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Trial · Interventional

CompletedPhase 2Results postedRegistry data

A Study of Definitive Therapy to Treat Prostate Cancer After Prostatectomy

NCTNCT03043807 (opens ClinicalTrials.gov in a new tab)Other idJ16151Other idIRB00120414

Overview

Status
Completed
Phase
Phase 2
Enrollment
26 participants (actual)
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
22 Feb 2017
Primary completion
17 Oct 2022
Completion
17 Oct 2022
First posted
6 Feb 2017 (estimated)
Last update posted
16 Feb 2023
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2017201820192020202120222023
  1. Ph 2

    A Study of Definitive Therapy to Treat Prostate Cancer After Prostatectomy

    NCT03043807

    22 Feb 2017 to 17 Oct 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

To assess the safety of treating men with oligometastatic prostate cancer with the following therapy: (1st) Systemic chemo-hormonal therapy with up to 6-months (\~24 weeks) of adjuvant androgen deprivation and up to 6 cycles of chemotherapy, (2nd) definitive local tumor control with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 2 years of androgen deprivation. Androgen blockade will be the same throughout the course of treatment.

Interventions

  • Leuprolide AcetateDrug
  • DocetaxelDrug
  • BicalutamideDrug
  • RadiationRadiation
  • Abiraterone AcetateDrug

Arms1

  • Experimental

    chemohormonal and definitive therapy after prostatectomy

    (1st) Systemic chemo-hormonal therapy with up to 6-months (\~24 weeks) of adjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 2 years of androgen deprivation. Androgen blockade (Bicalutamide) will be the same throughout the course of treatment.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Efficacy as Assessed by 3-year Prostate-specific Antigen Progression-free Survival Rate

    Time frame · 3 years

    Registry description

    To evaluate efficacy of multimodality therapy in men, defined as the 3 year Prostate-specific antigen progression-free (Prostate-specific antigen\<0.2 ng/ml) survival rate among men who have non-castrate testosterone levels 2 years after enrollment.

Secondary outcomes(2)
  1. Safety of the 3 Years Multimodality Therapy Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 4 Criteria and the Clavien-Dindo Classification

    Time frame · 3 years

    Registry description

    To assess the safety of multimodality therapy in men presenting with newly diagnosed oligometastatic prostate cancer after prostatectomy. Toxicities related to neoadjuvant therapy, radiation therapy, or stereotactic body radiation therapy (SBRT) will be assessed using CTCAE version 4 criteria. Surgical toxicities will be assessed using the Clavien-Dindo Classification

  2. Time to Prostate-specific Antigen Recurrence

    Time frame · 3 years

    Registry description

    To 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· 3 years

Efficacy as Assessed by 3-year Prostate-specific Antigen Progression-free Survival Rate

GroupValue (Participants)
Chemohormonal and Definitive Therapy After Prostatectomy22
Secondary and other outcome results(2)
Secondary outcomeCount of participants· 3 years

Safety of the 3 Years Multimodality Therapy Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 4 Criteria and the Clavien-Dindo Classification

GroupValue (Participants)
Chemohormonal and Definitive Therapy After Prostatectomy1
Secondary outcomeMedian· 3 years

Time to Prostate-specific Antigen Recurrence

GroupValue (Month)
Chemohormonal and Definitive Therapy After ProstatectomyNA

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Chemohormonal and Definitive Therapy After Prostatectomy(1st) Systemic chemo-hormonal therapy with up to 6-months (\~24 weeks) of adjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 2 years 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 Docetaxel: 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles. Dose may decreased in the following intervals: 65 mg/M2, 55 mg/M2, 35 mg/M2. Bicalutamide: bicalutamide (Casodex) 50mg by mouth daily Radiation: Radiation will be delivered in 1 to 5 fractions, and the dose and fractionation schedule will depend on the size and location of the lesion and the surrounding normal tissue constraints in accordance with AAPM Task Group 101 recommendations. Typical doses include 16 - 24 Gy in 1 fraction, 48 - 50 Gy in 4 fractions, and 50 - 60 Gy in 5 fractions. Abiraterone Acetate: Abiraterone acetate 1000 mg / day may be given at the investigator's discretion.0 / 262 / 2626 / 26

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Willing and able to provide written informed consent. 2. Age ≥ 18 years 3. Eastern cooperative oncology group (ECOG) performance status ≤2 4. Documented histologically confirmed adenocarcinoma of the prostate 5. Willing to undergo the following therapy: (1st) Systemic chemo-hormonal therapy with up to 6-months (\~24 weeks) of neoadjuvant androgen deprivation and up to 6 cycles of chemotherapy, (2nd) definitive local tumor control with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. Additionally, must be willing to be treated with a full two years of androgen deprivation. 6. Oligometastatic prostate cancer: Stage T1-4, N0-1 and/or M1a-b (up to 5 metastatic lesions- including bone lesions and non-regional lymph nodes seen on bone scan, contrast enhanced CT scan, or positron emission tomography PET scan) Exclusion Criteria: 1. Prior local non-surgical therapy to treat prostate cancer (e.g. radiation therapy, brachytherapy) 2. Prior therapy to a metastatic site. 3. Prior or ongoing systemic therapy for prostate cancer including, but not limited to: 1. Hormonal therapy (e.g. leuprolide, goserelin, triptorelin, degarelix) 2. CYP-17 (cytochrome P450 17α-hydroxy/17,20-lyase) inhibitors (e.g. ketoconazole) 3. Antiandrogens (e.g. bicalutamide, nilutamide) 4. Second generation antiandrogens (e.g. enzalutamide, abiraterone) 5. Immunotherapy (e.g. sipuleucel-T, ipilimumab) 6. Chemotherapy (e.g. docetaxel, cabazitaxel) \*Note: may be enrolled if hormone therapy was recently initiated (\<90 days duration)). In the event that hormone therapy was initiated prior to study enrollment, the clock for 2 years of androgen deprivation would begin at the time of therapy initiation, rather than at study enrollment. 4. Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study. 5. Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule. 6. Abnormal bone marrow function \[absolute neutrophil count (ANC)\<1500/mm3, platelet count \<100,000/mm3, hemoglobin \<9 g/dL\] 7. Abnormal liver function (bilirubin \>ULN ( upper limit of normal); AST (aspartate aminotransferase), ALT (alanine transaminase) \> 2.5 x upper limit of normal) 8. Creatinine clearance of ≥ 30 mL/min. CrCl (Creatinine clearance) should be calculated suing the Cockcroft-Gault formula. 9. Active cardiac disease defined as active angina, symptomatic congestive heart failure, or myocardial infarction within previous six months. 10. Prior history of malignancy in the past 3 years with the exception of basal cell and squamous cell carcinoma of the skin. Other malignancies that are considered to have a low potential to progress may be enrolled at discretion of PI.

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