throughout the course of treatment.
Leuprolide Acetate: 22.5mg by intramuscular (IM) injection every 3 months
Bicalutamide: bicalutamide (Casodex) 50mg by mouth daily
Docetaxel: Docetaxel (taxotere) 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles.
Prostatectomy: Removal of the entire prostate gland, plus some surrounding tissue.
Radiation: 5 high dose radiation treatments to the metastatic (tumor has spread to other parts of the body) sites.
|
|---|---|
|
General disorders
edema
|
19.2%
5/26 • Number of events 6 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
alopecia
|
11.5%
3/26 • Number of events 3 • Up to 2 years
|
|
Gastrointestinal disorders
constipation
|
7.7%
2/26 • Number of events 2 • Up to 2 years
|
|
Renal and urinary disorders
urinary incontinence
|
11.5%
3/26 • Number of events 4 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
bone pain
|
7.7%
2/26 • Number of events 2 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
back pain
|
7.7%
2/26 • Number of events 2 • Up to 2 years
|
|
Gastrointestinal disorders
abdominal pain
|
7.7%
2/26 • Number of events 2 • Up to 2 years
|
|
Nervous system disorders
nerve pain
|
3.8%
1/26 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
diarrhea
|
7.7%
2/26 • Number of events 2 • Up to 2 years
|
|
General disorders
fatigue
|
57.7%
15/26 • Number of events 15 • Up to 2 years
|
|
Vascular disorders
hot flashes
|
42.3%
11/26 • Number of events 11 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
11.5%
3/26 • Number of events 3 • Up to 2 years
|
|
Nervous system disorders
headache
|
7.7%
2/26 • Number of events 2 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
muscle aches
|
3.8%
1/26 • Number of events 1 • Up to 2 years
|
|
Renal and urinary disorders
hematuria
|
7.7%
2/26 • Number of events 2 • Up to 2 years
|
|
Nervous system disorders
dysgeusia
|
7.7%
2/26 • Number of events 2 • Up to 2 years
|
|
Gastrointestinal disorders
nausea
|
15.4%
4/26 • Number of events 5 • Up to 2 years
|
|
Nervous system disorders
neuropathy
|
23.1%
6/26 • Number of events 7 • Up to 2 years
|
|
Blood and lymphatic system disorders
anemia
|
3.8%
1/26 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
hoarseness
|
7.7%
2/26 • Number of events 2 • Up to 2 years
|
|
Blood and lymphatic system disorders
white blood cell decreased
|
11.5%
3/26 • Number of events 4 • Up to 2 years
|
|
Eye disorders
blurred vision
|
3.8%
1/26 • Number of events 1 • Up to 2 years
|
|
Psychiatric disorders
insomnia
|
11.5%
3/26 • Number of events 3 • Up to 2 years
|
|
Investigations
alkaline phosphatase increased
|
3.8%
1/26 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
xerostomia
|
7.7%
2/26 • Number of events 3 • Up to 2 years
|
|
Infections and infestations
pruritus
|
3.8%
1/26 • Number of events 1 • Up to 2 years
|
|
Ear and labyrinth disorders
tinnitus
|
3.8%
1/26 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
hiccups
|
11.5%
3/26 • Number of events 3 • Up to 2 years
|
|
Investigations
weight gain
|
3.8%
1/26 • Number of events 1 • Up to 2 years
|
|
Vascular disorders
hypertension
|
3.8%
1/26 • Number of events 3 • Up to 2 years
|
|
Hepatobiliary disorders
bilirubin increased
|
3.8%
1/26 • Number of events 1 • Up to 2 years
|
|
Investigations
(Serum Glutamic-Oxaloacetic Transaminase)SGOT increased
|
3.8%
1/26 • Number of events 2 • Up to 2 years
|
|
Investigations
(Serum Glutamic-Pyruvic Transaminase) SGPT increased
|
3.8%
1/26 • Number of events 1 • Up to 2 years
|
|
General disorders
infusion reaction
|
3.8%
1/26 • Number of events 2 • Up to 2 years
|
|
Eye disorders
floater eyes
|
3.8%
1/26 • Number of events 1 • Up to 2 years
|
|
Psychiatric disorders
decreased libido
|
3.8%
1/26 • Number of events 1 • Up to 2 years
|
|
Blood and lymphatic system disorders
neutrophil count decreased
|
3.8%
1/26 • Number of events 2 • Up to 2 years
|
|
Blood and lymphatic system disorders
lymphocyte count decreased
|
3.8%
1/26 • Number of events 1 • Up to 2 years
|
|
Metabolism and nutrition disorders
hyperglycemia
|
11.5%
3/26 • Number of events 4 • Up to 2 years
|
|
Psychiatric disorders
stress incontinence
|
7.7%
2/26 • Number of events 2 • Up to 2 years
|
|
Nervous system disorders
intermittent dizziness
|
3.8%
1/26 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
metallic taste
|
3.8%
1/26 • Number of events 1 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
flushed face
|
3.8%
1/26 • Number of events 1 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
right arm rash
|
3.8%
1/26 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
(GERD)gastroesophageal reflux disease
|
3.8%
1/26 • Number of events 1 • Up to 2 years
|
Additional Information
Kenneth Pienta
Johns Hopkins University School of Medicine
Phone: 410-502-3137
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place