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Chemotherapy

Radiation for Prostate Cancer (oligo-mets Trial)

Phase 2
Waitlist Available
Led By Kenneth Pienta, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern cooperative group (ECOG) performance status ≤2
Documented histologically confirmed adenocarcinoma of the prostate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

oligo-mets Trial Summary

This study is evaluating whether a treatment for prostate cancer is safe.

Eligible Conditions
  • Prostate Cancer

oligo-mets Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

oligo-mets Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy as Assessed by 2-year PSA Progression-free Survival Rate
Secondary outcome measures
Safety of the Multimodality Therapy as Assessed by Number of Participants With Neutropenia and Surgical or Radiation Toxicities
Time to Prostate-specific Antigen Recurrence

Side effects data

From 2008 Phase 3 trial • 243 Patients • NCT00216125
60%
NEUTROPHILS/GRANULOCYTES (ANC/AGC)
54%
LEUKOCYTES (TOTAL WBC)
51%
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
48%
DYSPNEA (SHORTNESS OF BREATH)
43%
ESOPHAGITIS
38%
NAUSEA
36%
HEMOGLOBIN
35%
HAIR LOSS/ALOPECIA (SCALP OR BODY)
35%
COUGH
33%
PAIN
32%
ANOREXIA
31%
PAIN - OTHER (SPECIFY, __)
29%
PLATELETS
26%
VOMITING
26%
CONSTIPATION
24%
DIARRHEA
19%
MOOD ALTERATION
18%
NEUROPATHY: SENSORY
18%
INFECTION - OTHER (SPECIFY, __)
18%
WEIGHT LOSS
17%
DIZZINESS
15%
FEBRILE NEUTROPENIA (ANC <1.0 X 10E9/L, FEVER >=38.5 DEGREES C)
15%
PNEUMONITIS/PULMONARY INFILTRATES
15%
HEARTBURN/DYSPEPSIA
13%
INSOMNIA
13%
INFECTION - OTHER
12%
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
12%
GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
11%
DEHYDRATION
11%
GASTROINTESTINAL - OTHER (SPECIFY, __)
11%
HYPOTENSION
10%
LYMPHOPENIA
10%
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY
10%
RASH/DESQUAMATION
10%
RASH: DERMATITIS ASSOCIATED WITH RADIATION
8%
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC)
8%
CARDIAC GENERAL - OTHER (SPECIFY, __)
8%
ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
7%
ALKALINE PHOSPHATASE
7%
PULMONARY/UPPER RESPIRATORY - OTHER (SPECIFY, __)
7%
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY)
7%
SWEATING (DIAPHORESIS)
7%
SODIUM, SERUM-LOW (HYPONATREMIA)
7%
VOICE CHANGES/DYSARTHRIA (E.G., HOARSENESS, LOSS OR ALTERATION IN VOICE, LARYNGITIS)
6%
POTASSIUM, SERUM-LOW (HYPOKALEMIA)
6%
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA
6%
CALCIUM, SERUM-LOW (HYPOCALCEMIA)
6%
AUDITORY/EAR - OTHER (SPECIFY, __)
6%
SYNCOPE (FAINTING)
6%
METABOLIC/LABORATORY - OTHER (SPECIFY, __)
5%
CHOLESTEROL, SERUM-HIGH (HYPERCHOLESTREMIA)
5%
HICCOUGHS (HICCUPS, SINGULTUS)
5%
CREATININE
5%
PLEURAL EFFUSION (NON-MALIGNANT)
4%
CONSTITUTIONAL SYMPTOMS - OTHER (SPECIFY, __)
4%
HYPERTENSION
4%
MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)
4%
BLOOD/BONE MARROW - OTHER (SPECIFY, __)
4%
POTASSIUM, SERUM-HIGH (HYPERKALEMIA)
4%
THROMBOSIS/THROMBUS/EMBOLISM
4%
HEMOLYSIS (E.G., IMMUNE HEMOLYTIC ANEMIA, DRUG-RELATED HEMOLYSIS)
4%
RIGORS/CHILLS
4%
DERMATOLOGY/SKIN - OTHER (SPECIFY, __)
4%
MUCOSITIS/STOMATITIS (CLINICAL EXAM)
4%
NEUROPATHY: MOTOR
2%
COAGULATION - OTHER (SPECIFY, __)
2%
HYPOXIA
2%
URINARY RETENTION (INCLUDING NEUROGENIC BLADDER)
2%
HEMORRHAGE/BLEEDING - OTHER
2%
EXTRAPYRAMIDAL/INVOLUNTARY MOVEMENT/RESTLESSNESS
2%
HEMORRHAGE/BLEEDING - OTHER (SPECIFY, __)
2%
PERICARDIAL EFFUSION (NON-MALIGNANT)
2%
BICARBONATE, SERUM-LOW
2%
RASH: ERYTHEMA MULTIFORME (E.G., STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS)
2%
ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)
2%
ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)
2%
MEMORY IMPAIRMENT
1%
OCULAR/VISUAL - OTHER (SPECIFY, __)
1%
HOT FLASHES/FLUSHES
1%
CARDIAC ARRHYTHMIA - OTHER (SPECIFY, __)
1%
COLITIS
1%
GASTRITIS (INCLUDING BILE REFLUX GASTRITIS)
1%
URINARY FREQUENCY/URGENCY
1%
RENAL/GENITOURINARY - OTHER
1%
CARDIAC ARRHYTHMIA - OTHER
1%
CONSTITUTIONAL SYMPTOMS - OTHER
1%
DYSPHAGIA (DIFFICULTY SWALLOWING)
1%
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
1%
BLOOD/BONE MARROW - OTHER
1%
URIC ACID, SERUM-HIGH (HYPERURICEMIA)
1%
INR (INTERNATIONAL NORMALIZED RATIO OF PROTHROMBIN TIME)
1%
VENTRICULAR ARRHYTHMIA
1%
LYMPHATICS - OTHER (SPECIFY, __)
1%
FISTULA, GI
1%
PRURITUS/ITCHING
1%
WATERY EYE (EPIPHORA, TEARING)
1%
SODIUM, SERUM-HIGH (HYPERNATREMIA)
1%
SEIZURE
1%
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
1%
CALCIUM, SERUM-HIGH (HYPERCALCEMIA)
1%
HEMORRHAGE, GI
1%
MUSCULOSKELETAL/SOFT TISSUE - OTHER (SPECIFY, __)
1%
PHOTOSENSITIVITY
1%
PULMONARY FIBROSIS (RADIOGRAPHIC CHANGES)
1%
WEIGHT GAIN
1%
PAIN - OTHER
1%
HEARING: PATIENTS WITHOUT BASELINE AUDIOGRAM AND NOT ENROLLED IN A MONITORING PROGRAM
1%
PULMONARY/UPPER RESPIRATORY - OTHER
1%
ALKALOSIS (METABOLIC OR RESPIRATORY)
1%
CUSHINGOID APPEARANCE (E.G., MOON FACE, BUFFALO HUMP, CENTRIPETAL OBESITY, CUTANEOUS STRIAE)
1%
SYNDROMES - OTHER (SPECIFY, __)
1%
ARTHRITIS (NON-SEPTIC)
1%
BILIRUBIN (HYPERBILIRUBINEMIA)
1%
DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
1%
INFECTION WITH UNKNOWN ANC
1%
INJECTION SITE REACTION/EXTRAVASATION CHANGES
1%
GASTROINTESTINAL - OTHER
1%
GLUCOSE, SERUM-LOW (HYPOGLYCEMIA)
1%
HYPOPIGMENTATION
1%
NAIL CHANGES
100%
80%
60%
40%
20%
0%
Study treatment Arm
Consolidation Docetaxel
Observation Only
Pre-Randomization

oligo-mets Trial Design

1Treatment groups
Experimental Treatment
Group I: chemohormonal and definitive therapyExperimental Treatment5 Interventions
(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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leuprolide
FDA approved
Bicalutamide
FDA approved
Docetaxel
FDA approved
Prostatectomy
2014
Completed Phase 2
~1220
Radiation
2003
Completed Phase 3
~1020

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
556 Previous Clinical Trials
32,837 Total Patients Enrolled
56 Trials studying Prostate Cancer
3,322 Patients Enrolled for Prostate Cancer
Kenneth Pienta, MDPrincipal InvestigatorSKCCC at Johns Hopkins University
5 Previous Clinical Trials
121 Total Patients Enrolled
3 Trials studying Prostate Cancer
36 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of Definitive Therapy to Treat Prostate Cancer
2016. "A Study of Definitive Therapy to Treat Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02716974.
~3 spots leftby Apr 2025
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