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New treatment option for Biochemically Recurrent Prostate Carcinoma
Official title Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging
ClinicalTrials.gov ID: NCT04423211
What this study is testing
What is Apalutamide?
Apalutamide is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for biochemically recurrent prostate carcinoma.
Also referred to as ARN 509, ARN-509.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase III trial tests two questions by two separate comparisons of therapies. The first question is whether enhanced therapy (apalutamide in combination with abiraterone + prednisone) added to standard of care (prostate radiation therapy and short term androgen deprivation) is more effective compared to standard of care alone in patients with prostate cancer who experience biochemical recurrence (a rise in the blood level of prostate specific antigen [PSA] after surgical removal of the prostate cancer).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- STEP 0: REGISTRATION ELIGIBILITY CRITERIA
- Patient must be male and \>= 18 years of age.
- Patient must have had a radical prostatectomy (RP) as definitive therapy for histopathologically-proven prostatic adenocarcinoma
- Patient must have biochemical recurrence (BCR) after RP, defined as follows:
- If time to BCR, defined as time to first detectable PSA ( \> lower limit of normal for assay used) after RP, is \ = 0.2 ng/mL and a confirmatory...
See the full eligibility criteria
- STEP 0: REGISTRATION ELIGIBILITY CRITERIA
- Patient must be male and \>= 18 years of age.
- Patient must have had a radical prostatectomy (RP) as definitive therapy for histopathologically-proven prostatic adenocarcinoma
- Patient must have biochemical recurrence (BCR) after RP, defined as follows:
- If time to BCR, defined as time to first detectable PSA ( \> lower limit of normal for assay used) after RP, is \ = 0.2 ng/mL and a confirmatory reading of \>= 0.2 ng/mL is required, per the American Urological...
- If time to BCR, defined as time to first detectable PSA (\> lower limit of normal for assay used) after RP, is \>= 12 months, a minimum absolute PSA of 0.5 ng/mL is required
- If the patient has a detectable PSA (\> lower limit of normal for assay used) at any time after RP AND has an eligible baseline SOC PET (PET1) with at least one positive lesion in any location, then there is no minimum...
- Patients must have no definite evidence for extrapelvic metastatic disease by conventional imaging modalities (CIM) (CT abdomen/pelvis or MRI abdomen/pelvis AND bone scintigraphy, or equivalent), within 26 weeks prior...
- Study eligible = PET using FDA-approved radiotracer and performed within 16 weeks prior to study registration
- Extra-pelvic metastases is defined as any osseous metastases and/or any extrapelvic soft tissue, lymph nodes and organ metastases; extra-pelvic is defined as superior to common iliac bifurcation, outside of standard...
- Patient must be a candidate for SOC post-prostatectomy radiation therapy (RT) to the prostate bed and pelvic nodes with androgen deprivation therapy (ADT)
- Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or...
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Patient must not have started ADT for biochemical recurrence prior to baseline PET (PET1) imaging. A short course of low-dose anti-androgen such as bicalutamide, given after baseline study PET/CT but prior to study...
- Patient must not be enrolled in another therapeutic clinical trial
- Patient must be able to lie flat and still for approximately 20-30 minutes or otherwise tolerate a PET scan and radiation treatment planning and delivery
- Patients undergoing a PET/MR must meet local institutional safety guidelines for MRI
- Patient must not have history of seizures or known condition that may cause predisposal to seizures (e.g., stroke or head trauma resulting in loss of consciousness) within 1 year prior to registration
- Patient must not have history of inflammatory bowel disease or any gastrointestinal disorder affecting absorption that is expected to increase risk of complication from radiotherapy
- Hemoglobin (Hgb) \>= 9.0 g/dL (independent of transfusion and/or growth factors within 3 months prior to Step 0 registration) (obtained within 8 weeks prior to Step 0 registration)
- Leukocytes \>= 3,000/mcL (obtained within 8 weeks prior to Step 0 registration)
- Absolute neutrophil count \>= 1,500/mcL (obtained within 8 weeks prior to Step 0 registration)
- Platelets \>= 100,000/mcL (obtained within 8 weeks prior to Step 0 registration)
- Total bilirubin \ 1.5 x ULN, must have a direct bilirubin of \< 1.5 x ULN to be eligible) (obtained within 8 weeks prior to Step 0 registration)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =\< 2.5 x institutional ULN (obtained within 8 weeks prior...
- Creatine \ 30 mL/min)
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
- Patient must not have completed a course of prior pelvic radiation therapy for any reason
- Patient must agree not to father children while on study
- Patient must be English or Spanish speaking to be eligible for the QOL component of the study
- NOTE: Sites cannot translate the associated QOL forms
- STEP 1: RANDOMIZATION ELIGIBILITY CRITERIA
- Patient must have completed a baseline SOC PET/CT or PET/MR (PET1 scan) using FDA approved radiotracer with results of extra-pelvic metastases involvement known (positive or negative). The PET1 must have been completed...
- For patients with negative extra-pelvic metastases, PET-imaging status of intra-pelvic nodes must be known (positive or negative)
- For patients with positive extra-pelvic metastases (defined as any PET positive lesions outside of standard salvage RT fields [prostate bed +/- typical whole pelvis]), the number of extra-pelvic lesions must be known (1...
The study team makes the final eligibility decision.
Where it's taking place
- Anchorage, Alaska, United States
- Fairbanks, Alaska, United States
- Phoenix, Arizona, United States
- Fort Smith, Arkansas, United States
- Arroyo Grande, California, United States
- Burbank, California, United States
- Carmichael, California, United States
- Corona, California, United States
- Duarte, California, United States
- Elk Grove, California, United States
- Encinitas, California, United States
- La Jolla, California, United States
- Lancaster, California, United States
- Los Angeles, California, United States
- Merced, California, United States
- Palo Alto, California, United States
- Rocklin, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- San Luis Obispo, California, United States
+ 223 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anchorage, Alaska, United States; Fairbanks, Alaska, United States; Phoenix, Arizona, United States; Fort Smith, Arkansas, United States; Arroyo Grande, California, United States; Burbank, California, United States and 237 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.