Efficacy as Assessed by 3-year Prostate-specific Antigen Progression-free Survival Rate
| Group | Value (Participants) |
|---|---|
| Chemohormonal and Definitive Therapy After Prostatectomy | 22 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
A Study of Definitive Therapy to Treat Prostate Cancer After Prostatectomy
NCT0304380722 Feb 2017 to 17 Oct 2022
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.
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.
Outcomes the sponsor listed as primary.
Efficacy as Assessed by 3-year Prostate-specific Antigen Progression-free Survival Rate
Time frame · 3 years
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.
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
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
Time to Prostate-specific Antigen Recurrence
Time frame · 3 years
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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Participants) |
|---|---|
| Chemohormonal and Definitive Therapy After Prostatectomy | 22 |
| Group | Value (Participants) |
|---|---|
| Chemohormonal and Definitive Therapy After Prostatectomy | 1 |
| Group | Value (Month) |
|---|---|
| Chemohormonal and Definitive Therapy After Prostatectomy | NA |
| Group | Deaths | Serious events | Other 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 / 26 | 2 / 26 | 26 / 26 |
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