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Compares treatment options for Prostate Cancer (Adenocarcinoma)
Official title PRO-BOOST-LC: Whole-Gland Boost Strategies Versus SBRT Monotherapy in PSMA-Staged Localized and Locally Advanced Prostate Cancer
ClinicalTrials.gov ID: NCT07426055
What this study is testing
What is Androgen Deprivation Therapy (ADT)?
Androgen Deprivation Therapy (ADT) is an investigational medicine, given as an once-daily, being studied as a potential treatment for prostate cancer (adenocarcinoma).
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-LC is a prospective, multicenter, randomized phase II/III clinical trial for men with localized or locally advanced prostate cancer without lymph node or distant metastases, confirmed using prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT). Radiotherapy is an established curative treatment option for 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
- Male patients aged ≥18 years.
- Histologically confirmed adenocarcinoma of the prostate.
- Localized or locally advanced prostate cancer classified as cT1-4, cN0, cM0.
- Negative pelvic nodal and distant metastatic disease on baseline PSMA PET.
- NCCN favourbale or unfavourbale intermediate-, high-, or very high-risk disease.
You likely can't join if
- Evidence of pelvic nodal (cN1) or distant metastatic disease (cM1) on baseline imaging.
- Prior definitive local treatment for prostate cancer, including prostatectomy, brachytherapy, or definitive external beam radiotherapy.
- Prior pelvic radiotherapy for any malignancy.
- Prior systemic therapy for prostate cancer other than protocol-allowed neoadjuvant ADT.
- History of other active malignancy requiring systemic treatment (except adequately treated non-melanoma skin cancer).
- Contraindications to radiotherapy or anesthesia required for brachytherapy procedures.
See the full eligibility criteria
- Male patients aged ≥18 years.
- Histologically confirmed adenocarcinoma of the prostate.
- Localized or locally advanced prostate cancer classified as cT1-4, cN0, cM0.
- Negative pelvic nodal and distant metastatic disease on baseline PSMA PET.
- NCCN favourbale or unfavourbale intermediate-, high-, or very high-risk disease.
- Candidate for definitive radiotherapy with curative intent.
- ECOG performance status 0-2.
- Baseline PSA available prior to randomization.
- Ability to undergo external beam radiotherapy and brachytherapy or SBRT according to protocol.
- Planned androgen deprivation therapy (ADT) permitted according to protocol-defined risk group.
- Ability to understand and willingness to sign written informed consent.
- Evidence of pelvic nodal (cN1) or distant metastatic disease (cM1) on baseline imaging.
- Prior definitive local treatment for prostate cancer, including prostatectomy, brachytherapy, or definitive external beam radiotherapy.
- Prior pelvic radiotherapy for any malignancy.
- Prior systemic therapy for prostate cancer other than protocol-allowed neoadjuvant ADT.
- History of other active malignancy requiring systemic treatment (except adequately treated non-melanoma skin cancer).
- Contraindications to radiotherapy or anesthesia required for brachytherapy procedures.
- Severe uncontrolled comorbidities that would preclude protocol treatment.
- Inability to comply with study procedures or follow-up schedule.
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.