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New treatment option for Prostate Cancer Metastatic
Official title Metastasis Directed Stereotactic Body Radiotherapy for Oligo Metastatic Hormone Sensitive Prostate Cancer
ClinicalTrials.gov ID: NCT04983095
What this study is testing
What is androgen deprivation therapy?
androgen deprivation therapy is an investigational medicine, being studied as a potential treatment for prostate cancer metastatic.
Also referred to as gonadotropin releasing hormone-agonist, gonadotropin releasing hormone-antagonist.
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
- The study is an open label, multi-centre, randomized phase III study. The patients will be randomised in a 1:1 ratio to treatment consisting of Arm A: MD-SBRT in addition to standard treatment Arm B: Standard treatment Study population: Patients with hormone sensitive prostate cancer (HSPC) with oligometastatic disease detected by PSMA-PET/DT.
- 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 prostate cancer (ICD-O-3 C61)
- WHO/ECOG performance status 0-1
- 1-3 skeletal or extra pelvic lymph node metastases detected by PSMA-PET/CT in de novo prostate cancer or PSA-relapse after definitive RT or...
- Willing and able to provide informed consent-
You likely can't join if
- Castration resistant prostate cancer (progression with castrate levels of testosterone)
- Any treatment known to affect PSA (including ADT) for prostate cancer within 6 months (exception: ADT started due to oligometastatic disease within 2...
- Patient eligible for other treatment (e.g., early docetaxel) than standard treatment described in the protocol as judged by treating physician
- Life expectancy \<3 years by any reason, including concomitant or previous malignancies
- Previous radiotherapy or surgery that may interfere with the planned treatment (including intra-prostatic recurrence if previous RT to the prostate)
- \> 3 PSMA-PET/CT positive target lesions (excluding the prostate and regional lymph node metastasis in de novo patients or prostate bed and or...
See the full eligibility criteria
- Histologically confirmed prostate cancer (ICD-O-3 C61)
- WHO/ECOG performance status 0-1
- 1-3 skeletal or extra pelvic lymph node metastases detected by PSMA-PET/CT in de novo prostate cancer or PSA-relapse after definitive RT or prostatectomy
- Willing and able to provide informed consent-
- Castration resistant prostate cancer (progression with castrate levels of testosterone)
- Any treatment known to affect PSA (including ADT) for prostate cancer within 6 months (exception: ADT started due to oligometastatic disease within 2 weeks of study entry)
- Patient eligible for other treatment (e.g., early docetaxel) than standard treatment described in the protocol as judged by treating physician
- Life expectancy \<3 years by any reason, including concomitant or previous malignancies
- Previous radiotherapy or surgery that may interfere with the planned treatment (including intra-prostatic recurrence if previous RT to the prostate)
- \> 3 PSMA-PET/CT positive target lesions (excluding the prostate and regional lymph node metastasis in de novo patients or prostate bed and or regional lymph node metastasis in recurrent patients)
- PSMA-PET verified metastases other than skeletal or lymph nodes
- Metastases in base of scull and/or calotte
- Any target lesions not treatable with image guided RT (IGRT) due to overlap with previous RT fields or exceeded dose constraint to OAR(s) as specified in study protocol
The study team makes the final eligibility decision.
Where it's taking place
- Lund, Lund, Sweden
- Stockholm, Region Stockholm, Sweden
- Stockholm, Stockholm County, Sweden
- Umeå, Umea, Sweden
- Jönköping, Sweden
- Örebro, Örebro County, Sweden
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 Lund, Lund, Sweden; Stockholm, Region Stockholm, Sweden; Stockholm, Stockholm County, Sweden; Umeå, Umea, Sweden; Jönköping, Sweden; Örebro, Örebro County, Sweden. 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.