Description:
This phase I/II trial studies the side effects and how well high-dose brachytherapy works in
treating patients with prostate cancer that has not spread to other parts of the body.
Brachytherapy is a type of radiation therapy in which radioactive material sealed in needles,
seeds, wires, or catheters is placed directly into or near a tumor and may be a better
treatment in patients with prostate cancer.
Title
- Brief Title: High-Dose Brachytherapy in Treating Patients With Prostate Cancer
- Official Title: A Phase I/II Study of High-Dose-Rate Brachytherapy as Monotherapy for Prostate Cancer
Clinical Trial IDs
- ORG STUDY ID:
IRB-32058
- SECONDARY ID:
NCI-2015-00089
- SECONDARY ID:
PROS0065
- NCT ID:
NCT02346253
Conditions
- Prostate Adenocarcinoma
- Stage I Prostate Cancer
- Stage IIA Prostate Cancer
- Stage IIB Prostate Cancer
- Stage III Prostate Cancer
Interventions
Drug | Synonyms | Arms |
---|
Bicalutamide | CDX | Treatment (HDR brachytherapy, ADT and LHRH agonist therapy) |
Leuprolide Acetate | A-43818 | Treatment (HDR brachytherapy, ADT and LHRH agonist therapy) |
Goserelin Acetate | ICI-118630, ZDX, Zoladex | Treatment (HDR brachytherapy, ADT and LHRH agonist therapy) |
Triptorelin Pamoate | Pamorelin, Trelstar | Treatment (HDR brachytherapy, ADT and LHRH agonist therapy) |
Degarelix | FE200486, Firmagon | Treatment (HDR brachytherapy, ADT and LHRH agonist therapy) |
Purpose
This phase I/II trial studies the side effects and how well high-dose brachytherapy works in
treating patients with prostate cancer that has not spread to other parts of the body.
Brachytherapy is a type of radiation therapy in which radioactive material sealed in needles,
seeds, wires, or catheters is placed directly into or near a tumor and may be a better
treatment in patients with prostate cancer.
Detailed Description
PRIMARY OBJECTIVES:
I. To estimate the rate of acute (within six months of high-dose rate [HDR] completion) grade
>= 2 genitourinary (GU) toxicity following high-dose-rate (HDR) brachytherapy (BT) as
monotherapy for newly diagnosed prostate cancer using the National Cancer Institute's Common
Terminology Criteria for Adverse Events, version 3 (CTCAE v3.0).
SECONDARY OBJECTIVES:
I. To estimate the proportion of men with a prostate-specific antigen (PSA) nadir by one year
(nPSA12) of < 2 ng/mL.
II. To estimate the rate of freedom from biochemical failure at 5 years (FFBF). III. To
evaluate patient-reported quality of life via the 32-item Expanded Prostate Cancer Index
Composite (EPIC).
IV. To assess the cost-effectiveness of HDR BT as monotherapy for prostate cancer using the
6-item European Quality of Life 5-Dimensions (EQ-5D).
V. To explore pre-treatment clinical risk factors to optimize patient selection for HDR BT as
monotherapy for prostate cancer.
VI. To compare acute and late (> 6 months after HDR completion) GU and gastrointestinal (GI)
grade >= 2 toxicity using CTCAE v3.0 and v4.0.
VII. To explore dosimetric predictors of toxicity.
OUTLINE:
Patients undergo high-dose-rate brachytherapy over 2 fractions. Patients may receive androgen
deprivation therapy (ADT) comprising bicalutamide orally (PO) once daily (QD). Patients may
also receive luteinizing hormone-releasing hormone (LHRH) agonist therapy comprising
leuprolide acetate intramuscularly (IM) or subcutaneously (SC), goserelin acetate SC,
triptorelin pamoate IM, or degarelix SC for 4-6 months (intermediate-risk patients receiving
ADT) or 6-36 months (high-risk patients) at the discretion of the treating physician.
After completion of study treatment, patients are followed up at 3, 6, 9, and 12 months, and
then yearly for up to 5 years.
Trial Arms
Name | Type | Description | Interventions |
---|
Treatment (HDR brachytherapy, ADT and LHRH agonist therapy) | Experimental | Patients undergo high-dose-rate brachytherapy over 2 fractions. Patients also receive ADT comprising bicalutamide PO QD. Patients may also receive LHRH agonist therapy comprising leuprolide acetate IM or SC, goserelin acetate SC, triptorelin pamoate IM, or degarelix SC for 4-6 months (intermediate-risk patients receiving ADT) or 6-36 months (high-risk patients) at the discretion of the treating physician. | - Bicalutamide
- Leuprolide Acetate
- Goserelin Acetate
- Triptorelin Pamoate
- Degarelix
|
Eligibility Criteria
Inclusion Criteria:
- Documented pathologic confirmation of prostate adenocarcinoma
- Clinical T-classification T1-3
- PSA < 150 ng/mL
- Gleason score 6-10
- Clinically negative lymph nodes as established by abdomino-pelvic CT. CT only for
clinical classification of T3 (with contrast if renal function is acceptable; a
non-contrast CT is permitted if the patient is not a candidate for contrast), magnetic
resonance imaging (MRI), nodal sampling, or dissection. Patients with lymph nodes
equivocal or questionable by imaging are eligible if those nodes are <1 cm in short
axis diameter. [56]
- No evidence of bone metastases (M0) on bone scan, only for PSA >20 ng/mLor Gleason ≥8,
(NaF PET/CT is an acceptable substitute). Equivocal bone scan findings are allowed if
plain films and/or MRI are negative for definite metastases.
- American Urological Association Symptom Index (AUA SI) =< 20
Exclusion Criteria:
- Clinical T4 disease
- PSA >= 150 ng/mL
- AUA SI > 20
- History of radical prostatectomy, external beam radiotherapy (EBRT), or BT for
prostate cancer
- Previous chemotherapy for any malignancy, if given within three years of registration
- History of rectal surgery
- History of rectal fistula
- History of inflammatory bowel disease
- Severe, active co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within
the last six months
- Transmural myocardial infarction within the last six months
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | N/A |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Proportion of patients with acute grade 2 or greater acute GU toxicity, scored according to CTCAE v3.0 |
Time Frame: | Within 6 months of HDR completion |
Safety Issue: | |
Description: | Will be calculated with a 90% confidence interval. Treatment plans will be reviewed, and doses to normal structures will be calculated and tabulated to determine possible relationships with toxicity outcomes. |
Secondary Outcome Measures
Measure: | Proportion of men with a nPSA12 of < 2 ng/mL |
Time Frame: | Up to 1 year after completion of HDR |
Safety Issue: | |
Description: | nPSA12 is defined as the lowest PSA level achieved during the first year after completing HDR. |
Measure: | FFBF (Biochemical failure define according to PSA nadir+2ng/mL and 3 consecutive rises definition according to American Society of Radiation Oncology |
Time Frame: | From the completion of all treatment to the time of BF, assessed at 5 years |
Safety Issue: | |
Description: | Biochemical failure (BF) will be defined according the PSA nadir + 2 ng/mL and three consecutive rises definition according to the American Society of Radiation Oncology consensus recommendation. Time to first BF will be analyzed with competing risk models with death as a competing risk. |
Measure: | Change in quality of life as measured by EPIC scores |
Time Frame: | Baseline to up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Cost-effectiveness of HDR BT as monotherapy for prostate cancer using as measured by EQ-5D scores |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | Measured utility values for each patient on this study will be combined with overall survival to calculate the "QALY" quality-adjusted life years. |
Measure: | Pre-treatment clinical risk factors to optimize patient selection for HDR BT as monotherapy for prostate cancer (association between each risk factor and the risk of having a first BF) |
Time Frame: | Baseline |
Safety Issue: | |
Description: | Clinical risk factors will be tested in competing risk models to evaluate the association between each risk factor and the risk of having a first BF. |
Measure: | Proportion of patients with acute grade 2 or greater acute GU toxicity, scored according to CTCAE v4.0 |
Time Frame: | Within 6 months of HDR completion |
Safety Issue: | |
Description: | Will be calculated with a 90% confidence interval. Treatment plans will be reviewed, and doses to normal structures will be calculated and tabulated to determine possible relationships with toxicity outcomes. |
Measure: | Late GU toxicity, scored according to CTCAE v3.0 and v4.0 |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | Will be calculated with a 90% confidence interval. Treatment plans will be reviewed, and doses to normal structures will be calculated and tabulated to determine possible relationships with toxicity outcomes. |
Measure: | Acute GI toxicity scored according to CTCAE v3.0 and CTCAE v4.0 |
Time Frame: | Up to 6 months after completing HDR BT |
Safety Issue: | |
Description: | Will be calculated with a 90% confidence interval. Treatment plans will be reviewed, and doses to normal structures will be calculated and tabulated to determine possible relationships with toxicity outcomes. |
Measure: | Late GI toxicity, scored according to CTCAE v3.0 and CTCAE v4.0 |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | Will be calculated with a 90% confidence interval. Treatment plans will be reviewed, and doses to normal structures will be calculated and tabulated to determine possible relationships with toxicity outcomes. |
Measure: | Dosimetric predictors of toxicity (Doses to pelvic structures will be calculated and reviewed to determine possible correlations with toxicity outcomes) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | Doses to pelvic structures will be calculated and reviewed to determine possible correlations with toxicity outcomes. |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Suspended |
Lead Sponsor: | Stanford University |
Last Updated
August 4, 2021