An interventional study of MRI and 18F-PSMA1007 PET-CT in Prostate Cancer, sponsored by German Oncology Center, Cyprus. Recruiting at 1 site in Cyprus. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by German Oncology Center, Cyprus · Not applicable, Interventional, and Diagnostic
The detection and delineation of the intraprostatic tumor burden plays a crucial role in the personalized treatment of primary prostate cancer. The current gold standard multiparametric magnetic resonance imaging (mpMRI) is used to guide targeted prostate biopsies for initial diagnostic work up and for definitive focal dose-escalated radiotherapy in intermediate and high-risk prostate cancer patients.
However, mpMRI might underestimate the tumor volume and manual gross tumor volume delineation based on mpMRI underlies significant interobserver variability. Thus, novel imaging modalities are warranted to increase the detection rate and/or decrease the interobserver variability during tumor delineation.
This study will prospectively compare two promising advanced medical imaging methods: MRI-RSI and PSMA PET with the current gold-standard mpMRI for tumor detection and delineation in primary prostate cancer patients.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →German Oncology Center, Cyprus is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MRI-RSI imaging of the prostate (non-invasive)
Diagnostic Test: MRI · Diagnostic Test: 18F-PSMA1007 PET-CT · Diagnostic Test: MR-guided TRUS Prostate biopsy
MRI-RSI imaging of the prostate (non-invasive)
PET scan according to standard protocol
Biopsy according to standard protocol
Sensitivity
Sensitivity for PSMA PET, conventional mpMRI, MRI-RSI and combined modalities will be calculated on a prostate segment (n=6) level. The prostate cancer distribution in targeted biopsy cores will serve as the ground truth, calculated with the ratio of true positives to the total number of segments with the disease (true positives + false negatives).
Time frame: 24 months
Absolute GTV volumes
Conventional mpMRI, MRI-RSI and PSMA-PET derived absolute GTV volumes in ml
Time frame: 24 months
Specificity
Specificity for PSMA PET, conventional mpMRI, MRI-RSI and combined modalities will be calculated on a prostate segment (n=6) level. The prostate cancer distribution in targeted biopsy cores will serve as the ground truth, calculated with the ratio of true negatives to the total number of segments without the disease (true negatives + false positives).
Time frame: 24 months
ROC-AUC
ROC-AUC for PSMA PET, conventional mpMRI, MRI-RSI and combined modalities on a segment level in comparison with prostate cancer distribution in targeted biopsy cores on a 6 segment level (ground truth). It will be calculated by integrating the area under the TPR (Sensitivity) vs FPR (1-Specificity) curve
Time frame: 24 months
Dice Sorensen Coefficient (DSC)
The DSC is defined as followed: twice the size of the intersection of two sets, divided by the sum of the sizes of the two sets. The DSC will be used to compare different GTVs and likewise analyse the geometric overlap and the interobserver variance.
Time frame: 24 months
Dose volume histogram parameters in volume (ml) in relation to Gray
Comparison of planning parameters and DVH metrics after PSMA PET and/or MRI-RSI based radiotherapy for target volumes and organs at risk.
Time frame: 24 months
Correlation coefficient (Spearman or Pearson)
Quantitative imaging parameters from PSMA-PET, MRI-RSI and mpMRI images will be extracted and cross correlated with the ArteraAI MMAI test score (if available), Prolaris, the Ki-67 staining, the ISUP grade, serum PSA levels and the cTstage
Time frame: 24 months
Plan to share: No
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Started Aug 2025 (actual). Primary completion is estimated for Jan 2027, 17 months after the start.
Of 1,098 non-industry interventional studies with no phase under Prostatic Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 86. This study's planned 17 months is below that.
Counting every sponsor, half of 1,155 studies reached it within 43 months; a quarter within 22 and three quarters within 84.
How these figures are worked out, and which studies are left out of them.
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German Oncology Center, Cyprus