BridgeMD
Compares treatment options for Prostate Cancer
Official title PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate Cancer
ClinicalTrials.gov ID: NCT07426094
What this study is testing
What is Androgen Deprivation Therapy (ADT)?
Androgen Deprivation Therapy (ADT) is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for prostate cancer.
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
- PRO-BOOST-N is a prospective, multicenter, randomized phase II/III clinical trial for patients with prostate cancer and pelvic lymph node involvement (cN1M0) confirmed by PSMA PET/CT, without distant metastatic disease. Patients with PSMA PET-staged node-positive prostate cancer are potentially curable, but remain at substantial risk of distant progression despite contemporary treatment with radiotherapy, long-term androgen deprivation therapy, and, when appropriate, androgen receptor pathway inhibitors.
- 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
- Histologically confirmed adenocarcinoma of the prostate.
- Prostate cancer with clinically positive pelvic lymph nodes (cN1) without evidence of distant metastatic disease.
- Pelvic lymph node involvement limited to regional pelvic lymph nodes (obturator, internal iliac, external iliac, presacral), as assessed by...
- No evidence of distant metastatic disease (M0), including absence of non-regional nodal, bone, or visceral metastases.
- Candidate for definitive radiotherapy to the prostate and elective pelvic lymph nodes.
You likely can't join if
- Evidence of distant metastatic disease (M1), including non-regional lymph node, bone, or visceral metastases.
- Prior definitive local therapy for prostate cancer, including radical prostatectomy, whole-gland radiotherapy, or brachytherapy.
- Prior pelvic radiotherapy for any indication that would overlap planned treatment fields.
- Prior systemic therapy for prostate cancer other than protocol-allowed neoadjuvant androgen deprivation therapy.
- History of castration-resistant prostate cancer.
- Concurrent malignancy requiring active treatment, except non-melanoma skin cancer or other malignancies with negligible risk of interference with...
See the full eligibility criteria
- Histologically confirmed adenocarcinoma of the prostate.
- Prostate cancer with clinically positive pelvic lymph nodes (cN1) without evidence of distant metastatic disease.
- Pelvic lymph node involvement limited to regional pelvic lymph nodes (obturator, internal iliac, external iliac, presacral), as assessed by conventional imaging and/or PSMA PET/CT.
- No evidence of distant metastatic disease (M0), including absence of non-regional nodal, bone, or visceral metastases.
- Candidate for definitive radiotherapy to the prostate and elective pelvic lymph nodes.
- Planned treatment with androgen deprivation therapy with or without androgen receptor pathway inhibitors according to protocol.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Adequate organ function allowing delivery of protocol-defined radiotherapy and systemic therapy.
- Age ≥18 years.
- Ability to understand and willingness to sign a written informed consent.
- Evidence of distant metastatic disease (M1), including non-regional lymph node, bone, or visceral metastases.
- Prior definitive local therapy for prostate cancer, including radical prostatectomy, whole-gland radiotherapy, or brachytherapy.
- Prior pelvic radiotherapy for any indication that would overlap planned treatment fields.
- Prior systemic therapy for prostate cancer other than protocol-allowed neoadjuvant androgen deprivation therapy.
- History of castration-resistant prostate cancer.
- Concurrent malignancy requiring active treatment, except non-melanoma skin cancer or other malignancies with negligible risk of interference with study outcomes.
- Severe uncontrolled comorbidities that would preclude safe delivery of radiotherapy or systemic therapy.
- Any condition that, in the opinion of the investigator, would interfere with patient safety or compliance with the study protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Zamość, Lublin Voivodeship, Poland
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 Zamość, Lublin Voivodeship, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.