RISK-ADAPT Protocol in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
A Pragmatic Phase 2 Trial of Risk-Adapted Treatment Approaches Including Treatment De-escalation to Minimize Adverse Effects of Hormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer.
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study is for adults with prostate cancer that has spread and still responds to hormone treatment. It tests treatment matched to each person's cancer risk, followed by less treatment. Researchers will check cancer control, side effects, quality of life, and sexual function.
This is a prospective, interventional, non-randomized, phase 2 study to assess oncologic outcomes of metastatic hormone-sensitive prostate cancer (mCSPC) patients who receive a risk-adapted treatment approach followed by treatment de-escalation at the Medstar Health network. A pragmatic design will be implemented in order to make the study available to patients at greatest needs from minority populations in the community. Additional assessments include quality-of-life (QoL) and sexual function changes as well as correlative studies. A maximum of 108 patients will be enrolled in this study. The investigators hypothesize that with a risk-adapted treatment approach followed by treatment de-escalation, more than 50% of patients will have radiographic progression-free survival (rPFS) at 36 months. Additionally, the investigators hypothesize that the risk-stratified de-escalation approach will result in fewer treatment-related adverse events and better QoL, compared to historical controls.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You have prostate cancer that has spread and still responds to hormone treatment. Your doctor says you can receive standard treatment.
- For low-risk cancer, standard treatment includes hormone-lowering treatment (ADT), a drug that blocks hormone signals (ARPI), and radiation to the prostate.
- For low-risk cancer, up to 8 weeks of prior ADT or ARPI treatment for cancer that has spread is allowed, but prior docetaxel chemotherapy is not.
- For high-risk cancer, standard treatment includes ADT and an ARPI, with or without docetaxel chemotherapy.
- For high-risk cancer, up to 8 weeks of prior ADT, ARPI, or docetaxel treatment for cancer that has spread is allowed.
- You can give informed consent, meaning you understand and agree to join. You are willing to follow the treatment plan and attend follow-up visits.
Who can't join
- The study doctor thinks the study, its drugs, or the plan to reduce treatment is not safe or right for you.
- You have had chemotherapy other than docetaxel for prostate cancer.
- You have had radioactive medicines for prostate cancer.
- You had radiation treatment within 2 weeks before starting study treatment.
- You had an ARPI for cancer that had not spread within 6 months before being diagnosed with cancer that had spread.
- You are in another study using an experimental drug, or were recently in one. The required gap is at least 28 days or four times that drug's half-life, whichever is longer. A half-life is the time it takes the body to clear half the drug.
- The study doctor thinks you cannot swallow pills.
- You have cancer in the tissues and fluid around the brain and spinal cord, called leptomeningeal disease.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Adult patients with metastatic castrate sensitive prostate cancer that are eligible for standard of care (SOC) per treating physician. a. Low risk SOC: ADT + ARPI + radiation to the prostate i. For patients with low-risk disease (defined in Section 8.1), prior treatment with ADT or ARPI for up to 8 weeks for mCSPC is permitted; however, prior treatment with docetaxel is not allowed. b. High risk SOC: ADT + ARPI +/- docetaxel i. For patients with high-risk disease (defined in Section 8.1), prior treatment with ADT, ARPI, or docetaxel for up to 8 weeks for mCSPC is permitted. 2. Patients who can give informed consent and are willing to comply with follow-up visits and treatment plans. Exclusion Criteria: 1. Patients for whom, in the opinion of the investigator, participation in the study, use of the drugs outlined in the study, or use of the risk-adapted treatment de-escalation strategy is not appropriate or safe. 2. Patients who have received prior treatment with any of the following: 1. Chemotherapy other than docetaxel for prostate cancer any time prior to enrollment; 2. Radiopharmaceuticals for prostate cancer any time prior to enrollment. 3. Patients who have received treatment with radiotherapy (EBRT, brachytherapy, or radiopharmaceuticals) within 2 weeks before prior to the start of study treatment. 4. Patients with prior treatment with an ARPI for non-metastatic disease within 6 months of diagnosis of metastatic disease are not eligible. a. Note: Patients who were diagnosed with metastatic disease or more than 6 months after treatment with an ARPI non-metastatic disease are eligible. 5. Patients who had previous (within 28 days before the start of study drug or 4 half-lives of the investigational treatment of the previous study, whichever is longer) or concomitant participation in another clinical study with investigational medicinal product(s). 6. Patients with an inability to swallow oral medications in the opinion of the clinical investigator. 7. Patients with leptomeningeal disease.
Study sites (1)
DC
- Georgetown University Medical Center- Lombardi Comprehensive Cancer Center · Washington D.C., DC 20007Paul Leger, MD · Principal investigatorMore trials in Washington D.C.